Partners Demonstration Project of PrEP and ART

University of Washington

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Drug: ART; Drug: FTC-TDF PrEP

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02775929

R01MH095507 (U.S. NIH Grant/Contract)

STUDY00001674

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,013 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For couples

• 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

Exclusion criteria

• Otherwise not eligible based on the above inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,013 participants in 1 patient group

PrEP as a bridge to ART

Other group

Description:

FTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners

Treatment:

Drug: ART

Drug: FTC-TDF PrEP