Sexual health promotion in people with severe mental illness: the RESPECT feasibility RCT

The nature of the problem

The World Health Organization’s (WHO’s) definition of sexual health5 includes not just freedom from sexually acquired infections; it defines it as experiencing one’s own sexuality that is satisfying, positive and respectful, and free from exploitation and violence.

Most people with SMI live in the community and many are sexually active throughout their adult life. It is hard to estimate the level of sexual activity of people with SMI in the UK as there have been no studies undertaken; however, in a systematic review of 52 studies (predominantly conducted in the USA, with a few in Australia, India and Canada),6 it was estimated that just under half (44%) of people with SMI were sexually active in the preceding 12 months. In a reanalysis of data from a previous study, Bonfils et al. 7 found that 30% of people with SMI had been sexually active in the last 3 months prior to data collection.

Although sexual activity is generally less frequent than levels reported in data for the general adult population6 for a range of reasons (impact of mental illness, medication and/or lack of sexual partner), sexual practices seem to involve a greater proportion of ‘high-risk behaviour’ such as condomless vaginal and anal sex. 8

Informed about sexual health

Several studies indicate that there are gaps in information and awareness related to sexual health issues for people with SMI (Table 1).

Mental health service response to sexual health

Sexuality and sexual health issues are rarely discussed with service users in mental health settings. 22–24 Service users themselves value positive sexual relationships,20 yet because of ‘self-stigma’ and other vulnerabilities they feel limited in their choices of sexual partners and, therefore, more vulnerable to sexual exploitation and abuse in relationships. 16

In focus group discussions held in two different NHS services in England,4 mental health clinicians reported awareness of a range of sexual health needs of the people in their care, but some reported that they would usually avoid raising the topic of sexuality, sexual health and abuse. The reasons for this ranged from fear of offending the person, concerns about destabilising their mental state, feeling that they lacked the knowledge to address the sexual health issues that may be raised, and lack of knowledge about local sexual health services. Despite this, the participants recognised that sexual health is an important aspect of people’s lives. They were able to describe a number of issues that they had become aware of related to the topic and they saw promotion of sexual health, as well as facilitating access to appropriate family planning and sexual health clinics, as part of their clinical role. In addition, they recognised that they could play an advocacy role in terms of assisting people to get access to appropriate family planning and sexual health clinics. However, they also acknowledged that their knowledge regarding sexual health and sexual health services was limited. These findings were echoed in a survey of mental health staff in England and Australia about sexual health provision. 25 Participants from both countries reported that very limited sexual health work was being undertaken in routine practice but they did see it as part of their role. Therefore, in order to address this issue, mental health staff require training and guidance in relation to sexual health issues in SMI and in how to engage people in conversations about sexual behaviour, and offer advice about where to access help for contraception and sexual health concerns.

Despite experiencing significant health disparities, people with SMI struggle to get their wider physical needs assessed and treated. 2 Therefore, promoting the sexual health of people with SMI could fall into routine practice in mental health services that can often be the only health service that some people with SMI are engaged with.

Current sexual health concerns in England

Sexual health is an important public health concern in England26 and there are key areas that require attention for the promotion of sexual health in the general population. Overall, the incidence of new diagnoses of many STIs has remained stable in recent years but there are some disproportionate rises in STIs in specific populations. Chlamydia is the most common STI (almost half of all STIs diagnosed are chlamydia) and the impact of STIs remains greatest in young people aged under 25 years. There has been a 21% rise in gonorrhoea and a 19% increase in syphilis in men who have sex with men (MSM), and this is possibly as a result of an increase in condomless sex. 27

HIV rates are declining for the first time since it was first identified 30 years ago. 28 The mortality of someone diagnosed promptly (shortly after infection) with HIV is comparable with the general population for the first time. This is because of access to effective treatments to suppress the virus. However, this is not the case for late diagnosis and those diagnosed late have a greater risk of death within the first 12 months of diagnosis. Therefore, people engaging in condomless sex with new or casual partners of unknown HIV status should be tested for HIV every 3 months, and gay/bisexual men and other MSM should be tested for HIV every year.

In summary, in the general population, STIs are most prevalent in young people and in specific groups, such as MSM (who may be more likely to engage in high-risk sexual behaviours). Early detection and treatment of STIs is crucial, not only to improve the prognosis and prevent further harms (e.g. untreated chlamydia leading to fertility problems) but, in some cases, to prevent mortality (e.g. late diagnosis of HIV is associated with death from AIDS within 12 months of diagnosis). In addition, the treatment of STIs (and HIV) can also prevent onward transmission, hence the term ‘testing as treatment’. Therefore, it is essential that all health professionals are aware of the current issues in sexual health, able to ask questions about sex and sexuality as part of routine care, able to offer advice about testing and treatment, and able to offer access to condoms in the local area.

Policy context

There is no specific mention of people with mental illness in the recent Public Health England sexual health policy. 29 However, there is some emerging awareness of this issue in mental health policy, specifically within the ‘improving physical health for people with mental illness’ agenda. A recent document from the Department of Health3 (Improving the physical health of people with mental health problems. Actions for mental health nurses) includes a chapter on sexual health, outlining sexual health needs, and care responses to those needs, by mental health nurses. In addition, sexual health is mentioned (albeit very briefly) in a recent joint report by the Academy of Medical Royal Colleges and the Royal Colleges of General Practitioners, Nursing, Pathologists, Psychiatrists, Physicians, the Royal Pharmaceutical Society and Public Health. 30 Both of these documents support the role of mental health nurses and psychiatrists in promoting sexual health in mental health care settings.

Justification for sexual health promotion in mental health

Sexual health promotion activities such as regular check-ups, increasing knowledge and awareness of risky sexual behaviour and how to keep oneself and sexual partners protected are essential in terms of prevention of STIs, as well as in detection. Untreated STIs can lead to significant health problems (e.g. the human papilloma virus can lead to cervical cancer, and other STIs such as chlamydia can result in infertility). BBV such as hepatitis B and hepatitis C can result in premature death through the development of cirrhosis and liver cancer in the long term. Comorbidity of HIV and SMI, such as schizophrenia, poses significant challenges for both the person themselves as well as in the provision of treatment. 31 The treatment and management of HIV requires early detection and adherence to a complex medicine regime to suppress the virus. This requires engagement with services and treatment adherence. Early diagnosis and treatment has resulted in people living well with HIV and has the potential to reduce onward transmission (treatment as prevention) by suppressing the virus to the extent that it is not present in sufficient quantities in blood and body fluids. However, many people are receiving a late diagnosis of HIV and are starting treatment after the point of maximum benefit. 28 This latest data suggests that 13% of HIV diagnoses occur at a later stage of the disease and the prognosis is likely to be poorer. 28

Evidence to support sexual health promotion interventions

Current evidence around improving sexual health for people with SMI has been conducted in the USA and Brazil, where a different set of cultural, organisational and socioeconomic factors exist from those in the UK.

Simply providing information (e.g. leaflets) alone is insufficient to bring about health behavioural change, and behavioural interventions that address knowledge, confidence, attitudes/motivations and behavioural skills are recommended. 19 There have been two recent literature reviews that have examined the evidence for sexual health promotion interventions and found that the evidence is currently equivocal. 32,33 All studies were conducted in the USA and most were group-based interventions. Some studies34,35 demonstrated a significant reduction in condomless sex, when compared with a control group, and some studies showed no overall effect. 36,37 Both reviews32,33 recommended that further research should be undertaken in the UK to develop and evaluate an intervention, as well as the feasibility of undertaking a study that addresses sexual health needs in SMI.

Stage 1: intervention development

1. To undertake a stakeholder consultation to inform the development of an intervention.

2. To use intervention mapping to develop an evidence-informed and co-produced manualised sexual health promotion intervention.

Stage 2: feasibility randomised controlled trial

Objective 1 was to assess the feasibility and acceptability of undertaking a trial by:

1. quantitatively assessing the numbers screened, numbers eligible and those agreeing to participate

2. qualitatively assessing the feasibility and acceptability of the randomisation process, as well as the intervention

3. quantitatively evaluating the acceptability of the intervention by assessing retention in treatment (number of sessions attended)

4. quantitatively evaluating the acceptability of the proposed method of data collection and data collection tools by assessing overall questionnaire response rates and for each data collection tool.

Objective 2 was to identify the key parameters to inform the sample size calculation for the main trial: the standard deviation (SD) of the primary outcome measure, quantify the average caseload per therapist and tentatively explore clustering within therapist using intracluster correlation coefficients (ICCs).

In addition, a number of secondary aims were anticipated to be met by this study, especially as this was the first UK study to our knowledge to collect data specifically about sexual health and service use of people with SMI:

• to develop an understanding of the sexual health needs of people with SMI who use NHS mental health services

• to establish the use and uptake of sexual health services by people with SMI

• to establish the barriers to accessing information and service provision

• to establish workforce capacity to undertake such an intervention in mental health services

• to explore cost-effectiveness in preparation for a future large trial

• to develop recommendations for care pathways between mental health and sexual health service.

Step 1: needs assessment

Chapter 1 presented the background literature related to sexual health issues for people with SMI. A needs assessment sets out the context and the target population and defines their specific needs in order to design a targeted and relevant intervention.

Step 2: mapping

The first step involved mapping the key elements from manualised interventions that were identified in the literature review33 in terms of behaviour change objectives and underpinning mechanisms of change and corresponding change techniques and implementation strategies. Walsh et al. 33 undertook a systematic review of interventions to promote sexual health for people with SMI. Eleven studies were identified and synthesised. All were group interventions with people who were defined as living with SMI and all took place in mental health provider settings.

1. State the expected outcomes for behaviour and environment:

   1. increased use of sexual health services

   2. reduced unprotected sex (increased use of contraception including condoms).

2. Specify performance objectives for behavioural and environmental outcomes:

   1. planning skills

   2. problem-solving

   3. assertive communication in negotiating safer sex.

3. Select determinants for behavioural and environmental outcomes:

   1. increased knowledge of sexual health issues

   2. increased motivation to adopt safer sexual practices

   3. more positive attitudes to using condoms.

Steps 3 and 4: selecting techniques and intervention components

Manuals from previous trials were obtained (note that an adapted version of the Susser et al. Sex, Games and Video-tapes34 manual was also used in the Berkman et al. 36 and Berkman et al. 41 RCTs) and the content was coded according to the IMB model in terms of anticipated impact on information, motivation and behavioural skills (Table 2).

Stakeholder consultation

Several consultation meetings were held during the stage 1 phase of the RESPECT study. The aim of these events was to obtain views from a range of stakeholders in order to refine the content and mode of delivery to meet the needs of people with SMI (Table 3). In these meetings, the prototype of the intervention was provided and the discussion was then focused on how best to adapt these components to suit both the service users’ needs as well as the service setting, feasibility and the likely uptake of intervention components. Modifications based on these discussions were then made. The range of participants included:

• people with lived experience of SMI, people who cared for people with SMI, mental health nurses, sexual health workers, drug and alcohol workers, and support workers.

TABLE 3 - Stakeholder input to the intervention manual

Themes	Feedback	How feedback influenced manual development
Who should be included?	Discussion about who the manual would be suitable for. Consensus that all people interested in taking part will be included regardless of current relationship status	Eligibility criteria were wide to include as many people as possible
Number and length of sessions	Original plan suggested was 6 × 30-minute sessions. Some variation in numbers suggested, and suggestion to reduce number of sessions but increase the time of them	The manual was designed to be delivered in 3 × 1-hour sessions. However, it was divided into components within the session so that there could be flexibility in delivery
Frequency	Frequency should be weekly to space out the intervention enough for people to absorb information and to not be too intense	The intervention was recommended to be delivered weekly but also allowed some flexibility (holidays, work commitments, etc.). We also allowed interventionists to offer less sessions but more content per session to cover the material
Mode of delivery	We asked whether or not it should be over telephone or face to face: consensus was face to face Be flexible in the delivery so that people can opt-out of some sessions if felt irrelevant or if they just did not want to do them	We changed the plan to only being delivered face to face
Recording intervention	Be able to record important or interesting observations from the sessions in a more systematic way so that participants’ progress can be tracked. For example, might it be useful to rate how well people do in the condom demonstration? This could be in a column next to each section in the session guide, in addition to the notes section at the end	We decided not to assess people’s skill as this was felt too threatening and stressful
Location of delivery	Location? Appropriate to deliver in people’s homes? Need for privacy Factors in who can be present (e.g. family or a partner)	We offered the choice of location dependent on participant preference. We advised the interventionists to check out the privacy or otherwise of the home visit (being mindful of other people being present, or children, etc. Advised to use a clinic room if that was an issue)
Modifications for the SMI population	Provide intervention sequentially and offer a recap at the start of the next session and at the end; promote cohesiveness between the sessions to help learning and retention	Incorporated introduction and recap into each session
Training for interventionists	Sexual health services involved to deliver awareness training	We included a sexual health practitioner in the development of the manual and also attendance at the initial intervention training event
Qualities of interventionists	It was deemed important that the person delivering the intervention should be aware of all types of sexual behaviour and sexual relationship and to be non-judgemental, be able to build rapport at the start of the intervention and avoid jargon	We incorporated this into the interventionist training
Safety and confidentiality	There was a need for the boundaries of confidentiality in the intervention to be clarified and also for the interventionists to understand what to do regarding disclosures that related to safeguarding	This was attended to in the training and the interventionists were advised that in the first instance as employees of the NHS service that they follow NHS trust processes first (especially if the issue was urgent) and then inform their local research and development department or the RESPECT study researcher
Information on STIs and HIV	There would need to be some content related to increasing the awareness of and knowledge about various STIs and HIV	The decision was made to include quizzes on the transmission of both STIs and HIV
Contraception	Make sure that there is discussion of other forms of contraception The nurses delivering the intervention should be aware of how certain forms of contraception can affect those with diabetes and are contraindicated for people on some antipsychotic medication because of the associated risk It was felt that use of female condoms should be demonstrated Need for demonstration of female condoms, preferably with model vagina	A section on the whole range of contraceptives was included: ‘what’s in the bag’ We did not include any input on sexual dysfunction as the HTA commissioning brief was specifically to exclude sexual dysfunction We did not include a specific component on female condom use (because they are not commonly used and they are expensive). However, we did advise people to seek advice regarding female condom use from local family planning services
Condoms	There was a consensus that the person demonstrating how to put on a condom should not hold the condom demonstrator between their legs There should be more emphasis on the importance of getting the condom on the right way round. Discuss more explicitly about what it should look like. If it’s on right it looks like a Mexican hat or bobble hat. Discuss what should be done if you put it on the wrong way round (i.e. throw it away). If you notice it is difficult to roll down it is probably on the wrong way Using other forms of contraception other than condoms. Without acknowledging this the intervention could be taken as suggesting that you will have to use condoms for the rest of your life. This is both demoralising and could stigmatise mental health service users by denying them the usual progression of a relationship that others experience Gel charging should be included in the condom use section. This is when a pea-sized amount of lubricant is placed in the tip of the condom before putting it on. Not too much though as this will make it slip off. This is helpful for men who say they do not like the feel of condoms Warnings about fingernails and rings ripping the condoms should be included in the intervention	Condom demonstrator not to be held between legs Specific advice regarding getting the condom the right way round was included in a script and the interventionists all practised putting a condom on and off as part of the training We incorporated gel charging and also gave out some condoms and lubricant gel sachets to participants in the intervention We covered all forms of contraception
Assertiveness skills	Generally in this assertiveness section there needs to be some flexibility over the thing being negotiated depending on the individual participant’s circumstances. Suggest role play within sessions as a good way of building confidence	We used discussion exercises and a role play if the person was comfortable doing so
Relationships	There was a discussion over the use of the word ‘friend’ in the relationship game and it was suggested to change it to ‘friend or partner’ There should be a section dedicated to how relationships progress	We used ‘friend’ at the request of our patient and public involvement group We did not include a section on ‘how relationships progress’ as it was felt that this could be drifting away from a sexual health focus
Range of sexual practices	There should be more information about the alternatives to penetrative sex. This is helpful for the times when a condom is not available and also for building confidence to explore sexuality	There is an exercise (traffic lights) in which alternatives to penetrative sex are discussed
Local information and signposting	Information be supplied regarding sexual health clinics as an external resource	All participants received a localised advice sheet regarding services for sexual health, intimate partner violence and family planning

At each event, notes were taken of the discussion and passed to the chief investigator. A simple thematic framework was developed based on the content of the discussions.

Table 3 summarises the range of issues discussed in the stakeholder events and the response to these issues in the intervention development. The overall responses were positive and feedback from each discussion was used to modify the intervention procedures and information packs.

In summary, there was significant overlap in the content identified from a thematic analysis of the previous study intervention manuals (see Table 2) and the content suggested in the stakeholder and PWLE discussions. The addition was the suggestion of the inclusion of contraception more broadly than just a focus on condoms. In addition, people generally felt that the tone of the intervention should be positive and focusing on ‘health’, ‘being safer’ and having ‘positive intimate relationships’.

Two main behavioural changes were anticipated for the intervention: a reduction in condomless sex and an increase in access to sexual health and family planning services. Stakeholder feedback had been clear that they wanted a broader view of sexual health that included contraception within a monogamous relationship and that they wanted the content to reflect the positive aspects of intimate relationships.

The intervention content has been aligned with the IMB model (Figure 3). To achieve those behavioural outcomes, it is postulated that the person requires knowledge of HIV and STIs, as well as the range of contraception available (and what services are available locally). As well as having that information, increasing perceptions of self as potentially at risk is important. In the IMB model, information and motivation to adopt safer sexual practices is mediated by behavioural skills. In the intervention, key skills were included and were demonstrated by the interventionist and then the person was invited to try it out for themselves. There were also exercises in developing problem-solving skills and planning skills, which are important for supporting self-efficacy for new behavioural strategies.

FIGURE 3.

Content of the intervention mapped on to the IMB model.

The outcome measures chosen for the study related to the components of the model:

•  information – measured with the knowledge about HIV questionnaire (HIV-KQ)

•  motivation – measured with the ‘motivations to engage in safer sex’ scale

•  behaviour – measured with the Sexual Risk Behaviour Assessment Schedule (SERBAS), self-reported condomless sex acts, the Behavioural Intentions for Safer Sex measure and the Condom Use Self-Efficacy Scale (see Chapter 3 for more information about the measures).

Outline of intervention

The intervention manual can be seen on the National Institute for Health Research journals library website.

Information giving about sexual health

In some of the previous group interventions,34,35 the information had been imparted using didactic methods as well as interactive exercises. It was felt by PWLE that a didactic approach would be too intensive for an individually delivered intervention, so a set of quizzes was developed to be used to help establish what is already known and where any knowledge gaps exist. The interventionist allowed time to complete the quizzes and then went through the responses, and addressed the items that were incorrect. In terms of introducing the quiz it was really important to make it clear that most people in the general population have things to learn about sexual health and that it is OK not to get it all correct.

Correct use of the male condom

After the knowledge quizzes, the interventionist picked up on a specific item from one of the quizzes (‘using condoms always prevents pregnancy’) and linked this to the fact that condoms can fail if used incorrectly. The next section focused on the correct use of condoms and (if the person agrees) the interventionist runs through a (scripted) description and physical demonstration of how to correctly put on and off a condom using a plastic condom demonstrator. Session 2 went into condom use in more detail, but it was felt that if there was poor attendance at the subsequent sessions then having the condom demonstration in session 1 would ensure that all participants received this.

Types of contraception

The final part of session 1 was a general discussion of contraception using ‘what’s in the bag’, which was a bag containing information and photos of all the variants of contraception available. They were grouped as barrier, non-hormonal and hormonal. At the end of the session the next appointment was arranged.

Participant eligibility

Recruitment into the trial

Potentially eligible participants were identified using three main methods: screening of caseloads for potentially eligible people, direct approach by research staff in clinic waiting rooms and self-referral (via study e-mail, telephone or via an online form on the study website). The details for self-referral were provided on all participant-facing materials such as the posters and leaflets.

Caseload screening and eligibility assessment process

Local researchers [known as Clinical Studies Officers (CSOs)] employed by the CRN based in each site’s R&D office worked with the trust’s clinical staff to promote the study and undertake caseload screening for potentially eligible participants using the eligibility criteria. Screening was undertaken in two main ways. The initial approach was to visit CMHTs and talk through each individual case manager’s caseload with them, creating a list of people for the case manager to informally approach. They were given one study information pack for every person identified. The second method was the CSO staff screening caseloads via the electronic records system and then verifying the list with case managers. Once a member of the team had verified that it was appropriate to make an approach, the CSO sent out a study information pack with a letter signed from their case manager or the team manager.

Participant-facing information and study information pack

A simple leaflet and poster introducing the study were developed and distributed widely in each study site. In addition, potentially eligible people received a ‘pack’ (either face to face or by post). The information pack included an invitation letter, a participant information sheet (PIS), a consent to contact (CtoC) form and a baseline feedback questionnaire.

Completed CtoC forms were returned (by fax scanned, by hard copy or verbally) to the CSO research team at each NHS site. Once a CtoC form was received by post at the York Trials Unit, the details were passed to the relevant RESPECT study researcher: either one in the north of England (based at the University of Huddersfield) or one in the south of England (based at University College London).

Self-referral

The participant-facing materials were all designed to offer an option of self-referral to the study. The study posters and leaflets about the study contained a Quick Response code (QR code) and website address to the project website. This website was designed to provide information about the study for staff and potential participants, as well as other interested parties. The posters and leaflets provided a brief description of the study and methods for contacting the RESPECT study research team directly. Local CRN staff and RESPECT study researchers attended various service user groups/events (e.g. recovery colleges, creative groups and clinics) to give out leaflets. At those events, CtoC (by a researcher) was obtained verbally or with the CtoC form. This method of recruitment was utilised to ensure that all potentially eligible participants had the opportunity to take part. The method of recruitment was recorded to inform the most effective recruitment strategies for the main trial. A study e-mail address was set up specifically to manage enquiries regarding the study that was managed by the RESPECT study research team. By contacting the RESPECT study research team directly, it was assumed that the potential participant had implicitly agreed to contact by the research team and, therefore, a CtoC form was not required. However, a record of the contact and any contact information was recorded by the research team.

Once a self-referral had been received, one of the research team made contact by e-mail or telephone to determine interest and eligibility, and to answer any initial queries and concerns that the potential participant had about participating. If they were interested in pursuing involvement, they were sent a study information pack (information sheet and consent form). They were also informed verbally that the researcher would be in touch with their local NHS service R&D team to inform them of the person’s interest, and that their case manager would also be contacted by the CSO in the R&D team to check the person’s eligibility for the study. The RESPECT researchers confirmed that no information would be shared other than their expression of interest in taking part, and the fact that they had self-referred to the research team. In addition, no clinical information would be shared from the NHS back to the RESPECT study team other than whether or not the potential participant met the eligibility criteria.

Flow of participants from identification to entry into study

The numbers of people who were screened, eligible and had consented to participate were recorded when possible. Eligible patients who did not wish to take part (i.e. were unwilling to give consent) and those found to be ineligible went on to receive usual care from the service without prejudice.

As the primary objective of this trial was feasibility, reasons for participation and non-participation were collected by various means to inform future studies. Clinicians handed out feedback forms to those with whom they discussed the study. Service users who received a study information pack by post were contacted by CSOs by telephone 2 weeks later to discuss the information and gauge if there was any interest in participating or not. The feedback form was completed over the telephone for both potential participants and for those who declined to pursue this.

Participant follow-up

The original plan was that all participants in the RESPECT study would be followed up with a repeat of the questionnaires/interview at 3 months and 6 months post randomisation (see Report Supplementary Material 2). However, as a result of requiring an extension to the recruitment period, and balancing the need to complete the study within a new time frame, an agreement was reached between the research team and the funder to only collect 3-month data on any participants who entered the trial after October 2017 and for all recruitment to be completed by 31 December 2017. This allowed for all the follow-up data collection to be completed by 31 March 2018.

Intervention arm

In addition to usual care, people who were randomised to receive the intervention were offered three 1-hour sessions of a manualised intervention. This was delivered by a specifically trained mental health worker based in the NHS sites (specific training was provided by the RESPECT study team) and was supported by a specifically devised manual and intervention pack. The sessions were delivered in a private room at the local clinical service or at their home. The intervention was delivered as soon as possible following randomisation and before the 3-month follow-up point. The intervention is described in more detail in Chapter 2.

Control arm

Participants randomised to receive TAU continued to receive their usual care. The TAU for sexual health (including contraception) included their local primary care and/or specialist sexual health services. All participants, irrespective of allocation, received a leaflet listing the local sexual health, family planning and domestic abuse services relevant to their local area, and some condoms at the point of baseline data collection.

The participants’ general practitioners (GPs) were sent a letter informing them that the named person was taking part in the trial and also notifying them of the arm of the trial to which they had been allocated. The RESPECT study information leaflets and sheets contained a link to the study website that also contained links to national helplines and resources related to sexual health and relationships (www.respectstudy.co.uk; accessed 5 September 2019).

Primary outcomes: feasibility parameters

To establish feasibility, the key parameters were whether or not there were eligible people in the mental health services, and whether or not they could be recruited to the study and give informed consent to participate. Therefore, the recruiting sites were required to complete logs of screening and eligibility numbers, as well as how many CtoC forms (or other forms of CtoC, e.g. telephone calls, verbal requests) were received. This information was to be recorded by each research site on a Microsoft Excel (Microsoft Corporation, Redmond, WA, USA) spreadsheet and reported to the trial team via e-mail on a monthly basis.

In addition to recruitment, retention in the trial at subsequent time points was of interest.

To quantitatively assess feasibility of data collection as well as the completeness of the data within the questionnaires, each outcome measure was reported in terms of completeness as a percentage for the baseline and the 3- and 6-month follow-up time points.

Retention in intervention was quantitatively assessed as a percentage of the content completed and the number of sessions attended. There was no established a priori parameter for what would be an acceptable ‘dose’ of intervention; instead, any attendance would be counted as a favourable outcome given the novelty of the topic, and the challenges faced by people with SMI in engaging with additional interventions in addition to routine care. Observing the pattern of attendance would also inform the design of future intervention studies.

Development of the interview schedule

The interview topic guide was developed in conjunction with the lived experience researchers and reflected the research questions for the study. A teleconference was held prior to the start of the qualitative study with the four people who would be conducting the interviews and the chief investigator in order to plan the telephone interviews, and to ensure consistency of approach. The two RESPECT study researchers already had permission from the NHS sites to undertake the research and have access to participants as part of the wider ethics and governance approvals. For the lived experience researchers, they each obtained ‘letters of access’ from the relevant NHS sites.

The interview topic guide was employed to standardise the procedure across all interviews. Interview questions focused on the participant’s reasons for taking part, their recall of the recruitment strategies, their views on the presentation of study information (PIS and leaflet), the randomisation process and their experience of meeting the researcher and the interventionist (when applicable). The telephone interviews lasted approximately 30 minutes and were audio recorded with the participant’s permission.

Procedure

The researcher at Huddersfield was informed by e-mail that a participant had confirmed verbally that they were still interested in taking part in the qualitative interview.

The researcher undertaking the telephone interview was not the same person who had been involved in the recruitment and data collection during trial participation to ensure some level of independence, and to minimise social desirability in responses to questions about how they had found the experience of being a participant.

Data protection

The participants’ contact details were stored in the secure trial database that could only be accessed by the RESPECT study team. To pass these contact details to the two lived experience researchers for them to be able to conduct the interview, the lead researcher sent the name and preferred contact details in a password-protected document in an e-mail. They were asked to destroy these documents after use, and not to store personal details such as names and telephone numbers in their own telephones or anywhere else. To ensure privacy and to protect data, the telephone interviews were conducted in private (i.e. where no-one could overhear), recorded by using a password or PIN (personal identification number) protected digital recorder, and the recordings were transferred securely to the University of Huddersfield as soon as possible following the interview and then deleted from the device. The data were transcribed, stored and subsequently analysed at the University of Huddersfield. Anonymity was ensured by assigning a unique identification code specific to the study to both the electronic sound files and transcripts of individual interviews. This study identification list was retained at Huddersfield. The researchers were informed of the participant’s name and contact details for the purposes of arranging the telephone interview and this information was sent in a password-protected word document via e-mail. The researchers destroyed this document once the interview had taken place.

Ethics approval

The qualitative study was approved by East Midlands – Derby REC (reference number 16/EM/0334).

Analysis

The analysis was thematic54 and analyst driven (deductive) and a framework approach55 was employed to organise and synthesise the data. This (deductive) approach to qualitative analysis allowed for a more structured approach to data collection based on the pre-determined aims (to assess the acceptability of the intervention and the design and trial processes). Phases of analysis included familiarisation with the data, generating initial codes, searching for predetermined themes, reviewing the themes and generating a thematic map. Software (NVivo version 11; QSR International, Warrington, UK) was used to code and organise the data within a thematic matrix. The matrix was populated with the pre-determined themes as column headings and relevant data from each case in the corresponding rows. Finally, a thematic map of the factors influencing acceptability and suggestions for improvement was generated. Initial analysis was undertaken by the lead qualitative researcher (AE) and further refined through presentations of the analysis/discussion with the other interviewers [Harminder Kaur, CD and the chief investigator (EH)] for feedback/critique.

Baseline characteristics

Participant characteristics at baseline are shown in Table 5. The average age was 44.8 years, ranging from 22 years to 66.1 years. There was almost an equal split of men (48.6%) and women (47.2%); three participants stated that they were ‘other’, describing themselves as intersex, unable to select one answer, or not providing information. The majority of the participants classed themselves as heterosexual (81.9%), with four stating they were gay or lesbian (5.6%), six saying bisexual (8.3%), one participant preferring not to say and two responding ‘other’. Of the two that responded ‘other’ regarding their sexuality, one was unsure and one stated they were pansexual. Forty-six (63.9%) of the participants in the RESPECT study were white British; however, the other 36.1% of participants were from a wide range of ethnic backgrounds (see Table 5).

Similarly, there was a wide range of religious beliefs represented in the trial participants. The most common was Christian (37.5%), or no religion (40.3%). However, the trial participants also included six Muslims (8.3%), one Sikh (1.4%), three Buddhists (4.2%), one participant preferring not to say (1.4%), and two (2.8%) stating that they had other beliefs.

The level of qualifications varied from six participants having no qualifications (8.3%), to seven participants having further higher degrees (9.7%). The most common level of education was AS (Advanced Subsidiary) level/A (Advanced) level and higher degrees, both having been completed by 12 participants (16.7%), with GCSE (General Certificate of Secondary Education)/GCE (General Certificate of Education)/CSE (Certificate of Secondary Education) having been obtained by 11 participants (15.3%). Over half of the participants in the trial were currently unable to work because of poor health (52.8%) and 13 were unemployed (18.1%). Of those that were currently in work, six were working full time and seven were working part time. Three participants (4.2%) were retired and three (4.2%) were students.

The majority of participants stated that they were living alone (58.3%), others were living with their parent/carers (15.3%), other relatives (5.6%), friends (4.6%) or their partner/spouse (8.3%). Three participants were living in hostels, and two had other living arrangements (one living in a house of multiple occupancy and the other in a supported living facility).

Recruitment rates

Over the course of 12 months, 138 people were screened. (This is based on data from the screening log. There is a larger proportion of people identified informally as eligible and packs were given to care co-ordinators or posted out; however, we were unable to get accurate information regarding how many of those potentially eligible people actually received the packs.) Of these 138 people, 117 people met the defined eligibility criteria for inclusion in the trial. This figure of 84.8% eligible people is much higher than the 50–60% anticipated. 35,41 Of these, a total of 72 participants were randomised into the trial (March 2017 to January 2018), giving a recruitment rate of 61.5% (from which 52.2% of screened participants then went on to enter the study), again higher than the 40% which was predicted (Figure 4). The flow of participants can be seen in Figure 5.

FIGURE 4.

Recruitment graph for the RESPECT trial from March to December 2017 (by centre).

FIGURE 5.

The CONSORT flow diagram. a, Reasons for not meeting inclusion criteria are not mutually exclusive; b, this eligibility criterion was dropped after 27 April 2017.

These 72 participants were recruited from the six sites, with LYPFT and C&IFT recruiting the majority (70.8%) of the participants, 24 and 27, respectively. The remaining 21 participants were recruited from SWYFT (n = 8), NELFT (n = 7), SPFT (n = 4) and the Community Links – aspire service (n = 2).

Retention rate

Completion of data

Completion of standardised measures

The details of the completion of the standardised measures can be found in Table 6. The percentages are given out of those who completed the relevant time point interview. These completion rates do not account for the attrition rates of the trial and, as such, represent the completion of the returned questionnaires. This is so that the standardised measures can be assessed for suitability for use as a future primary outcome, rather than assessing the level of attrition in the trial. For those measures in which there was no fixed scoring mechanism, or when not all questions were applicable to all, the completion rate is taken as a response to any element of the questionnaire.

Overall, the standardised measures were all completed, with minimal missing data. There was also no visual difference in the completion rates between the treatment arms.

Sexual and risk behaviour measures

The SERBAS is a measure that is split into two separate questionnaires, one to be completed by males and one by females. Of the three participants who classified themselves as another gender, two completed the female version and one completed the male version. It is not known if the participant or the researcher selected which version to complete.

The main focus of the SERBAS in the RESPECT trial was quantifying the proportion of sex acts that were undertaken without any form of protection, with the hope that the intervention may influence this. Table 9 details the proportion of all sex acts (vaginal, oral and anal) that were undertaken without protection, within the last 3 months at each time point, overall, by treatment arm and by gender. Full details on the results from the SERBAS can be found in Tables 24 and 25 in Appendix 2.

It can be seen in Table 9 that there is a high level of unprotected sexual acts occurring in the participants in the RESPECT study. However, it should be noted that there were participants in the study that were not sexually active over the course of the study. At baseline, only 20 participants who completed the female SERBAS (55.6%) and only 10 participants (27.8%) who completed the male SERBAS had undertaken any sexual act within the previous 3 months.

Within the RESPECT study there was almost no sex trading reported. At baseline, two participants reported having paid for sex once and that they had not used condoms on these occasions. At 3 months, a different participant reported having paid for sex once and did use a condom, and at 6 months one participant, who had also done so at baseline, reported that they had paid for sex three times and did not use a condom on any occasion. All of the participants who did not use a condom were in the control arm, and the participant who used a condom was in the intervention arm. Only one participant reported an episode of forced sex, which had occurred once. At the point of disclosure during the administration of the SERBAS (as per protocol) the researcher asked the participant if they had someone to discuss this with and they replied that they were discussing the incident with their care co-ordinator and it was being dealt with, and that no action or further support was required from the RESPECT study team. The chief investigator was informed of this and approved no further action.

From Tables 24 and 25 in Appendix 2, it can be noted that the female participants in the study reported having more vaginal sex than the men at baseline: an average of 37.3 times in the last 3 months for women, with 58.4% of that not involving condom use, compared with an average of five times for men, with 81.4% of that being unprotected. This gender difference continued at 3- and 6-month follow-up. It can also be seen that very few participants in the study reported having anal sex, but that almost all of the acts were undertaken without condoms. Similarly the majority of the oral sex (both participant on partner and vice versa) was reported as being undertaken without protection, despite a substantial amount of oral sex being reported. In this instance, protection could be either condoms or dental dams dependent on the gender of the participating people.

Participants were asked to select up to three reasons for not participating in sexual activity with male and with female partners in the last 3 months; not all participants utilised the possible six reasons. The majority of participants were not interested in having sex with a same-sex partner (n = 55) but the other reasons given (as frequencies) are as follows:

• no current partner (n = 27)

• participant not interested in sex (n = 10)

• participant’s mental illness/medication side effects (n = 9)

• not interested with opposite sex partner (n = 4)

• participant’s illness or fatigue (n = 3)

• lack of privacy (n = 3)

• partner not interested in sex (n = 3)

• partner died (n = 2)

• partner’s mental illness/medication side effects (n = 1)

• participant’s drug use (n = 1)

• other reasons included: no opportunity (n = 2), does not trust women (n = 1), having to ‘fend off’ harassers (n = 1), religious reasons (n = 1), last partner cheated (n = 1), not looking for partner (n = 1), currently separated from wife (n = 1) and one participant gave no additional information.

Natsal-3

Elements of the Natsal-3 questionnaire were used within the RESPECT study. The results were similar across all three time points and the full details can be found in Table 26 in Appendix 2. One of the main areas covered by questions from the Natsal-3 questionnaire included contraception use. The male condom was found to be the most popular contraception method currently used, with 74.3% of men and 97.1% of women reporting using it as one of their most usual methods at baseline. Contraception was mainly obtained from health-care professionals (including doctors, or staff in pharmacies and sexual health clinics) and this was also found to be the favoured way to obtain contraception if participants had the option. Over half of the participants had visited a sexual health clinic, but most had not visited in the last year. Most participants had never been told that they had had a STI, and of those who had, chlamydia and genital warts were the most commonly reported STIs. Forty-two of the participants (58.3%) had been tested for HIV at some point, mainly as part of a sexual health check-up or because of concern for their own safety. For most of the participants this test was over 5 years ago, but eight participants (19.1%) had had a HIV test in the last year.

Knowledge about human immunodeficiency virus

The HIV-KQ consists of 18 questions, with a ‘yes’, ‘no’ and ‘don’t know’ option, meaning an average correct score can be calculated. Within the RESPECT study, only 17 questions were asked as it was felt that one of the questions, ‘A natural skin condom works better against HIV than does a latex condom’, was outdated and possibly confusing. The results are given in Table 10.

At baseline, the average score was 67.3% correct; this equates to between five and six incorrect answers on average. No one knew the answers to all of the questions and one person did not get any of the questions correct. The average score was similar in the two arms: 68.8% for the intervention arm and 65.9% for the control arm.

At 3 months, the average score had slightly increased (to 70.7%), equating to an average of five questions answered incorrectly. The average score was slightly different between arms: 75.7% for the intervention arm and 65.3% for the control arm. However, three participants now answered all questions correctly (two in the intervention arm and one in the control arm) with two participants answering all questions incorrectly, both from the control arm.

Despite the reduced number of participants who had data collected at 6 months, the results seen at 3 months still hold. The average score was 71.6% (74.3% for the intervention arm and 68.8% for the control arm). However, at this time point no participant received a score of 0.0%.

The most commonly incorrectly, or unknown, answered question was ‘All pregnant women infected with HIV will have babies born with AIDS’.

Motivations to engage in safer sex scale

The motivations to engage in safer sex scale consists of four questions asking how much risk the participant believes they are at of getting a STI, the chance of ever getting a STI, how big a problem STIs are in their community and whether or not they are worried about getting a STI. The majority of participants answered all questions in the ‘Somewhat at risk’ to ‘No risk at all’, with proportions staying constant across time points. One exception to this was the final question at month 3, which had an unexplainably large number of missing data (n = 33 of 59, 55.9%). Full details of the results can be found in Table 27 in Appendix 2.

Condom Use Self-Efficacy Scale

The Condom Use Self-Efficacy Scale is detailed in Table 11, and the results for sections one and two independently can be found in Table 28 in Appendix 2. The results between baseline and month 3 do indicate a slight rise in condom efficacy that drops slightly at month 6, but this may be explained by the reduced sample size. The Condom Use Self-Efficacy Scale was one of the least completed measures in the RESPECT trial (see Table 6 for completion rates); however, this is most likely to be because of the missing data mechanism used within this measure, in which only one item from each section could be missing and a score still calculated.

Behavioural Intentions for Safer Sex

Scored from 0 to 40, the Behavioural Intentions for Safer Sex measure indicates the level of intention a participant has to have safe sex, with higher scores indicating more intention. Table 12 details the scores by arm and overall, at each time point. In Table 12 it can be seen that there is minimal change in the responses across the time points, but that it increases slightly for the intervention arm and that there is a slight decrease in the control arm.

The Mental Illness Stigma Scale

Details of the results of the questions of the MISS-Q at each of the three time points can be found in Table 29 in Appendix 2. These results are given with the count and proportions who agreed with the statements, those who did not answer the question, and those who said that it was not applicable to them. One of the questions, which asked about protecting oneself or one’s partner from getting pregnant, has a larger than normal proportion of ‘N/A’ (not applicable) responses, which is because the question was printed incorrectly; it asked about protecting oneself from pregnancy and thus was not answered by most male respondents. At baseline, the statement with most agreement was ‘You are the one who chooses the course of your sexual life’ with 76.4% agreement overall. The statements with the least agreement were ‘Often a mental health provider has said you should not have a romantic or sexual relationship with people who do not have a mental illness’ and ‘Often a mental health provider has said you should have a hysterectomy, etc. as a form of birth control’, both with 0% agreement.

Alcohol, Smoking and Substance Involvement Screening Test

The ASSIST calculates risk scores for a set list of substances. The majority of the participants in the RESPECT trial were in the ‘Low risk’ category for all substances except tobacco, for which the majority of participants were categorised as at ‘Moderate risk’. These results were consistence across all three time points in the study. Table 13 details the total substance involvement scores, where the lower the score the less involvement the participant has had with any substance. The overall levels stay similar across the three time points. It can be seen that there are some participants who had no involvement with any substances (a score of zero) and some who had extensive involvement.

Full details of the results of the ASSIST, including the breakdown of individual substances scores, can be found in Table 30 in Appendix 2.

Recovering Quality of Life

The ReQoL is a measure that looks at the quality of life of the participants, scored from 0 to 80, with a higher score indicating a higher quality of life. A score of < 50 is defined as characteristic of a clinical population. At each time point, the mean and median scores for the ReQoL were both < 50 (as detailed in Table 14), inferring that our population is typical of mental health service users. At baseline there were 42 participants (58.3%) with a score of < 50 (19 in the intervention arm and 23 in the control arm), at 3 months this was 36 participants (61.0%) (16 participants in the intervention arm and 20 participants in the control arm) and at 6 months it was 17 participants (58.6%) (eight participants in the intervention arm and nine in the control arm).

Data completion

The questionnaire response rate was based on completion of at least one resource use item (including zeros). Table 15 shows that the number of respondents who completed at least one item of the resource use questionnaire was 36 (100%), 30 (83%) and 13 (36%) at baseline, 3 months and 6 months, respectively in the intervention arm. The response rate was comparable in the control arm with 36 (100%), 26 (72%) and 15 (42%) respondents completing the questionnaire at baseline, 3 months and 6 months, respectively. Moreover, this was similar to the overall questionnaire completion rate in the study.

Table 15 also shows that the rate of missing items in the resource use questionnaire was very low. Response to an item was considered missing if response to the binary (yes/no) question about a service use item (such as GP consultations) was missing or the number of visits conditional on a ‘yes’ response was missing. In the intervention arm, one response was missing at baseline for GP consultations, A&E or urgent care visits and pharmacy visits. In the control arm, three responses were missing for pharmacy visits and one each for nurse and sexual health clinic consultations. Overall, there is a slightly higher number of missing values for pharmacy visits; however, overall the number of missing responses remained low.

Frequency and reasons for health service use

Table 16 shows the frequency of use of each type of health service in the last 3 months. Given the small number of respondents (particularly during the follow-up), the aim of this section is to summarise the results rather than draw a statistical inference of a difference between groups or patterns of service use over time.

At baseline, GP and nurse consultations were most common in both the intervention arm and the control arm, with 77.8% and 63.9% of respondents reporting at least one consultation with a GP or a nurse, respectively, in the intervention arm. The figures were similar in the control arm at 80.6% and 66.7% of respondents with a GP or nurse consultation, respectively. Moreover, the mean number of consultations for those who consulted was also similar in the two groups at baseline. During the follow-up period, the proportion of patients with GP or nurse consultations reduced over time at a similar rate in both the intervention and control groups, except at the 6-month time point when a higher proportion of respondents in the control arm (80%) had at least one nurse consultation than in the intervention arm (69%). However, given the small number of respondents at the 6-month time point, any statistically meaningful conclusion cannot be drawn.

Table 17 presents a summary of sexual health-related reasons for consultations for those who had at least one consultation (note: this may include more than one consultation by the same patient). For GP consultations, the two most common reasons for consultations at baseline were ‘to get advice for discharge through vagina, penis or anus; or sores in genital area; or pain when passing urine’ and ‘to get the morning-after pill or to discuss contraception or family planning’. For nurse consultations, a small number of visits were related to sexual health, with the two most common reasons being ‘to get tested for HIV, hepatitis or other STIs’ and ‘to discuss other sexual health issues not listed, including sexual assault’.

Table 16 shows that, at baseline, a higher number (and proportion) of usual-care respondents (9 respondents, 25%) had at least one A&E or urgent care centre visit which was higher than the figure in the treatment arm (4 respondents, 11%). During the follow-up, the number of A&E (and urgent care) visits reduced over time in both arms. However, more importantly, none of these visits at baseline or at follow-up time points were related to a sexual health reason (see Table 17).

Pharmacy visits or appointments were few in both groups at baseline as well as at follow-up time points. The use of contraception clinics was low in both groups, with only three respondents using them in the intervention group at baseline, reducing to one and none at 3 and 6 months, respectively. Only one respondent in the control group used the service at 6 months. This, together with other responses related to accessing contraception, suggests that respondents were more likely to get contraception/family planning advice or the morning-after pill from a sexual health clinic or their GP than from a contraception clinic.

Sexual health consultations were relatively high at baseline in the intervention group (6 respondents, 16.7%) compared with the control arm (one respondent, 2.8%). These consultations reduced over time in the intervention group and remained low in the control arm. The most common reasons for consultations at a sexual health clinic were ‘to get tested for HIV, hepatitis or other sexually-transmitted infections’ and ‘to get the morning-after pill or to discuss contraception or family planning’. The use of the Sexual Assault Referral Centre (SARC) was also very low, with only one respondent each in the intervention and control arms using the service at baseline and no respondents using it at follow-up.

Unit costs of health service use

Unit costs were obtained from national databases, when available, and otherwise from other published sources. Sources of and assumptions for unit costs are presented in Table 18.

Intervention cost

The intervention consisted of up to three 1-hour sessions of sexual health promotion delivered by a trained mental health worker. These sessions delivered specifically designed training material. A total of 25 participants attended at least one session, 19 attended two sessions and 17 attended all three sessions (see Table 18). However, in some cases (n = 5) based on participants’ preference, a ‘combo’ session was delivered that covered material for more than one session, which reduced the number of sessions required/attended.

The duration of the three sessions was similar, with the mean being 59.2 minutes for the first session and 57.1 and 57.8 minutes for sessions 2 and 3, respectively (Table 19). This is in line with the time allocated for these sessions (i.e. up to 60 minutes per session). The duration of the combo sessions was longer with the mean being 93.8 minutes. There was some variability in the length of sessions, which is clear from the minimum and maximum values.

Data were also collected on the proportion of the training material covered across all sessions by each participant who attended at least one session. This was used to estimate the total time required to deliver the full material to each participant; for example, if two-thirds of the material was covered in two sessions lasting 55 minutes each, then the estimated time to deliver the full material for this particular participant would be 165 minutes. Based on this approach, the estimated mean time to deliver the full training material was 170 minutes (range 101–307.5 minutes) (see Table 19). This was then multiplied by the hourly rate of a mental health worker (who delivered these sessions) which is £39 per hour (see Table 19). Based on this, the estimated mean cost of delivering the training material was £110.50 (range £65.70–199.90). However, it should be noted that the maximum value represents one outlier participant with one long (non-combo) session and excluding this participant changes the maximum cost to £146.

In addition to the cost of delivering the intervention, we considered the cost of training the interventionists (mostly, mental health workers). This included two components: (1) the time cost of the interventionist and (2) the time cost of the trainer. The training log (see Table 22) shows that the training was delivered over 1–2 days and each training session had between one and four participants. Overall, 21 people working in the mental health services received training to deliver the intervention. Initially it was delivered over 2 days but in the later stages it was condensed into 1 day. Overall, 16 training days were delivered by the study team. Assuming a full day equals 8 hours, and using the hourly wage of £39 for mental health workers, the estimated time cost for the interventionist to receive the training was £237.70. Regarding the second component of the training cost, we assumed that in practice the training will be delivered by a mental health worker (although during the project the training was delivered by the principal investigator of the research project). As a result, the total cost of delivering the training, including the time cost of the interventionist as well as the trainer, was equal to £475.20. Because this is a one-off cost, it was not added to the intervention delivery cost. Finally, although all the professionals providing the training were offered the option of using supervision support, none of them used this option.

Total cost of health service resource use

Figure 6 presents the total health services resource use cost in the last 3 months, by intervention arm and time point. This does not include the intervention cost. At baseline, resource use cost was slightly higher in the control arm than in the intervention arm: this is partly because of a higher number of A&E visits in the control arm than in the intervention arm. Health services costs reduced over time in both the intervention arm and the control arm, with costs in the control arm being higher than in the intervention arm at the 3-month time point and lower at the 6-month time point. These figures should be interpreted with caution because of the small number of respondents, particularly at the 6-month follow-up (at 6 months, n = 13 in the intervention arm and n = 15 in the control arm).

FIGURE 6.

Health service resource use cost (excluding the intervention cost), by time point.

Health-related quality of life

Frequency and pattern of EQ-5D item responses

Figure 7 presents the distribution of completed responses to each domain or item of the EQ-5D questionnaire at baseline and at follow-up in the intervention arm. For mobility and self-care domains, over 70% of respondents in the intervention arm had no problem or slight problems at baseline and follow-up. However, there was a small shift in mobility from moderate problems at baseline and 3 months to improvement (slight problems) or worsening (severe problems) at 6 months. For the self-care domain, there was a small improvement over the follow-up period in the intervention arm, which was observed as a reduction in severe problems. For the usual activities domain, just over 50% of respondents in the intervention arm reported having some level of problems. There was a small improvement in usual activities at 6 months with no respondent reporting severe or extreme problems. For the pain and/or discomfort item, just under half of all respondents in the intervention arm reported having some level of problems at baseline. Over the follow-up period, the proportion of respondents with severe problems reduced but at the same time there were fewer respondents with no problems. Finally, for the anxiety and/or depression domain, most respondents in the intervention arm reported having some level of problems; however, there was a small improvement during the follow-up in terms of a reduction in respondents with severe or extreme problems.

FIGURE 7.

The EQ-5D responses at baseline (BL), 3 months (3M) and 6 months (6M) for the intervention group.

Figure 8 presents the distribution of completed responses to EQ-5D domains at baseline and follow-up in the control arm. Approximately 90% and 80% respondents in the control arm had no problem or slight problems at baseline on the mobility and self-care domains, respectively. This suggests that the control arm was slightly healthier at baseline than the intervention arm. The same was true for the usual activities, pain/discomfort and anxiety/depression domains at baseline. During the follow-up period, the mobility, self-care and pain/discomfort domains had minimal change but there was an increase in slight problems in the usual-care activities domain at 6 months compared with baseline. Finally, there was an increase in the percentage of respondents with no problems as well as those with moderate problems in terms of anxiety and/or depression.

FIGURE 8.

The EQ-5D responses at baseline (BL), 3 months (3M) and 6 months (6M) for the usual-care group.

Health-related quality of life (utility values)

Figure 9 compares utility values for the 22 patients who completed three sessions of the intervention with the control arm. The figure shows greater improvement in utility value in the intervention arm than for usual care, and also than for the overall intervention group. However, as with the cost data, these results should be interpreted with caution as they represent only the complete cases and a small sample size. Moreover, the intervention group in Figure 9 represents a selected group who underwent the maximum number of sessions and may not represent the overall target population. This is in line with Figures 7 and 8, which also showed a slightly bigger improvement in quality-of-life domains in the intervention group than in the control group.

FIGURE 9.

Utility values based on EQ-5D-5L responses at baseline, 3 months and 6 months for the treatment (those who completed three sessions) and usual-care groups.

South West Yorkshire Partnership NHS Foundation Trust

In the SWYFT, the study was only opened to recruitment in one locality (Barnsley), as this was the location of the staff who had been trained to deliver the study intervention. Participants were recruited from three core teams and the early intervention team. At the start of the study period, all the teams were using the care model of Assertive Outreach and Community (AOT) mental health teams. An initial approach was made to the AOT staff and 51 potentially eligible service users were identified. Study packs were given to staff to pass on to those service users at routine appointments. This only yielded one service user, who expressed a tentative interest but later declined to participate. However, it was difficult to assess how many of the packs had actually been given out to service users, and the monitoring form that was given to the CMHTs was poorly complied with. The remainder of those service users identified as eligible (n = 149) had information packs mailed to their home address. In total in SWYFT, eight people consented to participate and the vast majority were recruited via the mail-out method. One person at this site was recruited via a clinic visit by research staff.

Overall, giving study information to clinical staff for them to pass on to service users was unreliable and yielded no recruits at this site. The optimal approach at the SWYFT was posting the information and then doing a callback after a week or so. The research staff also recommend taking advantage of all available communication resources, for example using the trust service directory, asking team leaders to circulate information and promoting research on the trust’s electronic weekly newsletter. It has been useful for CSOs to base some of their working day at the CMHT hubs as those more informal conversations can be really useful in keeping research studies on the agenda. These are also places where service users attend appointments, so it was useful to maintain contact, have conversations and disseminate new study information.

Leeds and York Partnership NHS Foundation Trust

The LYPFT was the second best recruiting site and recruited 24 participants to the study. In terms of what went well, attending multidisciplinary team (MDT) meetings to talk about the study was identified as useful and it was felt even more useful if the study researchers were also able to attend those meetings. Attendance at these meetings allowed for preparatory work and conversations to occur prior to recruitment. As the recruitment period progressed, it was also useful to maintain a regular presence at the MDT monthly meetings during the recruitment phase. In addition to targeting the MDT community teams, LYPFT engaged with the psychiatrists. Although screening psychiatrists’ caseloads could be time-consuming, it ensured that all eligible service users received an invitation pack. The mail-out recruitment method seemed to work best for those people on psychiatrists’ caseloads as they see service users less frequently. As well as attending the MDT meetings, having face-to-face meetings with specific care co-ordinators was useful in terms of being able to properly discuss the aims of the study and eligibility criteria. Attending service user groups and mental health day centres, and talking to service users directly, also proved useful as they had the opportunity to ask questions, to express concerns and for discussion of those concerns. Staff mentioned that they felt that the recruitment packs contained too much information and that this was off-putting for both staff and service users. Because staff do not usually have e-mail contact with service users, sharing social media links or videos (YouTube videos about the study) (YouTube, LLC, San Bruno, CA, USA; www.youtube.com) was difficult through this medium, as was the use of social media to promote the study.

Camden and Islington NHS Foundation Trust

The C&IFT was the top recruiting site, with a total of 27 participants. The R&D team initially presented to teams (mainly rehabilitation and recovery teams) and obtained a couple of referrals from clinicians after these presentations. In addition, the team used the mail-out recruitment method and conducted some follow-up calls, resulting in a couple of CtoC forms. However, the majority of participants were recruited through making a direct and personal approach. This included the RESPECT study researcher attending the waiting rooms of clozapine and depot clinics (this resulted in 14 CtoCs being completed, which resulted in the recruitment of seven participants) and in the waiting room of one outpatient mental health service (which resulted in 12 CtoCs being completed, from which six service users agreed to participate). Ringing patients on the caseloads of psychiatrists from one locality resulted in 17 CtoCs being completed and 12 participants. The psychiatrists in the local recovery team have large caseloads of outpatients (in some cases > 200), so this proved a quick and effective method of reaching people.

Sussex Partnership NHS Foundation Trust

The SPFT recruited four participants. In this trust, when patients are first registered they have the option to opt-in to research; therefore, mail-outs and follow-up calls were made to participants who had opted-in and were potentially eligible. Attempts were made to engage with community mental health groups but the trust closed as a recruiting site for the RESPECT study early (because of a lack of staff resource to deliver the intervention) before these links could be fully established.

North East London NHS Foundation Trust

This site began recruiting in the autumn of 2017 and, despite a late start and being open for only about 8 weeks, it was able to recruit seven participants. Like SPFT, NEFLT also operates an opt-in to its research scheme, which means that all service users are asked to give permission to be contacted about studies that they may be eligible for by the R&D team as part of routine care. Using this opt-in list, NELFT was able to mail out study information to those on the list, targeting people who use the early intervention services and community recovery teams, and then make follow-up calls 2 weeks later. This method yielded all seven recruits within a few weeks of opening.

Recruitment stage feedback questionnaire

A total of 158 completed feedback questionnaires were received. Most respondents felt that they understood what the RESPECT study was about (62%, n = 98) and they agreed that others with similar needs would benefit from the study results (59.5%, n = 94). Regarding the question on randomisation, only 15.8% (n = 25) agreed that they felt ‘worried’ about this aspect of the study, although the majority of people who answered this question disagreed with the statement (41.7%, n = 66). Overall, respondents did not feel that participation would be difficult because of practical reasons, with only 10.1% (n = 16) agreeing that this was an issue.

Almost one-third (27.2%, n = 43) of participants identified things that had helped them make their decision about whether or not to participate, including their desire to learn more about sexual health and previous concerns about sexual health (having had a STI in the past). Some mentioned that the PIS and other study materials had helped them to make the decision to participate. Some people stated that they wanted to take part in research as they wanted to contribute to mental health research. Other reasons to participate included flexibility in how appointments could be offered, the positive manner of the researchers and being able to talk through the study with family and/or staff.

Reasons some people declined to take part

Of those who completed the questionnaire, 42.4% decided not to take part (n = 67). The most frequent reason for declining was feeling that the topic was of no relevance to them. The specific reasons for it not being relevant included not being sexually active (n = 15), being in a stable relationship/not having casual sex (n = 10), being ‘too old’ (n = 9) and feeling that they had enough knowledge already (n = 4). Other reasons for declining included not wishing to discuss sexual health (n = 15) and not feeling comfortable with discussing the topic of sexual health (n = 9).

Only two responses related specifically to the study design/process: being put off by the time commitment for the data collection (the PIS stated that it could take up to 2 hours). Finally, six responses related to time pressures and commitment to the study as a whole.

Approximately one-third of respondents (30.4%, n = 38) provided further comments about the study. Generally there was support for the study, and even some people who had decided not to take part expressed the view that the study was a ‘good idea’ and that they were pleased that the ‘elephant in the room of psychiatry’ was finally being discussed.

Assessment of recruitment strategies used

The opening question asked participants how they found out about the study and the responses indicated that the participants had been recruited via a range of recruitment strategies. These included through face-to-face conversations with their keyworker, receiving a letter through the post from their care co-ordinator, being handed an information leaflet during a visit to a clinic (by the research team), seeing the trial poster/leaflet in a clinical area and attending a day centre presentation by the research team.

Although none of the participants expressed disapproval about particular methods, there was a clear theme of preference for a conversation as well as receiving information. For example, one participant (who had received study information by post) talked about the difficulty she has in opening her mail, as well as being able to read detailed information and then responding to the mail:

I think probably inform people’s care co-ordinators, just in general, just say OK, you know, we have a research study, just inform your clients you know, because a lot of people don’t reply to post and a lot of mental health service users, I know for me, sometimes I don’t want to open my mail.

Participant 22, female, intervention

Another participant, who also received information by post, felt that he would have liked a prior conversation with a member of staff:

. . . my co-ordinator . . . they could have let me know beforehand . . .

Participant 3, male, usual care

A participant who had found out about the study from their care co-ordinator suggested that this method was suitable and a good way of approaching others. Other participants described it as a useful approach because they saw their nurse often and it offered an opportunity to ask questions.

Other suggested ways to promote the study included promotion via the radio, social media postings from mental health charities and sexual health services, leaflets via their GP and through inpatient hospital settings (specifically approaching service users).

There were also some comments about the volume of information received (study pack). It was suggested that initial written information should be brief (leaflet, social media posting) or the study pack should be handed out with a verbal discussion:

Tell them verbally, I mean obviously you can’t go around to everybody individually and say can you take part in our study, but telling departments in mental health services, telling people at [facility name redacted], you know, pass these along to your clients, because like I said, a lot of people don’t open their mail, or they’re not well enough to be able to, you know, read or want to understand what’s going on and sometimes, I know for myself, I’ve missed opportunities like that. When I think of it now, I kind of think well I could have actually gone for it if I did probably sit down, but then someone would still need to have been able to reiterate that to me and explain it to me.

Participant 22, female, intervention

In thinking about how a future study could optimise recruitment, participant 22 suggested a more graduated approach to information giving during the recruitment phase.

The face-to-face (and/or telephone) conversations about the study were really valued and helped people to understand the study better and make informed decisions to take part or not.

Acceptability of the participant information sheet

Participants were asked to recall and express their opinion of the PIS used in study. Participants were prompted to think about the amount of information and the readability.

Most could recall the information sheet and described it as easy to understand, with enough information. One participant described it as:

Informative without being boring.

Participant 17, female, intervention

However, five of the participants described the PIS as being ‘too much’: too much information, reading and paperwork. Some participants suggested that we simplify the language for future use. One participant expressed the view:

I was really struggling to be honest, getting to read past the first two lines [Interviewer: Right]. I think it’s probably my mental health that’s affecting me.

Participant 11, female, usual care

Acceptability and understanding of randomisation

During the interview, participants were asked to recall the process of randomisation (a prompt was offered) and offer their view:

You might recall the randomisation process – where all participants were put into one of two groups: ‘sexual health intervention’ or ‘usual care’. A computer chose which of the two groups people went into. What did you think about that?

Interviewer

Most of the participants (n = 17) could recall the process of randomisation and described the process as ‘good’ and ‘fair’:

I think that’s a fair way of doing it, yep, that was, you know, randomisation, is, it’s the only way really to do something like that, so that was fine with me.

Participant 13, female, usual care

I don’t mind it randomised, as long as it helps you guys choose the best option for me.

Participant 20, male, usual care

Four participants were unable to recall the randomisation process at all and four expressed some confusion regarding the purpose and the process of randomisation:

I’ve got to be honest, I didn’t really understand it and I’m quite bright but it was, it kind of, it’s either yeah, it was convoluted.

Participant 6, female, intervention

I felt a little bit anxious not knowing which group I’ll end up in.

Participant 11, female, usual care

However, overall, most had found the process of randomisation an acceptable feature of the trial.

Acceptability of the data collection procedure

Participants were asked to give their view on several features of the data collection procedure, which included their experience of meeting the researcher, the location, the duration, the research questions, and the payment for their time (£10 voucher). Each of these will be discussed separately.

Acceptability of the intervention content and delivery

Most of the participants (n = 12, intervention) positively recalled the content and delivery (including location and duration) of the intervention sessions. Participants’ responses captured how the intervention not only covered ‘helpful’ content, but it also provided a ‘human face’ and a space/service to talk about sex and relationships and the associated affective experiences:

Kind of more natural, it wasn’t just a questionnaire, you know, we had practising putting on a condom and I actually showed him how to put one on, but, you know, it was nice, you know, it was sort of the human face of it really.

Participant 6, female, intervention

I actually need to talk about this [a previous sexual relationship] because it’s to do with sex and there wasn’t any sort of provision for like, you know.

Participant 6, female, intervention

It was quite good though, to talk about, you know, relationships and how they affect you.

Participant 21, male, intervention

It was very good, it was good to express myself.

Participant 19, female, intervention

The different features of delivery (i.e. arranging the sessions, the interactive and practical elements, the location and duration) were all acceptable. Participants experienced the intervention at their home or in a local clinic and both locations were described as ‘good’ or ‘comfortable’.

The sessions were described as ‘relaxed’, ‘helpful’, ‘interactive’, ‘informative’ and ‘an education’:

The quizzes were, were good, some things were kind of obvious, but some things weren’t, you know. I didn’t know stuff about AIDS that I really should know and things like that . . .

Participant 6, female, intervention

They were quite informative and they used these little sort of laminated sort of pieces of paper and moved those around a lot and so it, it’s a good technique to talk about things and you get to sort of think about things.

Participant 15, female, intervention

They [the sessions] were quite relaxed, just took place in like a room, he, it was like quite interactive, which is good . . . it was really educational and good. I felt quite comfortable doing it.

Participant 17, female, intervention

All of the participants felt that the length of session (1 hour) was acceptable and allowed enough time to cover the planned materials. Only one participant suggested that an extra visit(s) might be useful:

They’re [the sessions] not a bad length, because there’s enough time to cover quite a lot. I found that we kind of covered, for the first two or three, we kind of covered everything a little bit quicker, because like I said, its, I had some knowledge of it myself anyway. But then obviously when we started getting into things like the STIs and the stuff like that, then it possibly could be, not a bit longer, say an extra one or two visits, just to cover them and go into a bit more depth.

Participant 4, male, intervention

Other participants suggested improvements focused on content, for example more information on how to use (and where to find) the female condom and spending more time discussing assertiveness in relationships:

There were a lot of questions and you know, testing your knowledge and that and it wasn’t so much that I were lacking, its more assertiveness in relationships that I lack, you know what I mean.

Participant 2, male, intervention

I asked these things, can you show me how to use a female condom and she answered well we don’t have any, it’s not something that was catered for very, very well.

Participant 22, female, intervention

Other comments about the trial and suggested improvements

Given the sensitive nature of the trial, we were very interested to find out the reasons participants chose to take part and whether or not they had any initial (or ongoing) concerns.

Suggested improvements

The participants suggested that a number of areas of the study and the intervention that could be improved. There were some suggestions that the researchers should be the same gender as the participant (or at least have the choice). They also suggested that recruitment could be targeted towards people who are ready to be discharged from hospital. In terms of recruitment, they recommended keeping a range of methods but also having a face-to-face conversation or telephone call to assist in understanding the study information:

The one thing I thought was quite odd was, or what could be improved could maybe to be able to choose the gender of the researcher. Not because I had any problem with her being a female kind of interviewer, but I just, if it had to be something that I felt odd about, it would be the, yeah, automatically female interviewer, was one area where you could maybe have a choice.

Participant 14, male, usual care

In terms of the questions, more clarity in relation to the number, type, content (and purpose) of the questions is recommended:

If I was doing the survey myself, I probably wouldn’t have asked as many questions.

Participant 10, male, usual care

Some of the questions were also considered a little ‘outdated’. For example, the addition of a ‘friends with benefits’ category (in the demographic information section) and legal highs [in substance use questionnaire(s)] was also suggested:

The family has changed in the last decade and also women have as well and we, you know, just completely different roles isn’t it. Yeah, I did find myself in a situation, I wouldn’t say it’s something that I, but yeah, it should be put in a box, do you have a friend with benefits, rather than saying are you in a relationship.

Participant 8, female, intervention

I think just include kind of legal highs or so-called research chemicals, I think you kind of stuck mostly to, you know, the traditional drugs that most people know about [I: Right OK]. But actually a lot of people nowadays in particular as well, young people are ordering drugs from the internet or may have taken legal highs or drugs that were legal highs at one point but are now illegal.

Participant 14, male, usual care

Suggested improvements to the intervention included more of a focus on assertiveness and more information about female condoms (how to use them/where to access them), as mentioned previously in Acceptability of the intervention content and delivery.

Feasibility parameters and decision to progress to a definitive randomised controlled trial

Progression criteria for a definitive RCT were not predefined, but the aims of the study were to establish the following:

• whether or not sufficient numbers of eligible people consent to participate (recruitment)

• whether or not sufficient numbers of participants attend follow-up appointments and complete the questionnaires (retention)

• the completeness of the outcome measures at each time point

• whether or not the intervention, study processes and design were acceptable.

A future trial would expect to recruit at a revised rate based on the recruitment information that we have (see Chapter 5, Possible future sample size) and retain at least 70% of participants at follow-up time points.

Numbers recruited

In the RESPECT study, the target sample size was 100 as this has been deemed an optimal number required for the calculation of future sample size;45 this was accounting for an estimated 30% to give an analysable sample of 70. Unfortunately, the target of 100 participants was not met, with only 72 participants being randomised into the trial. Owing to this, and the extension to recruitment, only a subsample of participants (n = 29) completed the 6-month follow-up, making the robustness of a SD, and thus a sample size, questionable.

This was a feasibility study and there was limited information from which to plan a realistic recruitment target, and, therefore, one of the aims was to establish this. The proposed recruitment period was 6 months with a monthly target of 16 participants. However, recruitment across all sites was initially very poor. After adjusting the recruitment strategy (to a direct approach by face-to-face conversations at clinics or by mail-out of study packs), recruitment rates picked up significantly. However, this was at the ending point of the recruitment phase so an emergency TSC was convened and the study progress was discussed. The chairperson of the TSC supported the proposal to extend recruitment and add on a no-cost extension. This would be for a maximum of 6 months only. This was agreed with the funders but it also meant that anyone recruited after October 2017 would only be followed up for 6 months. At the end of (the extended) recruitment period, a total of 72 participants had been recruited and randomised into the study. At the closure of recruitment on 31 December 2017, a few CtoC forms were still received from interested patients. It could have been possible to reach the target with an extra 3 months of the study being open, and at the close of study there were more CtoCs forms received that we were unable to process.

The recruitment chart by month demonstrates an exponential increase in recruitment over time, as can been seen in Figure 4, and the trajectory suggests that it would have been possible to recruit to target. It is also worth noting that only two of the sites recruited to their own targets of 25 participants (LYPFT and C&IFT). The other two sites experienced problems in being able to recruit and support the study. We did add additional sites to compensate; by the time they opened to recruitment there were only 2–3 months left of the recruitment period. Future studies should ensure that there is sufficient capacity in each NHS site for the duration of the study and that there are no planned service transformations that will greatly affect engagement and recruitment.

Recruitment methods

A large proportion of people in the care of CMHTs were potentially eligible as a result of the broad eligibility criteria. A range of strategies were adopted to enable those people to learn more about the study and consider participation. These strategies included giving their case managers a study pack to pass on, handing out leaflets at clinics and service users groups, posting out the packs to participants’ homes and adding in a ‘callback’. All of the strategies that we adopted yielded CtoCs. Clearly the biggest challenge for the recruitment was in the initial marketing to both care co-ordinators and participants themselves. The RESPECT study is the first study on the topic of the sexual health of people with SMI in the UK (and Europe). It has already been established that this topic is one that is routinely avoided in mental health care4 and, knowing this, the study team engaged with each service area prior to recruitment by visiting team meetings, providing written information, as well as providing regular e-newsletters on the progress of the study. However, it became apparent that there were some significant issues in terms of clinical staff understanding of research in general and their role in the promotion of the study (including a lack of awareness of patients’ rights in the NHS constitution to be informed of studies that they may be eligible for). In addition, it seems that the topic itself created some anxiety on the part of the care co-ordinators. All people who received a recruitment pack were given a feedback questionnaire to complete whether or not they entered the study. We received 158 feedback questionnaires and 42% of those had declined to take part. The main reason for declining was ‘topic not relevant’. Only two responses related to being put off by the topic itself or the design of the study.

A future trial can use the learning from the RESPECT study to offer reassurance to both service users and mental health staff that this is an acceptable and feasible study, and does not lead to adverse effects. We should be clearer in the information leaflets and other marketing material regarding the nature of the intervention, as a significant number of people saw it as not relevant to them. The involvement of those PWLE will also be important in ensuring that staff understand the purpose of the study and support recruitment from their perspective. It will be important to harness the voices of the service user participants who overwhelmingly found the study to be comfortable, interesting, thought-provoking and novel.

Participant characteristics

One of the research aims was to see if people under the care of community mental health services could be recruited to and retained in a sexual health promotion study. Most of those identified were eligible and (of those who expressed an interest) agreed to take part in the study. The average age was 44.8 years (range 22–66.1 years). Many participants were not in a relationship, lived alone or with friends/family, and many were not sexually active within the 3-month windows of assessment at baseline, 3-month and 6-month follow-up points. Most of the participants identified as heterosexual; 15.2% identified as other sexualities (lesbian, gay bisexual, transsexual, pansexual). This is higher than estimated in the general population as the Natsal-358 reported 97.1% of a representative sample of adults in Britain identified as heterosexual. The sample was equally split between males and females, although 3% preferred not to state their gender. The quality of life of participants was measured as having a mean of 44 on the ReQoL, which indicates that we recruited a clinical population, as scores of > 50 are defined as falling into the range of general population scores. In terms of drug and alcohol use, on average this was scored as low risk across the cohort using the ASSIST. A future study should consider the fact that there is a large range of, and fluctuation in, sexual activity when determining sample size. However, in summary, as planned we were able to recruit people who were under the care of the community mental health services.

Participant safety

Over the whole study, no AEs related to the study were recorded. Robust processes were in place to monitor for SAEs and researchers prompted participants for any AEs at each data collection point. The researchers also checked with the CSOs at each site regarding the well-being of the participants prior to data collection points. The interventionists were also asked to inform the research team if they became aware of any potential AEs. One potential AE was reported, but following investigation at the NHS sites and review by the research team (and Independent Steering Group chairperson and DMEC chairperson) it was ruled that this was unrelated to participation in the study. There was only one other issue that was reported by a care co-ordinator, and that was that one participant had become ‘pre-occupied’ with sexual health concerns following the baseline data collection. The study researcher was only informed of this when the 3-month follow-up appointment was due and, after further enquiry with the case manager, it was discovered that the participant had not deteriorated to such an extent that they required an escalation of care, such as an inpatient admission. Therefore, it was agreed that, according to the risk protocol, no AE had occurred. However, in discussion with the participant, it was agreed not to collect follow-up data.

Retention

At the 3-month follow-up point, data were collected on 81.9% of the participants (n = 59), and for those who reached the 6-month follow-up (which was a subsample of 38 participants), 76.3% (n = 29) completed the interview.

The retention rates are acceptable and on a par with other health intervention studies with SMI populations conducted in the UK43 and with previous sexual health promotion studies conducted in the USA. 33

Completeness of the outcome measures

Overall, the participants found the data collection process to be acceptable. In the qualitative study, they did report that it was quite long, and feedback from the researchers also indicated that the length (approximately 1 hour 30 minutes) might be a bit too long for the baseline. There was some feedback that there was some repetition between the outcome measures, and that the case report form (CRF) could be streamlined to reduce the length and the repetition. The £10 shopping voucher that was given at each data collection point was helpful in encouraging attendance and was deemed ‘about right’ in terms of incentive. Recommendations for a future study included more clarity on the exact nature of the questions (one participant reported feeling a bit shocked that he was asked about sex with men, when he had already stated that he was heterosexual) and that it would be useful to schedule some breaks to be added into the data collection appointment (or over a couple of sessions). The researchers had been advised to offer breaks to participants and to be flexible regarding the data collection. If the CRF was reduced for a future study then this would hopefully resolve the issue of needing breaks. However, it is always good practice to make the data collection appointments as comfortable as possible, so the option for breaks will remain (as will support to read and answer the questionnaires).

The study was underpowered to detect statistically significant differences in outcomes between intervention and control at follow-up. There were some trends in favour of the intervention but these cannot be considered as robust with such small numbers. Only a fully powered study would be able to confirm effectiveness. These are summarised as:

• HIV-KQ knowledge – there was a trend towards a slight increase in knowledge score in the intervention arm compared with the control arm at 3 months.

• Use of sexual health services – the use of sexual health and family planning services was low in this population; the intervention group had a higher use of sexual health services at baseline. However, as the numbers are so small (in terms of use), no conclusions can be drawn regarding the intervention. However, this does indicate that some of the people we recruited did experience current sexual health needs.

• Quality of life – there were no discernible changes to ReQoL scores (a reliable change is defined as at least 10 points on average).

• Sexual risk behaviour – there was some reduction in reports of condomless sex at 3 months in the intervention arm, but not in the control arm. It is important to note that all participants were given condoms at baseline (as well as during the intervention) and yet the only reduction was seen in those who had accessed the intervention. Not all participants were sexually active during the period of the study; yet, of those who were, none reported increased condomless sex as a result of taking part, suggesting that participation does not encourage unsafe sex.

• Many of the participants described themselves as single and most were not having sex during the 3-month follow-up periods. However, among the people who were having sex, most of this was unprotected (condomless) at baseline. More women than men reported actively engaging in sex. There was a clear reduction in unprotected vaginal sex acts in the intervention group at 3 months and 6 months. This was a particularly obvious reduction for women. There were very few anal sex acts so it is difficult to comment on these data. There were no changes in unprotected oral sex but this is a relatively low-risk activity (compared with condomless anal and vaginal sex). 59

• Motivations to adopt safer sex – most of the participants did not perceive themselves at high risk for STIs based on previous behaviour or future behaviour. There was a slight shift in proportions reporting higher risk perceptions at 3 months.

• Condom self-efficacy – the mean score in the intervention arm was higher at 3 months than in the control arm.

• Behavioural intentions to adopt safer sex – there was an increase in scores at 3 months for the intervention arm, and the control arm scores were slightly lowered.

Specific lessons from the feasibility study

The learning from the RESPECT study provides unique insight into how a successful definitive trial should be conducted.

Trial implementation

Two of the original four sites experienced difficulties that affected the capacity to deliver on the targets for the study. In SPFT, delays to the start of the recruitment period affected the capacity to deliver the intervention and, therefore, recruitment was ceased at the point they could no longer provide the intervention. In SWYFT, the community mental health services in the designated locality of Barnsley underwent a complete service transformation. Had the study recruitment start date not been delayed, we could have continued to engage with the existing services up to the point of transformation. However, recruitment was greatly affected by this as team managers changed and also individual care co-ordinator’s caseloads changed so it was very difficult to undertake screening and recruitment during this period. We did engage other sites during the summer of 2017, but by the time they were open to recruitment there was only a few weeks of the recruiting period left. Future studies should factor in engaging with more sites than are actually required at the start of the study as ‘contingency sites’ that would be ready to open to recruitment should the need arise.

Some participants who took part in the qualitative study had not understood the process of randomisation, and this is not an uncommon phenomenon. 60 A future trial should attend to the explanation of the purpose of randomisation and build in a check of understanding to ensure that all participants understand why randomisation is used in intervention studies.

Delivery of intervention

It is not uncommon for intervention studies to experience logistical problems. The intervention is provided by the NHS and is an ‘excess treatment cost’ as opposed to a research cost. Although much work was undertaken to engage with the NHS sites regarding the provision of staff who would be able to deliver a trial intervention, the reality of providing that intervention from the clinical services at a time of increased demand is one of the main challenges of conducting intervention research in real-world settings. Owing to service demands and natural staff attrition, the interventionists are likely to change within the study period. However, the significant initial delays in recruitment added to the challenges as those originally identified had moved on by the time the first participants came through (in some cases several months after the first wave of intervention training had occurred).

In the RESPECT study, interventionist attrition was mostly resolved by training new people to deliver at each site but in the case of C&IFT, the loss of anyone to provide the intervention for some weeks meant that recruitment for some of the participants had to be stalled. A future study should aim to have a rolling programme of training for staff to be able to deliver the intervention throughout the study period to account for role changes, new jobs, maternity and other leave that naturally occurs in the workforce. This is especially pertinent as a definitive trial is likely to be open to recruitment for a longer period than the RESPECT study and is, therefore, at risk from interventionist attrition.

There were no significant issues reported from the interventionists regarding the logistics of arranging appointments, and the intervention sessions were conducted in a range of settings, such as private rooms at a local NHS site, or in the person’s own home.

Recruitment rates

No single method of recruitment seemed more effective than the others and so the recommendation would be to keep a range of strategies for recruitment in a subsequent study. In terms of feedback from participants, there were comments suggesting that having someone to talk through the study with was really valued and this could be the care co-ordinator or one of the researchers. It is also recommended that initial information and marketing is kept brief so a future study should consider a layered approach to information giving, using a brief easy-to-read leaflet first before receiving the full PIS. Recommendations for improving recruitment are as follows:

1. More intensive engagement with CMHTs – a future study should ensure that the research team is given adequate time to spend with the CMHT teams prior to the commencement of recruitment. In the qualitative studies, participants stated that they preferred to be provided with information from their case manager rather than receive a leaflet or mail-out. It is important that this feedback is communicated to the team in order to encourage them to mention the study face to face. In preparation for recruitment, it will be important that the concerns regarding the study topic are addressed in the information that is given out (for both the staff and the service users). From the qualitative study and the exit questionnaires there are many positive reasons for taking part and positive experiences of the study, which can be communicated in the next phase.

2. The length of data collection appointments – in the feedback questionnaires and anecdotally, some potential participants may have been deterred from taking part because of the burden of data collection. Although this did not seem to be a major issue for the actual participants (the information sheet clearly stated a completion time of up to 2 hours). After reviewing the data and the fact that participants found some aspects repetitive, it will be important to streamline the data that are collected and reduce the data collection appointment to a target of 1 hour. Despite the SERBAS being the ‘gold standard’ of sexual risk behaviour assessment, it is time-consuming and collects a large number of data, which, although really useful in terms of profiling risk behaviour, is limited by the burden of length of time to complete. It is recommended that a future study should simply focus on collecting data on the number of partners over the past 3 months, the total number of episodes of condomless anal, vaginal and oral sex (across all partners) and episodes of sex trading (condomless). Reducing the questions used from the SERBAS would significantly reduce the time of the interview.

3. Using the positive experience of the participants in future information and promotional materials – the overwhelming feedback of those who took part was that it was interesting, thought-provoking and something novel. They also felt comfortable with the data collection process and, for those who received it, with the intervention itself. Using this positive feedback may assist more potentially eligible people to take part and allay some concerns people might have.

Retention rates

Retention rates in the study were good and one of the things that may have helped this was the £10 voucher, but also the consistency of seeing the same researcher and at a location and time to suit the participant. We were able to offer appointments after working hours for some of the participants who worked or who had other daytime commitments.

Resource use and health-related quality of life

The economic analysis evaluated the feasibility of collecting data on resource use and health-related quality of life. Data were collected on intervention-related costs, self-reported health service visits/consultations and quality of life based on EQ-5D-5L. The intervention cost per patient was estimated to be £110.50 (range £65.70–146.00); in addition, a one-off cost of training the interventionists was estimated to be £475.20 per health professional trained. Questionnaire response rate, item completion rate and changes in resource use and quality of life over the trial follow-up period were also evaluated. Health service resource use data had a very high completion rate among respondents who continued the trial. The pharmacy visits question had the most missing values at baseline but the overall rate of missing items was very low. Visits to the GP and nurse were the most common types of resource use. It was noted that visits to A&E were low and unrelated to sexual health problems, and given their cost it may be useful to reconsider whether or not they should be included in a full trial. Regarding the EQ-5D-5L questionnaire, there was no missing data among respondents who stayed in the study. During the study follow-up, the intervention arm showed more improvement in quality of life than the control arm; however, given the sample size, no statistically significant conclusions can be drawn. Overall, the economic analysis suggested a high level of questionnaire completion rate and a low level of item missingness in participants who stayed in the study; moreover, we did not find any unreasonable or out-of-range responses.

The summary of recommendations for the design and implementation of a future trial is as follows:

• More in-depth engagement at sites to ensure that CMHT staff are fully conversant with the aims of the trial and reassured regarding risk and safety for participants.

• Reduction in the length of time required for data collection by streamlining the CRF.

• Recruitment period to be set to reflect the actual recruitment rates identified in this feasibility study.

• Engage more NHS sites and intervention staff at the start of the study and have contingencies in place to provide a critical mass of people at each site to deliver intervention.

Summary of implications for practice

Previous studies have suggested that sexual health is a topic that is often avoided in mental health. However, the findings from the RESPECT study do indicate that this topic is of interest to people with SMI and that, for some, it is a priority. Although the sample may not be representative of people with SMI (as participants self-selected to participate), the data indicate that some people have poor knowledge about sexual health risks, have low perceptions of risk and motivation to engage in safer sex, and, by self-report, are engaging in condomless vaginal sex. While acknowledging that this is not a representative sample, these findings do confirm the findings from studies undertaken in the USA and support the view that sexual health and relationships are important aspects of health for people with SMI (as for the general population). Around half of the sample did not report sex in the 3 months prior to data collection and they were asked to tick up to three reasons for this. The most common answers were ‘not having a partner’ followed by ‘not interested in sex’ and ‘psychiatric illness/medication-related problems’. It is possible that having a mental illness has an impact on people’s sex life by impeding their ability to find and maintain intimate relationships; even if they do find a relationship, illness and medication factors could affect their sexual desire and functioning. A study by McCann20 about relationships of people with psychosis suggests that sexual relationships are something that people aspire to have and that loneliness and isolation,61 as well as stigma17 around having a mental illness, could have an impact on people’s ability to form and maintain intimate partner relationships.

In the RESPECT study, all participants were given male condoms and sachets of water-based lubrication, as well as information about local sexual health services. These are relatively straightforward interventions, yet we know from surveys conducted in the UK that condoms are not routinely provided in mental health services. In addition, mental health staff appear to lack knowledge about local services. There is a need for mental health services to consider providing standard health promotion information to all service users.

Recommendations for further research

The RESPECT study was designed to assess the feasibility and acceptability of a sexual health intervention. A fully powered RCT would be required to establish effectiveness. There is a need for a further, more robust, examination of the factors that are associated with sexual risk behaviour for people with SMI and what factors mediate risk (e.g. hypersexuality). Meade and Sikkema6 reviewed the literature on the link between having a mental illness and sexual behaviour, and none of the studies had been conducted in the UK (mostly in the USA). One of the key concerns raised by the implementation of the study was resistance to the topic by mental health staff. Further research should examine how to enable staff to engage with service users regarding sexual issues in the context of routine care as well as for the support of future research. An area that was beyond the scope of this study was to examine the needs of sexual health and family planning practitioners in the delivery of sexual and reproductive health for people with SMI, and what the care pathways should be in order for people with SMI to effectively navigate them.