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Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda.
PLoS Med. 2016 08; 13(8):e1002099.PM

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.

Authors+Show Affiliations

Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America. Department of Medicine, University of Washington, Seattle, Seattle, Washington, United States of America. Department of Epidemiology, University of Washington, Seattle, Seattle, Washington, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America. Department of Epidemiology, University of Washington, Seattle, Seattle, Washington, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America. Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.Infectious Disease Institute, Makerere University, Kampala, Uganda.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America. Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.Kabwohe Clinical Research Center, Kabwohe, Uganda.Massachusetts General Hospital, Boston, Massachusetts, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America.College of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.Infectious Disease Institute, Makerere University, Kampala, Uganda.Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.Kabwohe Clinical Research Center, Kabwohe, Uganda.Department of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America.Department of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America.Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, United States of America.Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, United States of America. Harvard Global, Cambridge, Massachusetts, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.Department of Global Health, University of Washington, Seattle, Seattle, Washington, United States of America. Department of Medicine, University of Washington, Seattle, Seattle, Washington, United States of America. Department of Epidemiology, University of Washington, Seattle, Seattle, Washington, United States of America.No affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

27552090

Citation

Baeten, Jared M., et al. "Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: a Prospective Implementation Study in Kenya and Uganda." PLoS Medicine, vol. 13, no. 8, 2016, pp. e1002099.
Baeten JM, Heffron R, Kidoguchi L, et al. Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda. PLoS Med. 2016;13(8):e1002099.
Baeten, J. M., Heffron, R., Kidoguchi, L., Mugo, N. R., Katabira, E., Bukusi, E. A., Asiimwe, S., Haberer, J. E., Morton, J., Ngure, K., Bulya, N., Odoyo, J., Tindimwebwa, E., Hendrix, C., Marzinke, M. A., Ware, N. C., Wyatt, M. A., Morrison, S., Haugen, H., ... Celum, C. (2016). Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda. PLoS Medicine, 13(8), e1002099. https://doi.org/10.1371/journal.pmed.1002099
Baeten JM, et al. Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: a Prospective Implementation Study in Kenya and Uganda. PLoS Med. 2016;13(8):e1002099. PubMed PMID: 27552090.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda. AU - Baeten,Jared M, AU - Heffron,Renee, AU - Kidoguchi,Lara, AU - Mugo,Nelly R, AU - Katabira,Elly, AU - Bukusi,Elizabeth A, AU - Asiimwe,Stephen, AU - Haberer,Jessica E, AU - Morton,Jennifer, AU - Ngure,Kenneth, AU - Bulya,Nulu, AU - Odoyo,Josephine, AU - Tindimwebwa,Edna, AU - Hendrix,Craig, AU - Marzinke,Mark A, AU - Ware,Norma C, AU - Wyatt,Monique A, AU - Morrison,Susan, AU - Haugen,Harald, AU - Mujugira,Andrew, AU - Donnell,Deborah, AU - Celum,Connie, AU - ,, Y1 - 2016/08/23/ PY - 2015/10/26/received PY - 2016/06/17/accepted PY - 2016/8/24/entrez PY - 2016/8/24/pubmed PY - 2017/5/27/medline SP - e1002099 EP - e1002099 JF - PLoS medicine JO - PLoS Med. VL - 13 IS - 8 N2 - 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. SN - 1549-1676 UR - https://www.unboundmedicine.com/medline/citation/27552090/Integrated_Delivery_of_Antiretroviral_Treatment_and_Pre_exposure_Prophylaxis_to_HIV_1_Serodiscordant_Couples:_A_Prospective_Implementation_Study_in_Kenya_and_Uganda_ L2 - http://dx.plos.org/10.1371/journal.pmed.1002099 DB - PRIME DP - Unbound Medicine ER -