Testing the effectiveness and cost-effectiveness of a combination HIV prevention intervention among young cisgender men who have sex with men and transgender women who sell or exchange sex in Thailand: Protocol for the combination prevention effectiveness study

• Type of Material: Article
• Authors: Andrea L. Wirtz, Johns Hopkins Bloomberg School of Public Health; Brian Wilson Weir, Johns Hopkins Bloomberg School of Public Health; Sandra Hsu Hnin Mon, Johns Hopkins Bloomberg School of Public Health; Pachara Sirivongrangson, Thailand Ministry of Public Health; Tareerat Chemnasiri, Thailand Ministry of Public Health; Eileen F. Dunne, Thailand Ministry of Public Health; Anchalee Varangrat, Thailand Ministry of Public Health; Andrew C. Hickey, Thailand Ministry of Public Health; Michele R. Decker, Johns Hopkins Bloomberg School of Public Health; Stefan Baral, Johns Hopkins Bloomberg School of Public Health; Kamolnetr Okanurak, Mahidol University; Patrick Sullivan, Emory University; Rachel Valencia, Rollins School of Public Health; Michael C. Thigpen, Thailand Ministry of Public Health; Timothy H. Holtz, Thailand Ministry of Public Health; Philip A. Mock, Thailand Ministry of Public Health; Betsy Cadwell, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; Adeola Adeyeye, National Institute of Allergy and Infectious Diseases (NIAID); James F. Rooney, Gilead Sciences Incorporated; Chris Beyrer, Johns Hopkins Bloomberg School of Public Health
• Language: English
• Date: 2020-01-01
• Publisher: JMIR
• Publication Version: Final Published Version
• Copyright Statement: © Andrea L Wirtz, Brian Wilson Weir, Sandra Hsu Hnin Mon, Pachara Sirivongrangson, Tareerat Chemnasiri, Eileen F Dunne, Anchalee Varangrat, Andrew C Hickey, Michele R Decker, Stefan Baral, Kamolnetr Okanurak, Patrick Sullivan, Rachel Valencia, Michael C Thigpen, Timothy H Holtz, Philip A Mock, Betsy Cadwell, Adeola Adeyeye, James F Rooney, Chris Beyrer, Combination Prevention Effectiveness (COPE) Study Team.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.2196/15354
• Title of Journal or Parent Work: JMIR Research Protocols
• Volume: 9
• Issue: 1
• Start Page: e15354
• End Page: e15354
• Grant/Funding Information: Research reported in this publication is supported by the NIAID of the NIH under Award Number R01AI118505 (PI: Beyrer).; This research has been facilitated by the infrastructure and resources provided by the Johns Hopkins University Center for AIDS Research, an NIH-funded program (P30AI094189), which is supported by the following NIH Co-Funding and Participating Institutes and Centers: NIAID; National Cancer Institute (NCI); National Institute of Child Health and Human Development (NICHD); National Heart, Lung, and Blood Institute (NHLBI); National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH); National Institute on Aging (NIA); Fogarty International Center (FIC); National Institute of General Medical Sciences (NIGMS); National Institute of Diabetes and Digestive and Kidney (NIDDK); and the Office of AIDS Research (OAR).
• Keywords: Thailand; prevention; HIV; cost-effectiveness; sex work; pre-exposure prophylaxis; transgender persons; men who have sex with men
• Research Categories: Health Sciences, Public Health

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 study for young cisgender 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, nonrandomized assessment compares the relative effectiveness of a combination prevention intervention with and without daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada) PrEP with SMS-based adherence support. HIV-uninfected young MSM and TGW aged 18 to 26 years 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 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 4 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 to 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 and 28 TGW) have contributed approximately 168 PY with 95% (73/77) retention at 12 months. 74.2% (330/445) of enrolled participants initiated PrEP at baseline, contributing to 134 PY of PrEP adherence, 1 PY nonadherence, and 33 PY PrEP nonuse/noninitiation. 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 cisgender 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 multilevel, 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.