TY - JOUR
T1 - HPTN 067/ADAPT
T2 - Correlates of Sex-Related Pre-exposure Prophylaxis Adherence, Thai Men Who Have Sex with Men, and Transgender Women, 2012-2013
AU - Holtz, Timothy H.
AU - Chitwarakorn, Anupong
AU - Hughes, James P.
AU - Curlin, Marcel E.
AU - Varangrat, Anchalee
AU - Li, Maoji
AU - Amico, K. Rivet
AU - Mock, Philip A.
AU - Grant, Robert M.
N1 - Funding Information:
Supported by the HIV Prevention Trials Network (HPTN), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the Office of AIDS Research of the National Institutes of Health (NIH), Department of Health and Human Services (DHHS) [Grant numbers UM1AI068613, UM1AI068617, and UM1AI068619]. Gilead Sciences donated study medication to the NIH to support this study. This work was also supported in part by the Emory-CDC HIV/AIDS Clinical Trials Unit Grant award number UM1AI069418 from the NIH (NIAID). The funder of the study reviewed and commented on the study protocol and final manuscript written by the study investigators. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The study sponsor reviewed and approved of the study protocol and of this article. The study sponsor had no role in the analysis or interpretation of the data or in writing of this article.
Funding Information:
Supported by the HIV Prevention Trials Network (HPTN), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the Office of AIDS Research of the National Institutes of Health (NIH), Department of Health and Human Services (DHHS) [Grant numbers UM1AI068613, UM1AI068617, and UM1AI068619]. Gilead Sciences donated study medication to the NIH to support this study. This work was also supported in part by the Emory-CDC HIV/AIDS Clinical Trials Unit Grant award number UM1AI069418 from the NIH (NIAID). The funder of the study reviewed and commented on the study protocol and final manuscript written by the study investigators. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The study sponsor reviewed and approved of the study protocol and of this article. The study sponsor had no role in the analysis or interpretation of the data or in writing of this article.
Publisher Copyright:
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/10/1
Y1 - 2019/10/1
N2 - Background: We identified correlates of sex-related pre-exposure prophylaxis (PrEP) adherence in HPTN067/ADAPT, a phase 2, open-label feasibility study of daily and nondaily regimens of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)-based PrEP, among Thai men who have sex with men (MSM), and transgender women (TGW), Bangkok. Methods: Participants were randomly assigned to one of three self-administered dosing regimens for 24 weeks: daily, time-driven, or event-driven. Demographic and behavioral information was obtained at screening. Pill-container opening was recorded with electronic dose monitoring, and self-reported information on PrEP use, sex events, and substance use was obtained during weekly interviews to confirm dose data. Sex-related PrEP adherence was calculated as the proportion of sex events covered by PrEP use (at least one tablet taken within 4 days before sex and at least one tablet taken within 24 hours after sex) to total sex events. We used multivariate modeling with sex event as the unit of analysis to evaluate correlates associated with sex-related PrEP adherence. Results: Among 178 MSM and TGW, sex-related PrEP adherence was similar in the daily and time-driven arms (P = 0.79), both significantly greater than the event-driven arm (P = 0.02 compared to daily). Sex-related PrEP adherence by those reporting stimulant use (74.2%) was similar to those reporting other nonalcohol drug use (76.3%, P = 0.80), but lower than those reporting no substance use (84.6%, P = 0.04). In a multivariable model, randomization to the event-driven arm, a higher prestudy number of reported sex events, and use of stimulant drugs were associated with significantly lower sex-related PrEP adherence.Conclusion: Adherence was influenced by treatment schedule and adversely affected by nonalcoholic substance use. Regardless of these factors, Thai MSM and TGW maintained high adherence levels to oral PrEP dosing regimens and coverage of sexual exposures.
AB - Background: We identified correlates of sex-related pre-exposure prophylaxis (PrEP) adherence in HPTN067/ADAPT, a phase 2, open-label feasibility study of daily and nondaily regimens of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)-based PrEP, among Thai men who have sex with men (MSM), and transgender women (TGW), Bangkok. Methods: Participants were randomly assigned to one of three self-administered dosing regimens for 24 weeks: daily, time-driven, or event-driven. Demographic and behavioral information was obtained at screening. Pill-container opening was recorded with electronic dose monitoring, and self-reported information on PrEP use, sex events, and substance use was obtained during weekly interviews to confirm dose data. Sex-related PrEP adherence was calculated as the proportion of sex events covered by PrEP use (at least one tablet taken within 4 days before sex and at least one tablet taken within 24 hours after sex) to total sex events. We used multivariate modeling with sex event as the unit of analysis to evaluate correlates associated with sex-related PrEP adherence. Results: Among 178 MSM and TGW, sex-related PrEP adherence was similar in the daily and time-driven arms (P = 0.79), both significantly greater than the event-driven arm (P = 0.02 compared to daily). Sex-related PrEP adherence by those reporting stimulant use (74.2%) was similar to those reporting other nonalcohol drug use (76.3%, P = 0.80), but lower than those reporting no substance use (84.6%, P = 0.04). In a multivariable model, randomization to the event-driven arm, a higher prestudy number of reported sex events, and use of stimulant drugs were associated with significantly lower sex-related PrEP adherence.Conclusion: Adherence was influenced by treatment schedule and adversely affected by nonalcoholic substance use. Regardless of these factors, Thai MSM and TGW maintained high adherence levels to oral PrEP dosing regimens and coverage of sexual exposures.
KW - HIV
KW - PrEP
KW - Thailand
KW - event-driven
KW - men who have sex with men
UR - http://www.scopus.com/inward/record.url?scp=85072134470&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85072134470&partnerID=8YFLogxK
U2 - 10.1097/QAI.0000000000002131
DO - 10.1097/QAI.0000000000002131
M3 - Article
C2 - 31490342
AN - SCOPUS:85072134470
SN - 1525-4135
VL - 82
SP - E18-E26
JO - Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology
JF - Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology
IS - 2
ER -