Title: MoreRESPECT: A Randomised controlled trial of a sexual health promotion intervention for people with severe mental illness delivered in community mental health settings
Funder: Department of Health and Social Care

Abstract: This study focuses on people with severe mental illness (SMI) which includes bipolar affective disorder, psychosis and other long-term mental health problems that severely impact on daily activities. People with SMI also have problems with their physical health such as heart, breathing problems, diabetes, and cancers; however, less attention has been paid to sexual health. Like everyone else, positive sexual relationships are important for people with SMI but this is rarely discussed in routine mental health care. Therefore, they can be unaware of important information such as where to get sexual health advice, how to reduce risk of sexually transmitted infections; contraceptive choices, and finding relationships that are mutually respectful not violent or abusive. We are a team of researchers, doctors, nurses, and people with mental health lived experience who got funding from the National Institute for Health Research (NIHR) to carry out a previous smaller study called the RESPECT study. In that study, we worked with people with lived experience and those who work in sexual health to develop a 3 session support package that helped people with SMI to think about their own sexual health and provided useful information about how to improve their sexual health. We then evaluated the support package in a feasibility study (which is done to check whether people with SMI would want to join the study (recruitment) and stay in the study (retention). Our lived experience researchers interviewed participants over the phone and found that participants reported that the study felt safe, comfortable, convenient and useful. We were able recruit enough people, and able to keep people in the study until the end (retention), and there was good attendance at the support package sessions. There were no issues of people becoming distressed or more unwell because of taking part in the study. _x000D_ The MoreRESPECT study builds on our earlier study, and asks whether the support package will improve sexual health outcomes for people with SMI compared with those who don’t receive it. We will recruit 400 people with SMI (which should be enough numbers to be sure about our results) from community mental health teams from NHS mental health services across England and Scotland over 24 months. Information (data) will be collected about their sexual health, and they will be randomly allocated either to usual care or to receive usual care plus the support package. Random allocation (a bit like tossing a coin heads or tails) means an equal chance to receive the support package intervention or not. A local mental health worker (such as a peer worker, support worker, nurse etc) who received training from the MoreRESPECT team will then deliver the support package group for 3 x one-hour sessions to those allocated to it. Information will be collected at 3,6,9 and 12 months after recruitment. Those who were allocated to the support package will be compared with those who were not, to see if the support package improves sexual health across a range of things such as increasing safer sexual practices (e.g.using condoms), increase access to sexual health services, and motivation to adopt safer sexual practices. We will also do interviews with a small group of participants to find out how they found the study, and whether it worked better for some than others and in what circumstances. This will help make decisions about the best ways for this to be included in routine care if it is shown to be successful. We will work with NHS care providers, commissioners of healthcare, and people with lived experience of SMI to ensure that sexual health becomes part of routine care in mental health services.

Lay abstract: RESEARCH QUESTION: Is an intervention designed to promote sexual health for people with severe mental illness clinically and cost-effective?_x000D_ BACKGROUND: People with severe mental illness aspire to have positive sexual relationships, yet often have unmet sexual health needs including STI infections, domestic violence and unintended pregnancy. Sexual health is not addressed as part of the physical health agenda in mental healthcare. _x000D_ OBJECTIVES:_x000D_ 1) Undertake an eight-month internal pilot phase to confirm feasibility of the trial in terms of recruitment rate, retention rate, data completeness and intervention uptake. _x000D_ 2) Undertake a randomised controlled trial to determine whether a bespoke sexual health intervention reduces unprotected sexual acts. _x000D_ 3) Undertake an analysis of secondary outcomes including knowledge about sexually transmitted diseases, motivation to engage in safer sex, and condom use. _x000D_ 4) Assess the cost-effectiveness of the intervention compared to usual care and describe the implications for NHS resource management _x000D_ 5) Undertake a process evaluation to identify what worked (and what didn’t work), for whom, why, how and in what circumstances. _x000D_ METHODS: A multi-centre, pragmatic, two-arm, individually randomised controlled trial of the intervention versus usual care in patients with severe mental illness including an internal pilot, process evaluation, and cost-effectiveness analysis. _x000D_ SETTING: NHS community mental health services in England and Scotland_x000D_ SAMPLE: N=400 people with severe mental illness under the care of community mental health services_x000D_ OUTCOME MEASURES: Measures of unprotected sex acts over 12 months; Knowledge about HIV; Condom Attitudes; behavioural Intention to adopt safer sex; Quality of Life Measures EQ-5D and REQOL); health service use questionnaire_x000D_ INTERVENTION: a 3x 1hour manualised talking intervention that addresses knowledge, motivation and behavioural skills to promote sexual health including safer sex, contraceptive choices and promoting respectful and positive intimate relationships. Delivered via remote methods or face to face. _x000D_ COMPARATOR: Usual care (there is currently no specific sexual health promotion service for SMI in mental health; we would not prevent participants from accessing sexual health and other relevant services)_x000D_ All participants will be checked for eligibility and informed consent will be obtained. Baseline data will be collected and then they will be independently randomly allocated to intervention or usual care. Data will be collected at 3, 6, 9, and 12 months post-baseline._x000D_ ANALYSIS: The number of unprotected sex acts will be compared between groups using zero-rated Poisson regression model controlling for covariates. _x000D_ PROCESS EVALUATION: A nested Realist process evaluation will be undertaken with a sub sample participants (n-40)_x000D_ TIMELINES: The study will run for 49 months including a 6 month set-up, a 24 month recruitment window (first 8 months is pilot). Follow-up will be 12months leaving 7 months for analysis and report, ending month 49. _x000D_ ANTICIPATED IMPACT AND DISSEMINATION: As this is a neglected area of mental health, the impact of demonstrating the effectiveness of the intervention in promoting sexual health will be significant. The manual and all other outputs and resources will be free to download from the study website, and promoted in national clinical and academic networks. We will produce academic papers, lay summaries and blogs.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH