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Low Disclosure of PrEP Nonadherence and HIV-Risk Behaviors Associated With Poor HIV PrEP Adherence in the HPTN 067/ADAPT Study

Ojeda, Victoria D. PhD, MPHa; Amico, K. Rivet PhDb; Hughes, James P. PhDc; Wilson, Ethan MSd; Li, Maoji MSd; Holtz, Timothy H. MD, MPHe,f; Chitwarakorn, Anupong MDg; Grant, Robert M. MD, MPHh; Dye, Bonnie J. MPHi; Bekker, Linda-Gail MD, PhDj; Mannheimer, Sharon MDk,l,m; Marzinke, Mark PhDn,o; Hendrix, Craig W. MDo

JAIDS Journal of Acquired Immune Deficiency Syndromes: September 1, 2019 - Volume 82 - Issue 1 - p 34–40
doi: 10.1097/QAI.0000000000002103
Prevention Research

Objective: We evaluated the relationship between 2 types of social relationships, ie, (1) external support for use of HIV pre-exposure prophylaxis (PrEP) and related study supplies and (2) participants' disclosure of PrEP use and condom use and HIV PrEP adherence among daily-dosing regimen participants in HIV Prevention Trials Network (HPTN) 067, an open-label trial of oral tenofovir (TFV) disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg.

Methods: Using HPTN 067 survey data, we developed scales examining (1) Low Perceived External Support for PrEP: low perceived support by others for PrEP use or perceived negative reactions to the pill case (scoring ranges from 0 to 2) and (2) Participant–Staff Disclosure Challenges Scale, which identifies challenges to sharing nonuse of PrEP or condoms to study staff (scoring ranges from 0 to 4); these scales are the primary independent variables. Adherence, the dependent variable, was determined using log-transformed plasma TFV concentrations. generalized estimating equation (GEE) linear regression was used to assess the association between both scales and adherence.

Results: Participants (n = 161) included HIV-uninfected women in South Africa, and men who have sex with men and transgender women, in Thailand and the United States. In multivariable analyses, higher scores in the Participant–Staff Disclosure Challenges Scale were significantly associated with lower PrEP adherence [exp(β) = 0.62, 95% CI: (0.46 to 0.84); P = 0.002] as were increased days since the last PrEP dose [exp(β) = 0.73, 95% CI: (0.65 to 0.83); P ≤ 0.001].

Conclusions: Given the association with adherence, study staff–participant interactions and participants' disclosure of PrEP challenges may be worthwhile intervention targets for improving PrEP adherence in confirmatory studies.

aDepartment of Medicine, UCSD School of Medicine, La Jolla, CA;

bDepartment of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI;

cDepartment of Biostatistics, University of Washington, Seattle, WA;

dStatistical Center for AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA;

eThailand Ministry of Public Health—U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand;

fDivision of HIV/AIDS Prevention, U.S. Centers for Disease Control and Prevention, Atlanta, GA;

gDepartment of Disease Control, Ministry of Public Health, Nonthaburi, Thailand;

hGladstone Institutes, University of California, San Francisco, CA;

iHIV Prevention Trials Network, FHI 360, Durham, NC;

jThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa;

kDepartment of Medicine, Harlem Hospital Center, New York, NY;

lDepartment of Epidemiology, Columbia University Mailman School of Public Health, New York, NY;

mICAP, Columbia University Mailman School of Public Health, New York, NY; and

Departments of nPathology; and

oMedicine (Clinical Pharmacology), Johns Hopkins University, Baltimore, MD.

Correspondence to: Victoria D. Ojeda, PhD, Department of Medicine, UCSD School of Medicine, 9500 Gilman Drive MC-0725, La Jolla, CA 92093-0725 (e-mail:

The HIV Prevention Trials Network is sponsored by the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, and the National Institute on Drug Abuse, all components of the US National Institutes of Health. The HPTN 067 Study Team acknowledges the contributions by participants in Cape Town, Bangkok, and Harlem, NIH-funded HIV Prevention Trials Network, and the HPTN Scholars Network. This publication also resulted in part from research supported by the University of California, San Diego, Center for AIDS Research (CFAR), an NIH-funded program (P30AI036214), which is supported by the following NIH Institutes and Centers: NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, NIA, NIGMS, and NIDDK. This research was also funded in part 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, NCI, NICHD, NHLBI, NIDA, NIMH, NIA, FIC, NIGMS, NIDDK, and OAR. This work was supported in part by the Emory-CDC HIV/AIDS Clinical Trials Unit award number UM1AI069418 from the NIH (NIAID). The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official position of the funding agency, the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry, or the United States Department of Health and Human Services.

Presented at Twelfth International Conference on HIV Treatment and Prevention Adherence; June 4–6, 2017 and National Hispanic Science Network Annual Conference; October 5, 2017; Phoenix, AZ.

The authors have no conflicts of interest to disclose.

Received January 13, 2019

Accepted April 10, 2019

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