Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1013 participants
INTERVENTIONAL
2012-11-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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PrEP as a bridge to ART
FTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners
FTC-TDF PrEP
FTC-TDF PrEP for HIV-1 uninfected partners
ART
ART for HIV-1 infected partners
Interventions
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FTC-TDF PrEP
FTC-TDF PrEP for HIV-1 uninfected partners
ART
ART for HIV-1 infected partners
Eligibility Criteria
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Inclusion Criteria
* Risk score defining higher HIV-1 risk (≥6)
* Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
* Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
* Did not participate in the Partners PrEP Study
For HIV-1 uninfected members of the couple (partner participants)
* Age ≥18
* Able and willing to provide written informed consent
* HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
* Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance \>60 mL/min
* Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
* Not currently pregnant or breastfeeding
* Not currently enrolled in an HIV-1 prevention clinical trial
* Not currently using PrEP
* Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator
For HIV-1 infected members of the couple (index participants)
* Age ≥18
* Able and willing to provide written informed consent
* HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
* No history of WHO stage III or IV conditions
* Not currently using ART
* Not currently enrolled in an HIV-1 treatment study
* Note: current pregnancy and breastfeeding are permitted for HIV-1 infected partners
18 Years
ALL
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
National Institute of Mental Health (NIMH)
NIH
United States Agency for International Development (USAID)
FED
University of Washington
OTHER
Responsible Party
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Jared Baeten
Professor, Global Health, Medicine, & Epidemiology
Principal Investigators
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Jared M Baeten, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Kemri-Ucsf
Kisumu, , Kenya
Partners in Prevention-Thika
Thika, , Kenya
Kabwohe Clinical Research Center
Bushenyi, , Uganda
Partners in Prevention-Infectious Diseases Institute LTD
Kampala, , Uganda
Countries
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References
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Nakku-Joloba E, Pisarski EE, Wyatt MA, Muwonge TR, Asiimwe S, Celum CL, Baeten JM, Katabira ET, Ware NC. Beyond HIV prevention: everyday life priorities and demand for PrEP among Ugandan HIV serodiscordant couples. J Int AIDS Soc. 2019 Jan;22(1):e25225. doi: 10.1002/jia2.25225.
Other Identifiers
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STUDY00001674
Identifier Type: -
Identifier Source: org_study_id