Background/Setting: Randomized controlled trials (RCTs) of HIV biomedical prevention interventions often enroll participants with varying levels of HIV exposure, including people never exposed to HIV. We assessed whether enrolling larger proportion of participants with consistently high exposure to HIV, such as female sex workers (FSW), might reduce trial duration and improve the accuracy of product efficacy estimates in future HIV prevention trials.
Methods: We used an individual-based stochastic model to simulate event-driven RCTs of an HIV prevention intervention providing 80% reduction in susceptibility per act under different proportions of FSW enrolled. A 5% annual drop-out rate was assumed for both FSW and non-FSW in our main scenario, but rates of up to 50% for FSW were also explored.
Results: Enrolling 20% and 50% FSW reduced the median simulated trial duration from 30 months with 0% FSW enrolled to 22 months and 17 months, respectively. Estimated efficacy increased from 71% for RCTs without FSW to 74% and 76% for RCTs with 20% and 50% FSW enrolled, respectively. Increasing the FSW drop-out rate to 50% increased the duration of RCTs by 1-2 months on average and preserved the gain in estimated efficacy.
Conclusion: Despite the potential logistical challenges of recruiting and retaining FSW, trialists should revisit the idea of enrolling FSW in settings where HIV incidence among FSW is higher than among non-FSW. Our analysis suggests that enrolling FSW would increase HIV incidence, reduce trial duration and improve efficacy estimates, even if the annual drop-out rate among FSW participants is high.