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Duo Partnership Adherence Commitment Therapy (DuoPACT)

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ClinicalTrials.gov Identifier: NCT02925949
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Mallory O. Johnson, 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 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 or disease Intervention/treatment
HIV/AIDS Behavioral: DuoPACT Behavioral: LifeSteps

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 :
  1. 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).



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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.
  3. Plans to relocate from Bay Area in the next 6 months.

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

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 Posted: October 6, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
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