Stone, Nicole, Graham, Cynthia, Bremner, Stephen, McGrath, Nuala, Bedford, Rowena, Brown, Katherine E., Newby, Katie, Clarke, Amanda, Jackson, Louise, Morrison, Leanne, Nadarzynski, Tom and To, Ye (2024) Evaluating the home-based intervention strategy (HIS-UK) to reduce new chlamydia infection among young men aged 16-25 years by promoting correct and consistent condom use: findings from a randomised controlled trial. BMC Health Services Research, 24, [1607]. (doi:10.1186/s12913-024-11911-2).
Abstract
Background: correct and consistent condom use is the most effective method to reduce transmission of sexually transmitted infections (STIs).
Objective: to compare the HIS-UK intervention to usual condom information and distribution care for effect on chlamydia test positivity.
Methods: trial design A 3-parallel arm randomised controlled trial (1:1:1 allocation, two intervention arms vs. control). Randomisation using permuted blocks of varying lengths, with stratification by site, ethnicity and sexual-partnering risk. Repeated measures design with monthly follow-up to six months post-randomisation.
Setting: sexual health services in seven NHS Trusts and one university medical centre. Telephone and video consultations, online and in participants’ homes in England, UK.
Participants: target sample of 2231 men and people with penises, aged 16-25, at risk of STIs.
Intervention: HIS-UK delivered (1) face-to-face by health professionals (proHIS) or (2) digitally (eHIS). Two-weeks self-practice and experimentation using the HIS-UK condom kit.
Primary health outcome: chlamydia test positivity by six-months.
Secondary outcomes: frequency of unprotected sexual intercourse, reported condom use errors and problems, attitudes and use experience.
Analyses: chlamydia test positivity by six months analysed by logistic regression. Secondary outcomes analysed using linear mixed effects models with fixed effects and a random effect for the repeated measures, and generalised estimating equations with a logit link, adjusting for fixed effects and specifying an autoregressive-1 correlation structure.
Results: seven hundred twenty-five participants (proHIS:241, eHIS:243, control:241) randomised. 575 participants completed all baseline activities, 189 (32.9%) reached six-months post-randomisation. The absolute difference in chlamydia test positivity between arms was -4.9 percentage points at six months (7.9% HIS-UK, 12.8% control). The odds of chlamydia test positivity during follow-up were 55% lower for HIS-UK participants (p=.261).
HIS-UK showed a positive impact on recent condom use over time (p<.001). Significant reductions in condom errors and problems among HIS-UK participants were observed (p=.035). Lubricant use increased among HIS-UK participants, with evidence of an intervention-by-time interaction (p=.051), and a decline in poor condom fit and feel reports, but without intervention effect.
Conclusions: this study provides valuable insights into the potential of HIS-UK to enhance sexual health practices among at-risk populations at-risk of STI transmission.
Trial registration: ISRCTN registration: 11400820 (23/10/2019).
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