Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial.

Journal: Journal of acquired immune deficiency syndromes (1999)

Volume: 97

Issue: 2

Year of Publication: 2024

Affiliated Institutions:  Research Department, The Infectious Diseases Institute Limited, Makerere University, Kampala, Uganda. Transgender Equality Uganda, Kampala, Uganda. Department of Medicine, University of California San Francisco, San Francisco, CA. Harvard Medical School, Boston, MA; and.

Abstract summary 

Peer-delivered HIV self-testing (HIVST) and sexually transmitted infection self-sampling (STISS) may promote adherence to oral pre-exposure prophylaxis (PrEP), but no studies have analyzed this approach among transgender women (TGW) in sub-Saharan Africa.The Peer study was a cluster randomized trial in Uganda (October 2020-July 2022; NCT04328025).Ten TGW peer groups, each with 1 TGW peer and 8 TGW, were randomized 1:1 to receive quarterly in-clinic HIV testing with PrEP refills as standard-of-care (SOC) or SOC plus monthly peer delivery of oral-fluid HIVST, STISS, and PrEP refills (intervention). Participants were followed for 12 months. The primary outcome was PrEP adherence.We screened 85 TGW and enrolled 82 (41 per arm). The median age was 22 years (interquartile range [IQR] 20-24). Twelve-month retention was 88% (72/82). At the 3, 6, 9, and 12-month clinic visits, 10%, 5%, 5%, and 0% of TGW in the intervention arm had TFV-DP levels ≥700 fmol/punch, versus 7%, 15%, 7%, and 2% in the SOC arm, respectively (P = 0.18). At all visits, any detectable TFV-DP levels were significantly higher in SOC than the peer delivery group (P < 0.04). PrEP adherence was associated with sex work (incidence rate ratio 6.93; 95% CI: 2.33 to 20.60) and >10 years of schooling (incidence rate ratio 2.35; 95% CI: 1.14 to 4.84). There was a strong correlation between tenofovir detection in dried blood spots and urine (P < 0.001). No HIV seroconversions occurred.Peer-delivered HIVST and STISS did not increase low levels of oral PrEP adherence among TGW in Uganda. Long-acting PrEP formulations should be considered for this population.

Authors & Co-authors:  Mujugira Andrew A Karungi Beyonce B Nakyanzi Agnes A Bagaya Monica M Nsubuga Rogers R Sebuliba Timothy T Nampewo Olivia O Naddunga Faith F Birungi Juliet E JE Sapiri Oliver O Nyanzi Kikulwe R KR Bambia Felix F Muwonge Timothy T Gandhi Monica M Haberer Jessica E JE

Study Outcome 

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Statistics
Citations :  UNAIDS. AIDS TARGETS. Prevailing against pandemics by putting people at the centre. UNAIDS; 2022; 2025. https://aidstargets2025.unaids.org/assets/images/prevailing-against-pandemics_en.pdf. Accessed March 6, 2023.
Authors :  15
Identifiers
Doi : 10.1097/QAI.0000000000003471
SSN : 1944-7884
Study Population
Women
Mesh Terms
Humans
Other Terms
Study Design
Randomized Control Trial
Study Approach
Country of Study
Uganda
Publication Country
United States