Duo Partnership Adherence Commitment Therapy

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: LifeSteps; Behavioral: DuoPACT

• Registration Number: NCT02925949
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Study Start: 2017-08-14
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LifeSteps	LifeSteps	A 3-session HIV medication adherence support program for individuals.
DuoPACT	DuoPACT	A 6-session HIV medication adherence support program for couples.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Center for AIDS Prevention Studies; 🇺🇸 San Francisco, California, United States