TY - JOUR T1 - Comparison of community-led distribution of HIV self-tests kits with distribution by paid distributors: a cluster randomised trial in rural Zimbabwean communities JF - BMJ Global Health JO - BMJ Global Health DO - 10.1136/bmjgh-2021-005000 VL - 6 IS - Suppl 4 SP - e005000 AU - Euphemia Lindelwe Sibanda AU - Collin Mangenah AU - Melissa Neuman AU - Mary Tumushime AU - Constancia Watadzaushe AU - Miriam N Mutseta AU - Galven Maringwa AU - Jeffrey Dirawo AU - Katherine L Fielding AU - Cheryl Johnson AU - Getrude Ncube AU - Miriam Taegtmeyer AU - Karin Hatzold AU - Elizabeth Lucy Corbett AU - Fern Terris-Prestholt AU - Frances M Cowan Y1 - 2021/07/01 UR - http://gh.bmj.com/content/6/Suppl_4/e005000.abstract N2 - Background We compared community-led versus an established community-based HIV self-testing (HIVST) model in rural Zimbabwe using a cluster-randomised trial.Methods Forty village groups were randomised 1:1 using restricted randomisation to community-led HIVST, where communities planned and implemented HIVST distribution for 4 weeks, or paid distribution (PD), where distributors were paid US$50 to distribute kits door-to-door over 4 weeks. Individual level primary outcomes compared household survey responses by arm 4 months post-intervention for: (1) newly diagnosed HIV during/within 4 months following HIVST distribution, (2) linkage to confirmatory testing, pre-exposure prophylaxis or voluntary medical male circumcision during/within 4 months following HIVST distribution. Participants were not masked to allocation; analysis used masked data. Trial analysis used random-effects logistic regression.Distribution costs compared: (1) community-led HIVST, (2) PD HIVST and (3) PD costs when first implemented in 2016/2017.Results From October 2018 to August 2019, 27 812 and 36 699 HIVST kits were distributed in community-led and PD communities, respectively. We surveyed 11 150 participants and 5683 were in community-led arm. New HIV diagnosis was reported by 211 (3.7%) community-led versus 197 (3.6%) PD arm participants, adjusted OR (aOR) 1.1 (95% CI 0.72 to 1.56); 318 (25.9%) community-led arm participants linked to post-test services versus 361 (23.9%) in PD arm, aOR 1.1 (95% CI 0.75 to 1.49.Cost per HIVST kit distributed was US$6.29 and US$10.25 for PD and community-led HIVST, both lower than 2016/2017 costs for newly implemented PD (US$14.52). No social harms were reported.Conclusions Community-led HIVST can perform as well as paid distribution, with lower costs in the first year. These costs may reduce with programme maturity/learning.Trial registration number PACTR201811849455568.Data are available upon request. De-identified data are available. For access please contact the principal investigator, euphemia@ceshhar.co.zw. Protocol and statistical analysis plan are available. ER -