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Delivery of Integrated PrEP and ART for Couples in Kenya
An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.
PrEP as a bridge to ART strategy will be introduced into 24 Kenyan public HIV-1 care centers according to national guidelines, in staged fashion, stratified by region (a stepped wedge design). Monitoring and evaluation activities will identify implementation barriers and solutions, characterize costs, and provide best practices for further scale-up. A research component will establish prospective open cohorts of couples at each clinic (up to 200) to study how the program is effectively implemented. Follow-up in the cohorts will be for up to 36 months at each care center and will evaluate impact, costs, and facilitators and barriers to implementation at patient, provider and health system levels.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
KEMRI
Kisumu, Kenya
Partners in Health Research and Development
Thika, Kenya
Start Date
February 6, 2017
Primary Completion Date
December 15, 2020
Completion Date
April 30, 2021
Last Updated
October 19, 2021
4,898
ACTUAL participants
Integrated PrEP as a bridge to ART HIV-1 prevention strategy
OTHER
PrEP
DRUG
ART
DRUG
Lead Sponsor
University of Washington
Collaborators
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05668026