A cluster‐randomized controlled trial of a combination HIV risk reduction and economic empowerment intervention for women engaged in sex work in Uganda
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: 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.
DOI: 10.1002/jia2.70057
Language: English
Topic: Sex work and related issues
Subfield: Sociology and Political Science
Field: Social Sciences
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $2,600
Funders: Exact Sciences Corporation, World Health Organization, CHDI Foundation, Unilever, Genome Canada, Education Department of Hunan Province, Henan Normal University, Freiwillige Akademische Gesellschaft, Wellcome Trust, Ministerio de Ciencia, Innovación y Universidades, Chan Zuckerberg Initiative, Health~Holland, Georgia Clinical and Translational Science Alliance, Universidad Politécnica Salesiana del Ecuador, National Institute for Health and Care Research, British Heart Foundation, University of Bath, Deutsche Forschungsgemeinschaft, Agence Nationale de la Recherche, Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, National Natural Science Foundation of China, ZonMw, Chang Gung University, China Postdoctoral Science Foundation, Anhui Medical University, Erasmus Medisch Centrum, Fonds Wetenschappelijk Onderzoek, Ministry of Health, Labour and Welfare, Korea Health Industry Development Institute, National Research Foundation of Korea, China National Offshore Oil Corporation, Hjärt-Lungfonden, KU Leuven, Qatar University, Narodowe Centrum Nauki, Vetenskapsrådet, Universiteit Gent, Natural Science Foundation of Guangxi Province, Isfahan University of Technology, Centre National de la Recherche Scientifique, Natural Science Foundation of Henan Province, Ministerstvo Zemědělství, Univerzita Palackého v Olomouci, Addis Ababa University, Universität Leipzig, Health and Family Planning Commission of Gansu, Astma- och Allergiförbundet, Guizhou Medical University, Indian Institute of Technology Mandi, Bagui Scholars Program of Guangxi Zhuang Autonomous Region, Consejería de Conocimiento, Investigación y Universidad, Junta de Andalucía, Sorbonne Université, National Institutes of Health, Health Resources and Services Administration, Centro de Investigação em Materiais Cerâmicos e Compósitos, Merck Sharp and Dohme, Natural Sciences and Engineering Research Council of Canada, Research Trainees Coordinating Centre, Health Technology Assessment Programme, National Health and Medical Research Council, Japan Society for the Promotion of Science, Fundação para a Ciência e a Tecnologia, Natural Science Foundation of Anhui Province, National Key Research and Development Program of China, Fundamental Research Funds for the Central Universities, Basic and Applied Basic Research Foundation of Guangdong Province, National Institute of Mental Health, National Institute on Drug Abuse, National Institute of General Medical Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Institute of Health Services and Policy Research, Natural Science Foundation of Zhejiang Province, Songshan Lake Materials Laboratory, Cambridge BHF Centre of Research Excellence, Social Sciences and Humanities Research Council, National Taiwan University Hospital Hsin-Chu Branch
OpenAlex ID: W4416067557