NCT02775929

Partners Demonstration Project of PrEP and ART

An Open Label, Pilot Demonstration and Evaluation Project of Antiretroviral-based HIV-1 Prevention Among High-risk Serodiscordant African Couples

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,013 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.

Detailed description

An open-label, prospective cohort study of higher-risk HIV-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to ART for HIV-1 infected partners and daily oral PrEP for HIV-1 uninfected partners. The investigators developed a risk score tool to identify couples at highest risk for HIV-1 transmission. PrEP was offered as a 'bridge' to ART in the partnership - i.e., until ART initiation by the HIV-infected partner and for the first 6 months after ART is started; ART was recommended following national ART guidelines. A subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	FTC-TDF PrEP	FTC-TDF PrEP for HIV-1 uninfected partners
DRUG	ART	ART for HIV-1 infected partners

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-05-18
• Last updated: 2017-12-08

Locations

4 sites across 2 countries: Kenya, Uganda