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 [version 2; referees: 2 approved]

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 deliver...

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Main Authors: Renee Heffron, Kenneth Ngure, Josephine Odoyo, Nulu Bulya, Edna Tindimwebwa, Ting Hong, Lara Kidoguchi, Deborah Donnell, Nelly R. Mugo, Elizabeth A. Bukusi, Elly Katabira, Stephen Asiimwe, Jennifer Morton, Susan Morrison, Harald Haugen, Andrew Mujugira, Jessica E. Haberer, Norma C. Ware, Monique A. Wyatt, Mark A. Marzinke, Lisa M. Frenkel, Connie Celum, Jared M. Baeten, The Partners Demonstration Project Team
Format: Article
Language:English
Published: F1000 Research Ltd 2018-01-01
Series:Gates Open Research
Subjects:
Online Access:https://gatesopenresearch.org/articles/1-3/v2
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author Renee Heffron
Kenneth Ngure
Josephine Odoyo
Nulu Bulya
Edna Tindimwebwa
Ting Hong
Lara Kidoguchi
Deborah Donnell
Nelly R. Mugo
Elizabeth A. Bukusi
Elly Katabira
Stephen Asiimwe
Jennifer Morton
Susan Morrison
Harald Haugen
Andrew Mujugira
Jessica E. Haberer
Norma C. Ware
Monique A. Wyatt
Mark A. Marzinke
Lisa M. Frenkel
Connie Celum
Jared M. Baeten
The Partners Demonstration Project Team
author_facet Renee Heffron
Kenneth Ngure
Josephine Odoyo
Nulu Bulya
Edna Tindimwebwa
Ting Hong
Lara Kidoguchi
Deborah Donnell
Nelly R. Mugo
Elizabeth A. Bukusi
Elly Katabira
Stephen Asiimwe
Jennifer Morton
Susan Morrison
Harald Haugen
Andrew Mujugira
Jessica E. Haberer
Norma C. Ware
Monique A. Wyatt
Mark A. Marzinke
Lisa M. Frenkel
Connie Celum
Jared M. Baeten
The Partners Demonstration Project Team
author_sort Renee Heffron
collection DOAJ
description 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.
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spelling doaj.art-4f9b944f58cb42e99f68901db40ec92e2022-12-22T01:46:03ZengF1000 Research LtdGates Open Research2572-47542018-01-01110.12688/gatesopenres.12752.213860Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa [version 2; referees: 2 approved]Renee Heffron0Kenneth Ngure1Josephine Odoyo2Nulu Bulya3Edna Tindimwebwa4Ting Hong5Lara Kidoguchi6Deborah Donnell7Nelly R. Mugo8Elizabeth A. Bukusi9Elly Katabira10Stephen Asiimwe11Jennifer Morton12Susan Morrison13Harald Haugen14Andrew Mujugira15Jessica E. Haberer16Norma C. Ware17Monique A. Wyatt18Mark A. Marzinke19Lisa M. Frenkel20Connie Celum21Jared M. Baeten22The Partners Demonstration Project TeamDepartment of Epidemiology, University of Washington, Seattle, USACollege of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, KenyaCentres for Microbiology Research , Kenya Medical Research Institute, Nairobi, KenyaInfectious Diseases Institute, Makerere University, Kampala, UgandaKabwohe Clinical Research Center, Kabwohe, UgandaDepartment of Global Health, University of Washington, Seattle, USADepartment of Global Health, University of Washington, Seattle, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USACentres for Clinical Research, Kenya Medical Research Institute, Nairobi, KenyaDepartment of Obstetrics and Gynecology, University of Washington, Seattle, USAInfectious Diseases Institute, Makerere University, Kampala, UgandaKabwohe Clinical Research Center, Kabwohe, UgandaDepartment of Global Health, University of Washington, Seattle, USADepartment of Global Health, University of Washington, Seattle, USADepartment of Global Health, University of Washington, Seattle, USAInfectious Diseases Institute, Makerere University, Kampala, UgandaHarvard Medical School - Massachusetts General Hospital, Boston, USADepartment of Global Health and Social Medicine, Harvard Medical School, Boston, USAHarvard Global, Cambridge, USADepartment of Medicine, Johns Hopkins University, Baltimore, USASeattle Children’s Research Center, Seattle, USADepartment of Epidemiology, University of Washington, Seattle, USADepartment of Epidemiology, University of Washington, Seattle, USABackground: 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.https://gatesopenresearch.org/articles/1-3/v2Health Systems & Services ResearchVirology
spellingShingle Renee Heffron
Kenneth Ngure
Josephine Odoyo
Nulu Bulya
Edna Tindimwebwa
Ting Hong
Lara Kidoguchi
Deborah Donnell
Nelly R. Mugo
Elizabeth A. Bukusi
Elly Katabira
Stephen Asiimwe
Jennifer Morton
Susan Morrison
Harald Haugen
Andrew Mujugira
Jessica E. Haberer
Norma C. Ware
Monique A. Wyatt
Mark A. Marzinke
Lisa M. Frenkel
Connie Celum
Jared M. Baeten
The Partners Demonstration Project Team
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 [version 2; referees: 2 approved]
Gates Open Research
Health Systems & Services Research
Virology
title 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 [version 2; referees: 2 approved]
title_full 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 [version 2; referees: 2 approved]
title_fullStr 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 [version 2; referees: 2 approved]
title_full_unstemmed 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 [version 2; referees: 2 approved]
title_short 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 [version 2; referees: 2 approved]
title_sort 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 version 2 referees 2 approved
topic Health Systems & Services Research
Virology
url https://gatesopenresearch.org/articles/1-3/v2
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