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Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa.
Gates Open Res. 2017; 1:3.GO

Abstract

Background:

Pre-exposure prophylaxis (PrEP) can provide high protection against HIV infection and is a recommended intervention for HIV-negative persons with substantial HIV risk. Demonstration projects conducted in diverse settings worldwide illustrate practical examples of how PrEP can be delivered. This manuscript presents estimates of effectiveness and patterns of PrEP use within a two-year demonstration project of PrEP for HIV-negative members of heterosexual HIV serodiscordant couples in East Africa.

Methods:

The PrEP delivery model integrated PrEP into HIV treatment services, prioritizing PrEP use for HIV-negative partners within serodiscordant couples before and during the first 6 months after the partner living with HIV initiated antiretroviral therapy (ART). We measured PrEP uptake through pharmacy records and adherence to PrEP through medication event monitoring system (MEMS) bottle caps and quantification of tenofovir in plasma among a random sample of participants. We estimated HIV infections prevented using a counterfactual cohort simulated from the placebo arm of a previous PrEP clinical trial.

Results:

We enrolled 1,010 HIV serodiscordant couples that were naïve to ART and PrEP. Ninety-seven percent of HIV-negative partners initiated PrEP. Objective measures suggest high adherence: 71% of HIV-negative participants took ≥80% of expected doses, as recorded via MEMS, and 81% of plasma samples had tenofovir detected. Four incident HIV infections were observed (incidence rate=0.24 per 100 person-years), a 95% reduction (95% CI 86-98%, p<0.0001) in HIV incidence, relative to estimated HIV incidence for the population in the absence of PrEP integrated into HIV treatment services.

Conclusions:

PrEP uptake and adherence were high and incident HIV was rare in this PrEP demonstration project for African HIV-negative individuals whose partners were known to be living with HIV. Delivery of PrEP to HIV-negative partners within HIV serodiscordant couples was feasible and should be prioritized for wide-scale implementation.

Authors+Show Affiliations

Department of Epidemiology, University of Washington, Seattle, USA. Department of Global Health, University of Washington, Seattle, USA.College of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.Centres for Microbiology Research , Kenya Medical Research Institute, Nairobi, Kenya.Infectious Diseases Institute, Makerere University, Kampala, Uganda.Kabwohe Clinical Research Center, Kabwohe, Uganda.Department of Global Health, University of Washington, Seattle, USA.Department of Global Health, University of Washington, Seattle, USA.Department of Global Health, University of Washington, Seattle, USA. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USA.Department of Global Health, University of Washington, Seattle, USA. Centres for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.Department of Global Health, University of Washington, Seattle, USA. Centres for Microbiology Research , Kenya Medical Research Institute, Nairobi, Kenya. Department of Obstetrics and Gynecology, University of Washington, Seattle, USA.Infectious Diseases Institute, Makerere University, Kampala, Uganda.Kabwohe Clinical Research Center, Kabwohe, Uganda.Department of Global Health, University of Washington, Seattle, USA.Department of Global Health, University of Washington, Seattle, USA.Department of Global Health, University of Washington, Seattle, USA.Infectious Diseases Institute, Makerere University, Kampala, Uganda.Harvard Medical School - Massachusetts General Hospital, Boston, USA.Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA.Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA. Harvard Global, Cambridge, USA.Department of Medicine, Johns Hopkins University, Baltimore, USA.Seattle Children's Research Center, Seattle, USA. Department of Laboratory Medicine, University of Washington, Seattle, USA. Department of Pediatrics, University of Washington, Seattle, USA.Department of Epidemiology, University of Washington, Seattle, USA. Department of Global Health, University of Washington, Seattle, USA. Department of Medicine, University of Washington, Seattle, USA.Department of Epidemiology, University of Washington, Seattle, USA. Department of Global Health, University of Washington, Seattle, USA. Department of Medicine, University of Washington, Seattle, USA.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29355231

Citation

Heffron, Renee, et al. "Pre-exposure Prophylaxis for HIV-negative Persons With Partners Living With HIV: Uptake, Use, and Effectiveness in an Open-label Demonstration Project in East Africa." Gates Open Research, vol. 1, 2017, p. 3.
Heffron R, Ngure K, Odoyo J, et al. Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa. Gates Open Res. 2017;1:3.
Heffron, R., Ngure, K., Odoyo, J., Bulya, N., Tindimwebwa, E., Hong, T., Kidoguchi, L., Donnell, D., Mugo, N. R., Bukusi, E. A., Katabira, E., Asiimwe, S., Morton, J., Morrison, S., Haugen, H., Mujugira, A., Haberer, J. E., Ware, N. C., Wyatt, M. A., ... Baeten, J. M. (2017). Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa. Gates Open Research, 1, 3. https://doi.org/10.12688/gatesopenres.12752.2
Heffron R, et al. Pre-exposure Prophylaxis for HIV-negative Persons With Partners Living With HIV: Uptake, Use, and Effectiveness in an Open-label Demonstration Project in East Africa. Gates Open Res. 2017;1:3. PubMed PMID: 29355231.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa. AU - Heffron,Renee, AU - Ngure,Kenneth, AU - Odoyo,Josephine, AU - Bulya,Nulu, AU - Tindimwebwa,Edna, AU - Hong,Ting, AU - Kidoguchi,Lara, AU - Donnell,Deborah, AU - Mugo,Nelly R, AU - Bukusi,Elizabeth A, AU - Katabira,Elly, AU - Asiimwe,Stephen, AU - Morton,Jennifer, AU - Morrison,Susan, AU - Haugen,Harald, AU - Mujugira,Andrew, AU - Haberer,Jessica E, AU - Ware,Norma C, AU - Wyatt,Monique A, AU - Marzinke,Mark A, AU - Frenkel,Lisa M, AU - Celum,Connie, AU - Baeten,Jared M, AU - ,, Y1 - 2018/01/30/ PY - 2018/01/29/accepted PY - 2019/9/25/entrez PY - 2018/1/30/pubmed PY - 2018/1/30/medline KW - ART KW - HIV prevention KW - HIV serodiscordant couples KW - PrEP SP - 3 EP - 3 JF - Gates open research JO - Gates Open Res VL - 1 N2 - Background: Pre-exposure prophylaxis (PrEP) can provide high protection against HIV infection and is a recommended intervention for HIV-negative persons with substantial HIV risk. Demonstration projects conducted in diverse settings worldwide illustrate practical examples of how PrEP can be delivered. This manuscript presents estimates of effectiveness and patterns of PrEP use within a two-year demonstration project of PrEP for HIV-negative members of heterosexual HIV serodiscordant couples in East Africa. Methods: The PrEP delivery model integrated PrEP into HIV treatment services, prioritizing PrEP use for HIV-negative partners within serodiscordant couples before and during the first 6 months after the partner living with HIV initiated antiretroviral therapy (ART). We measured PrEP uptake through pharmacy records and adherence to PrEP through medication event monitoring system (MEMS) bottle caps and quantification of tenofovir in plasma among a random sample of participants. We estimated HIV infections prevented using a counterfactual cohort simulated from the placebo arm of a previous PrEP clinical trial. Results: We enrolled 1,010 HIV serodiscordant couples that were naïve to ART and PrEP. Ninety-seven percent of HIV-negative partners initiated PrEP. Objective measures suggest high adherence: 71% of HIV-negative participants took ≥80% of expected doses, as recorded via MEMS, and 81% of plasma samples had tenofovir detected. Four incident HIV infections were observed (incidence rate=0.24 per 100 person-years), a 95% reduction (95% CI 86-98%, p<0.0001) in HIV incidence, relative to estimated HIV incidence for the population in the absence of PrEP integrated into HIV treatment services. Conclusions: PrEP uptake and adherence were high and incident HIV was rare in this PrEP demonstration project for African HIV-negative individuals whose partners were known to be living with HIV. Delivery of PrEP to HIV-negative partners within HIV serodiscordant couples was feasible and should be prioritized for wide-scale implementation. SN - 2572-4754 UR - https://www.unboundmedicine.com/medline/citation/29355231/Pre_exposure_prophylaxis_for_HIV_negative_persons_with_partners_living_with_HIV:_uptake_use_and_effectiveness_in_an_open_label_demonstration_project_in_East_Africa_ L2 - https://gatesopenresearch.org/articles/10.12688/gatesopenres.12752.2/doi DB - PRIME DP - Unbound Medicine ER -
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