Oral pre-exposure prophylaxis uptake, adherence, and adverse events among South African men who have sex with men and transgender women

Abstract

Background: HIV prevention programmes that include pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) and transgender women (TGW) in South Africa have not been widely implemented.

Objectives: The authors examined oral PrEP uptake, adherence, and adverse events among HIV-uninfected MSM and TGW to inform intervention acceptability and feasibility.

Method: In 2015, MSM and TGW in two South African cities were offered a comprehensive package of HIV prevention services, including daily oral PrEP, and were followed for one year. Different models of PrEP delivery were used at each site. Adherence was measured using self-report and pill-count data and tenofovir-diphosphate (TFV-DP) concentrations.

Results: Among 135 participants who were eligible for PrEP, 82 (61%) initiated PrEP, of whom 67 (82%) were on PrEP at study end. Participants were on PrEP for a median of 294 out of 314.5 possible days (93% protected days). The median time from PrEP initiation to discontinuation or study end was 305 days (interquartile range: 232-325 days). Across the follow-up time points, 57% - 72% of participants self-reported taking protective levels of PrEP and 59% - 74% were adherent to PrEP as indicated by pill counts. Fewer (≤ 18%) achieved protective TFV-DP concentrations of ≥ 700 fmol/punch in dried blood spots. Side effects, while typically mild, were the most commonly cited reason by participants for early PrEP discontinuation.

Conclusion: Many MSM and TGW initiated and maintained PrEP, demonstrating that PrEP can be successfully delivered to South African MSM and TGW in diverse programmatic contexts. Biologic adherence measures suggest MSM and TGW may experience challenges taking PrEP regularly. Counselling for coping with side effects and motivating daily pill taking is recommended to support South African MSM and TGW in achieving protection with PrEP.

Keywords: HIV; HIV prevention; South Africa; men who have sex with men; pre-exposure prophylaxis; sexually transmitted infections; transgender women.

FIGURE 1

Pre-exposure prophylaxis continuum among South African men who have sex with men and transgender women in a combination HIV prevention trial, 2015.

FIGURE 2

Proportion of available days on and off pre-exposure prophylaxis by study site among South African men who have sex with men and transgender women in a combination HIV prevention trial, 2015.

FIGURE 3

(a, b) Kaplan-Meier survival analysis for time to first pre-exposure prophylaxis stop or study end (for those who did not stop pre-exposure prophylaxis), overall and by site among South African men who have sex with men and transgender women in a combination HIV prevention trial, 2015. (c, d) Kaplan-Meier survival analysis for time to last pre-exposure prophylaxis stop or study end (for those who did not stop pre-exposure prophylaxis), overall and by site among South African men who have sex with men and transgender women in a combination HIV prevention trial, 2015.

FIGURE 4

Patterns of pre-exposure prophylaxis stops and restarts for all pre-exposure prophylaxis initiators among South African men who have sex with men and transgender women in a combination HIV prevention trial, 2015. Each stop represents ≥ 14-days off pre-exposure prophylaxis. Time in days is median time from pre-exposure prophylaxis stop to restart and interquartile range.

FIGURE 5

Oral HIV pre-exposure prophylaxis adherence measures among 45 men who have sex with men and transgender women from Cape Town, South Africa in a combination HIV prevention trial, 2015.