Duo Partnership Adherence Commitment Therapy (DuoPACT)

February 6, 2024 updated by: University of California, San Francisco

A Couples-based Approach to Improving Engagement in HIV Care

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Center for AIDS Prevention Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Mallory O. Johnson, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2017

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimated)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R01NR010187-10A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A de-identified dataset will be made available to investigators upon reasonable request and following completion of primary study analyses.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV/AIDS

Clinical Trials on DuoPACT

  • University of California, San Francisco
    National Institute of Nursing Research (NINR)
    Completed
    DuoPACT Pilot Intervention
    HIV/AIDS
    United States

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe