Conducting a randomised controlled trial of a sexual health intervention during the COVID-19 pandemic: lessons learned

Abstract

Sexually transmitted infections (STIs) pose a significant public health challenge and correct and consistent condom use is the most effective means of reducing STI transmission. We adapted the Kinsey Institute Home-Based Intervention Strategy (Kl-HIS)1 to promote condom use among young men aged 16-25 years in England. We developed and feasibility tested two intervention delivery models: face-to-face (ProHIS2) and digital-only (eHIS3). Funded by the Public Health Research Programme of the National Institute for Health and Care Research (NIHR), we conducted a randomised controlled trial (RCT) to test whether the intervention, delivered by either ProHIS or eHIS, would be effective compared to usual condom information and distribution care offered by the National Health Service (NHS).4 The trial was a three-arm parallel-group RCT (1:1:1 allocation, two intervention arms vs. usual care) with baseline measurement, monthly follow-up questionnaires, and up to three STI screening points (baseline, 6 months, and 12 months). Participants had to be aged between 16–25 years, have a penis, be a UK resident, and be at self-identified risk of STIs (e.g. reported condom use errors or condomless sex (anal/vaginal) with a casual or new sexual partner in the past 3 months). The primary outcome was Chlamydia trachomatis test (CT) positivity; secondary outcomes were frequency of condomless sex, reported condom use errors and problems, and condom use attitudes and behaviours. The trial was powered at 90% to detect a reduction in positivity rates from 11% (observed among men aged 15–24 years in U.K. national screening4 to 6% at 6 months post-randomisation. For details of the intervention, see Stone et al.3,5
The trial required recruitment of individuals from NHS sexual health clinics4; our original target sample was 2231. Healthcare staff were trained to identify and enrol participants, deliver the intervention/usual care arms, and collect and process samples (urine and swabs) for on-site CT screening. The recruitment strategy and eligibility criteria were carefully tailored to target individuals at the highest risk of CT.1 Eight recruitment sites were established with the assistance of a Clinical Research Network (CRN): sexual health services in seven NHS trusts and one university health centre.
The HIS-UK trial opened to recruitment in one site on March 13, 2020. The first UK lockdown began on March 23, 2020 (see timeline-lockdown-social (instituteforgovernment.org.uk). On March 30, in line with NIHR guidance, recruitment was halted. Most sexual health clinics changed their working patterns; some staff were considered to be at high risk of contracting COVID and required to work from home, others were redeployed to other clinical areas. A UK outbreak of Mpox in May 20226 further took up clinic staff time, particularly in London. Open clinics operated with a smaller number of staff. Clinics changed to telephone triaging all patients, offering telemedicine consultations, only seeing patients face-to-face if essential, and advising patients with no symptoms to order self-sampling STI kits via web-based services.
In June 2021, recruitment for our trial resumed with a revised protocol reflecting post-COVID NHS working directives, specifically a reduction in direct clinical contact time with trial participants, and increased provision of remote research participation and care delivery. NHS Trusts prioritized studies on COVID and Mpox. Later in 2021, restarting other research was dependent on local situations and capacity.

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Identifiers

ORCID for Cynthia Graham: orcid.org/0000-0002-7884-599X

ORCID for Nicole Stone: orcid.org/0000-0003-0995-8699

ORCID for Nuala Mcgrath: orcid.org/0000-0002-1039-0159

ORCID for Leanne Morrison: orcid.org/0000-0002-9961-551X

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