A cluster-randomized controlled trial of a combination HIV risk reduction and economic empowerment intervention for women engaged in sex work in Uganda.

INTRODUCTION: Women engaged in sex work (WESW) in Uganda face a high risk of HIV and other sexually transmitted infections (STIs), driven by the intersection of gender inequality, poverty and structural barriers. This paper reports on the Kyaterekera Project, a cluster-randomized controlled trial (c-RCT) testing the efficacy of a combined HIV risk reduction (HIVRR) and economic empowerment intervention to reduce biologically confirmed STIs and HIV risk behaviours. METHODS: The study recruited 542 WESW from 19 HIV hotspots across four districts in Uganda between June 2019 and March 2020. Participants were randomized into three groups: (1) HIVRR intervention alone; (2) HIVRR combined with financial literacy training and an unconditional matched savings account; or (3) HIVRR combined with financial literacy training and an unconditional matched savings account and vocational training. Although initially implemented as a three-arm c-RCT, the COVID-19 lockdown prevented the implementation of the vocational training component. Therefore, the two treatment groups were combined, and the trial was re-approved as a two-arm c-RCT. Biological assessments were conducted at baseline, 18 and 24 months. Behavioural assessments were conducted at baseline, 6, 12, 18 and 24 months from April 2019 to December 2023. Primary outcomes included incident HIV acquisitions (seroconversions among baseline HIV-negative participants), point prevalence of STIs at each visit, and the number/proportion of unprotected sexual acts with paying and regular partners. This study utilized community-based participatory research methods, engaging a community advisory board to ensure the study's alignment with local needs. RESULTS: Across follow-up, condomless sex with paying partners decreased and income shifted towards non-sex work in both arms; no between-group differences were detected. Eighteen incident HIV acquisitions occurred (14 by 18 months; 4 additional by 24 months) with no between-group differences. STI prevalence was lower at 18 months compared to baseline, but not sustained at 24 months. CONCLUSIONS: In an environment of high baseline HIV prevalence, substantial pre-exposure prophylaxis uptake and COVID-19 disruptions, the added financial literacy/savings components did not yield measurable incremental benefits over HIVRR alone. Integrating an unconditional matched-savings model within an HIVRR platform was feasible. CLINICAL TRIAL NUMBER: NCT03583541.