A Couples-based Approach to Improving Engagement in HIV Care
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- University of California, San Francisco
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- Change from Baseline HIV viral load at 3, 6 and 9 months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a randomized controlled trial of a new behavioral intervention designed to improve engagement in HIV care for couples. Investigators will compare the HIV viral load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to an individual adherence intervention (LifeSteps).
Detailed Description
The investigators will test the intervention to improve HIV care engagement by enrolling 150 sexual or gender minority couples and randomizing 75 couples each to one of two conditions: 1) DuoPACT, a newly-developed couples intervention; or 2) LifeSteps, a standardized antiretroviral adherence intervention for HIV+ individuals. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention effects via behavioral indicators of engagement in HIV care, the couple's relationship dynamics, and the primary outcome of HIV viral load.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18+ years old;
- •Identifies as a sexual or gender minority;
- •In a primary romantic relationship for at least 3 months;
- •At least one partner is HIV+;
- •English-speaking;
- •Able to provide informed consent; and
- •For HIV+ participants: Evidence of suboptimal engagement in HIV care.
Exclusion Criteria
- •Must be able to consent to and follow study protocol;
- •Evidence of severe cognitive impairment or active psychosis;
- •Lives outside California or plans to relocate from the state of California in the next 6 months; or
- •Participation in the DuoPACT pilot.
Outcomes
Primary Outcomes
Change from Baseline HIV viral load at 3, 6 and 9 months
Time Frame: 3, 6 and 9 months
Follow-up blood draws will be performed on all HIV+ partners at 3, 6, and 9 months post randomization. HIV-1 viral load levels will be measured by the COBAS® AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.), which has a threshold for undetectability = \< 20 copies/mL.
Secondary Outcomes
- Change from Baseline behavioral indicators of engagement in HIV care at 3, 6 and 9 months(3, 6 and 9 months)