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The Effect of Depression on Adherence to HIV Pre-exposure Prophylaxis Among High-Risk South African Women in HPTN 067/ADAPT

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Abstract

Oral pre-exposure prophylaxis (PrEP) is highly efficacious but low adherence undermines effectiveness. Depression, common in African women, may be a barrier to consistent PrEP use. We aimed to assess the relationship between depression, psychosocial mediators, and PrEP adherence among South African women. We analyzed data from 174 South African women in HPTN 067, an open-label oral PrEP trial conducted from 2011 to 2013. Participants were followed for 24 weeks. PrEP adherence was measured via Wisepill™ and weekly self-report interview data. We considered participants “adherent” at week 24 if Wisepill™ and interviews indicated that ≥ 80% of expected doses were taken in the prior month. Elevated depressive symptoms were assessed using the 20-item Center for Epidemiological Studies-Depression (CES-D) scale. We used marginal structural models to estimate the effect of elevated symptoms at baseline on PrEP adherence at week 24 and to assess whether the direct effect changed meaningfully after accounting for mediating effects of stigma, social support, and PrEP optimism. High PrEP adherence occurred less often among women with elevated depressive symptoms (N = 35; 44.3%) compared with those without (N = 52; 54.7%; adjusted relative risk [aRR]: 0.79; 95% confidence interval [CI] 0.63–0.99). The effect of elevated depressive symptoms on PrEP adherence persisted in models accounting for the mediating influence of stigma (aRR: 0.74; 95% CI 0.51–0.97) and PrEP optimism (aRR: 0.75; 95% CI 0.55–0.99). We also found a direct effect of similar magnitude and direction when accounting for social support as the mediating variable, although this adjusted relative risk estimate was not statistically significant (aRR: 0.77; 95% CI 0.57–1.03). Depressive symptoms were common and associated with lower PrEP adherence among South African women. Future work is needed to determine whether depression services integrated with PrEP delivery could improve PrEP effectiveness among African women.

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Acknowledgements

The authors thank the individuals who participated in the study, the team at the Emavundleni Clinical Research Site in Cape Town, South Africa, and the HIV Prevention Trials Network that supported data collection and management for this work.

Funding

This work was supported by award numbers UM1-AI068619, UM1-AI068617, UM1-AI068613, and R01 AI118575, from the NIH (National Institute of Allergy and Infectious Diseases [NIAID], National Institute of Mental Health [NIMH], and National Institute on Drug Abuse [NIDA]) to HPTN. This work was also supported in part by the Emory-CDC HIV/AIDS Clinical Trials Unit award number UM1AI069418 from the NIH (NIAID). JV was supported by the NIMH of the NIH (Grant F31 MH113420). Gilead Sciences donated study medication to the NIH to support this study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID, the National Institutes of Health, or the U.S. Centers for Disease Control and Prevention. The use of a trademark name herein does not indicate government endorsement.

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Correspondence to Jennifer Velloza.

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Conflict of interest

RMG has been a site investigator for clinical trials funded by GlaxoSmithKline (GSK; managed by ViiV Healthcare) and Gilead Sciences to the Gladstone Institutes and the San Francisco AIDS Foundation. KRA received an unrestricted educational grant to the University of Michigan from Gilead Sciences (2015–2017). All other authors report no potential conflicts of interest.

Ethical Approval

Ethical approval was obtained by the Human Research Ethics Committee (HREC) in South Africa and the protocol was reviewed by the National Institutes of Health (NIH) Division of AIDS (DAIDS) prior to implementation. Participants provided written informed consent in their preferred language. The protocol was registered at ClinicalTrials.gov (identifier NCT01327651).

Research Involving Human Participants and/or Animals

All procedures performed were in accordance with the ethical standards of the Human Research Ethics Committee (HREC) in South Africa and the National Institutes of Health (NIH) Division of AIDS (DAIDS), national research ethics committees for the study site, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Velloza, J., Heffron, R., Amico, K.R. et al. The Effect of Depression on Adherence to HIV Pre-exposure Prophylaxis Among High-Risk South African Women in HPTN 067/ADAPT. AIDS Behav 24, 2178–2187 (2020). https://doi.org/10.1007/s10461-020-02783-8

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