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Duo Partnership Adherence Commitment Therapy (DuoPACT)

This study is currently recruiting participants.
Verified August 2017 by Mallory O. Johnson, University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02925949
First Posted: October 6, 2016
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mallory O. Johnson, University of California, San Francisco
  Purpose
This is a randomized controlled trial of a new behavioral intervention designed to improve engagement in HIV care for same-sex male 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).

Condition Intervention
HIV/AIDS Behavioral: DuoPACT Behavioral: LifeSteps

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Couples-based Approach to Improving Engagement in HIV Care

Resource links provided by NLM:


Further study details as provided by Mallory O. Johnson, University of California, San Francisco:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).


Estimated Enrollment: 300
Actual Study Start Date: August 14, 2017
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
The investigators will test the intervention to improve HIV care engagement by enrolling 150 same-sex male 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18+ years old;
  2. Assigned male sex at birth and currently identifies as male;
  3. In a primary romantic relationship with another man 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+ men: 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925949


Contacts
Contact: Lara Coffin, MPH 415-502-5216 lara.coffin@ucsf.edu

Locations
United States, California
Center for AIDS Prevention Studies Recruiting
San Francisco, California, United States, 94158
Contact: Lara Coffin    415-502-5216      
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mallory O. Johnson, PhD University of California, San Francisco
  More Information

Responsible Party: Mallory O. Johnson, Co-Director, CAPS, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02925949     History of Changes
Other Study ID Numbers: 2R01NR010187-10A1 ( U.S. NIH Grant/Contract )
First Submitted: September 28, 2016
First Posted: October 6, 2016
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mallory O. Johnson, University of California, San Francisco:
Treatment
Adherence
Intervention
MSM Couples