Partners Demonstration Project of PrEP and ART

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Bill and Melinda Gates Foundation; National Institute of Mental Health (NIMH); United States Agency for International Development (USAID)

Criteria

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