Effect of HIV Self-Testing on PrEP Adherence Among Gender-Diverse Sex Workers in Uganda: A Randomized Trial

Andrew Mujugira, Agnes Nakyanzi, Maria S Nabaggala, Timothy R Muwonge, Timothy Ssebuliba, Monica Bagaya, Olivia Nampewo, Oliver Sapiri, Kikulwe R Nyanzi, Felix Bambia, Rogers Nsubuga, David M Serwadda, Norma C Ware, Jared M Baeten, Jessica E Haberer, Andrew Mujugira, Agnes Nakyanzi, Maria S Nabaggala, Timothy R Muwonge, Timothy Ssebuliba, Monica Bagaya, Olivia Nampewo, Oliver Sapiri, Kikulwe R Nyanzi, Felix Bambia, Rogers Nsubuga, David M Serwadda, Norma C Ware, Jared M Baeten, Jessica E Haberer

Abstract

Background: HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP) are complementary tools that could empower sex workers to control their HIV protection, but few studies have jointly evaluated PrEP and HIVST in any setting.

Methods: The Empower Study was an open-label randomized trial in Uganda. Sex workers were offered F/tenofovir disoproxil fumarate and randomized 1:1 to monthly HIVST and quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing alone (standard of care) and followed up for 12 months. PrEP adherence was measured using electronic adherence monitoring and tenofovir diphosphate (TFV-DP) levels in dried blood spots. Adherence outcomes and sexual behaviors were compared by arm using generalized estimating equation models.

Results: We enrolled 110 sex workers: 84 cisgender women, 14 transgender women, 10 men who have sex with men, and 2 transgender men. The median age was 23 years. The 12-month retention was 75%. Nearly all (99.4%) used ≥1 HIVST kit. The proportion with TFV-DP levels ≥700 fmol/punch in the HIVST and standard of care arms at the 3-, 6-, 9-, and 12-month visits was 2.4%, 2.3%, 0%, and 0% and 7.9%, 0%, 0%, and 0%, respectively, with no differences by randomization arm (P > 0.2). Self-reported condomless sex acts with paying partners was similar by arm [adjusted incidence rate ratio 0.70; 95% confidence interval (CI): 0.42 to 1.17; P = 0.18]. One seroconversion occurred (HIV incidence, 0.9/100 person-years); TFV-DP was not detected at any visit.

Conclusions: A gender-diverse sample of sex workers in Uganda used HIVST but not daily oral PrEP for HIV protection. Alternate approaches to promote PrEP use, including long-acting formulations, should be considered in this population.

Trial registration: ClinicalTrials.gov NCT04328025.

Conflict of interest statement

A.M. received donated FTC/TDF from Gilead Sciences for this investigator-sponsored study and served as an advisor for ViiV Healthcare. J.M.B. served as an advisor for Gilead Sciences, Janssen, and Merck. J.E.H. is a consultant for Merck. The remaining authors have no conflicts of interest to disclose.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

FIGURE 1.
FIGURE 1.
Trial profile.
FIGURE 2.
FIGURE 2.
PrEP adherence by EAM and TFV-DP levels in DBS.
FIGURE 3.
FIGURE 3.
Correlation of PrEP adherence by electronic adherence monitoring and TFV-DP levels in DBS.

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Source: PubMed

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