HIV/AIDS
Conditions
Keywords
Treatment, Adherence, Intervention, Sexual and Gender Minority Couples
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.
Interventions
Sponsors
National Institute of Nursing Research (NINR)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18+ years old; 2. Identifies as a sexual or gender minority; 3. In a primary romantic relationship for at least 3 months; 4. At least one partner is HIV+; 5. English-speaking; 6. Able to provide informed consent; and 7. For HIV+ participants: Evidence of suboptimal engagement in HIV care.
Exclusion criteria
1. Must be able to consent to and follow study protocol; 2. Evidence of severe cognitive impairment or active psychosis; 3. Lives outside California or plans to relocate from the state of California in the next 6 months; or 4. Participation in the DuoPACT pilot.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline HIV viral load at 3, 6 and 9 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline behavioral indicators of engagement in HIV care at 3, 6 and 9 months | 3, 6 and 9 months | The investigators will use a newly developed 8-point scale called the Behavioral Composite of Engagement in HIV Care, which integrates: * Current/past ART use (participant self-report and verification by HIV medication pill bottles or current pharmacy prescription). * HIV appointment attendance (participant self-report categorized according to current HRSA standards of the minimum annual number and spacing of HIV primary care appointments). * ART adherence (participant self-report and Walsh visual analog scale), * Knowledge of current CD4 cell count (participant self-report). |
Countries
United States
Outcome results
None listed