JMIR Publications

ABSTRACT

Background:

Pre-exposure prophylaxis (PrEP) is highly effective in the prevention of HIV acquisition, particularly for men who have sex with men (MSM). Questions remain on the benefits of PrEP and implementation strategies for those at occupational risk of HIV acquisition in sex work, as well as on methods to support adherence among young people who initiate PrEP.

Objective:

The Combination Prevention Effectiveness (COPE) study for young MSM and transgender women (TGW) aims to assess the effectiveness and cost-effectiveness of a combination intervention among HIV-uninfected young MSM and TGW engaged in sex work in Thailand.

Methods:

This open-label, non-randomized assessment compares the relative effectiveness of a combination prevention intervention with and without daily oral tenofovir/emtricitabine (Truvada) PrEP with technology-based adherence support via short message service (SMS) reminders. HIV-uninfected young MSM and TGW aged 18-26 in Bangkok and Pattaya who self-report selling/exchanging sex at least once in the previous 12 months are recruited by convenience sampling and peer referral and are eligible regardless of their intent to initiate PrEP. At baseline, participants complete a standard assessment for PrEP eligibility, and may initiate PrEP then or at any time during the course of study participation. All participants complete a survey and HIV testing at baseline and every 3 months. Participants who initiate PrEP complete monthly pill pickups and may opt-in to SMS reminders. All participants are sent brief weekly SMS surveys to assess behavior with additional adherence questions for those who initiated PrEP. Adherence is defined as use of four or more pills within the last 7 days. The analytic plan uses a person-time approach to assess HIV incidence, comparing participant time on oral PrEP to participant time off oral PrEP for 12-24 months of follow-up, using a propensity score to control for confounders. Enrollment is based on the goal of observing 620 person-years (PY) on PrEP and 620 PY off PrEP.

Results:

As of February 2019, 445 participants (417 MSM, 28 TGW) have contributed approximately 168 PY with 94.8% (73/77) retention at 12 months. A total of 330 participants (74%) initiated PrEP at baseline, contributing to 134 PY of PrEP adherence, 1 PY non-adherence, and 33 PY PrEP non-use/non-initiation. Some social harms, predominantly related to unintentional participant disclosure of PrEP use and peer stigmatization of PrEP and HIV, have been identified.

Conclusions:

The majority of MSM and TGW who exchange sex and participate in this study are interested in PrEP, report taking sufficient PrEP, and stay on PrEP, though additional efforts are needed to address community misinformation and stigma. This novel multi-level, open-label study design and person-time approach will allow evaluation of the effectiveness and cost-effectiveness of combination prevention intervention in the contexts of both organized sex work and exchanged sex.