MoreRESPECT: A Randomised controlled trial of a sexual health promotion intervention for people with severe mental illness delivered in community mental health settings

RESEARCH QUESTION: Is an intervention designed to promote sexual health for people with severe mental illness clinically and cost-effective? 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. OBJECTIVES: 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. 2) Undertake a randomised controlled trial to determine whether a bespoke sexual health intervention reduces unprotected sexual acts. 3) Undertake an analysis of secondary outcomes including knowledge about sexually transmitted diseases, motivation to engage in safer sex, and condom use. 4) Assess the cost-effectiveness of the intervention compared to usual care and describe the implications for NHS resource management 5) Undertake a process evaluation to identify what worked (and what didn’t work), for whom, why, how and in what circumstances. 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. SETTING: NHS community mental health services in England and Scotland SAMPLE: N=400 people with severe mental illness under the care of community mental health services 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 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. 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) 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. ANALYSIS: The number of unprotected sex acts will be compared between groups using zero-rated Poisson regression model controlling for covariates. PROCESS EVALUATION: A nested Realist process evaluation will be undertaken with a sub sample participants (n-40) 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. 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.