Duo Partnership Adherence Commitment Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Couples-based Approach to Improving Engagement in HIV Care

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: DuoPACT
* Behavioral: LifeSteps


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DuoPACT<br>A 6-session HIV medication adherence support program for couples. | Behavioral: DuoPACT<br>* 6 couple-based intervention sessions are administered weekly by a counselor.<br>|
| Active Comparator: LifeSteps<br>A 3-session HIV medication adherence support program for individuals. | Behavioral: LifeSteps<br>* 3 individual-based intervention sessions are administered weekly by a counselor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HIV viral load at 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. | 3, 6 and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline behavioral indicators of engagement in HIV care at 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). | 3, 6 and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, Adherence, Intervention, Sexual and Gender Minority Couples