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The RESPECT study: a feasibility randomised controlled trial of a sexual health promotion intervention for people with serious mental illness in community mental health services in the UK

journal contribution
posted on 18.01.2021, 03:16 by Elizabeth HughesElizabeth Hughes, N Mitchell, S Gascoyne, T Moe-Byrne, A Edmondson, E Coleman, L Millett, S Ali, F Cournos, C Dare, C Hewitt, S Johnson, HD Kaur, K McKinnon, C Mercer, F Nolan, C Walker, M Wainberg, J Watson
© 2020, The Author(s). Background: People with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK. Method: The RESPECT study was a two-armed randomised controlled, open feasibility trial (RCT) comparing Sexual health promotion intervention (3 individual sessions of 1 h) (I) or treatment as usual (TAU) for adults aged 18 or over, with SMI, within community mental health services in four UK cities. The main outcome of interest was the percentage who consented to participate, and retained in each arm of the trial, retention for the intervention, and completeness of data collection. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers. Results: Of a target sample of 100, a total of 72 people were enrolled in the trial over 12 months. Recruitment in the initial months was low and so an extension was granted. However this extension meant that the later recruited participants would only be followed up to the 3 month point. There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it. At three months, 81.9% (30 I; 29 TAU) and at 6 months, 76.3% (13 I and 16 TAU) completed the follow-up data collection. No adverse events were reported. There was good completeness of the data. The sexual health outcomes for the intervention group changed in favour of the intervention. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n = 22). Conclusions: The target of 100 participants was not achieved within the study’s timescale. However, effective strategies were identified that improved recruitment in the final few months. Retention rates and completeness of data in both groups indicate that it is acceptable and feasible to undertake a study promoting sexual health for people with SMI. A fully powered RCT is required to establish effectiveness of the intervention in adoption of safer sex. Study registration: ISRCTN RegistryISRCTN15747739 prospectively registered 5th July 2016.

Funding

Funding was provided by the Health Technology Assessment Programme of the National Institute for Health Research. The funders had no involvement in the study, analysis and writing for publication. This study/project is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (14/172/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

History

Publication Date

17/11/2020

Journal

BMC Public Health

Volume

20

Issue

1

Article Number

1736

Pagination

13p. (p. 1-13)

Publisher

Springer Nature

ISSN

1471-2458

Rights Statement

The Author reserves all moral rights over the deposited text and must be credited if any re-use occurs. Documents deposited in OPAL are the Open Access versions of outputs published elsewhere. Changes resulting from the publishing process may therefore not be reflected in this document. The final published version may be obtained via the publisher’s DOI. Please note that additional copyright and access restrictions may apply to the published version.