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PLoS Med. 2016 Aug 23;13(8):e1002099. doi: 10.1371/journal.pmed.1002099. eCollection 2016 Aug.

Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda.

Author information

1
Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America.
2
Department of Medicine, University of Washington, Seattle, Seattle, Washington, United States of America.
3
Department of Epidemiology, University of Washington, Seattle, Seattle, Washington, United States of America.
4
Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
5
Infectious Disease Institute, Makerere University, Kampala, Uganda.
6
Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.
7
Kabwohe Clinical Research Center, Kabwohe, Uganda.
8
Massachusetts General Hospital, Boston, Massachusetts, United States of America.
9
College of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
10
Department of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America.
11
Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, United States of America.
12
Harvard Global, Cambridge, Massachusetts, United States of America.
13
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.

Abstract

BACKGROUND:

Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings.

METHODS AND FINDINGS:

Between November 5, 2012, and January 5, 2015, we enrolled and followed 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP.

CONCLUSIONS:

Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

PMID:
27552090
PMCID:
PMC4995047
DOI:
10.1371/journal.pmed.1002099
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

All authors have read the journal's policy and have the following competing interests: Gilead Sciences donated the PrEP medication used in this study. CH received prior funding (05/01/09-04/30/10) for a pharmacokinetics study of TDF in the colon and female genital tract from Gilead Sciences and has a patent pending using a different formulation of the drug used in this study.

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