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
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: DuoPACT Behavioral: LifeSteps||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
Active Comparator: DuoPACT
A 6-session HIV medication adherence support program for couples.
6 couple-based intervention sessions are administered weekly by a counselor.
Active Comparator: LifeSteps
A 3-session HIV medication adherence support program for individuals.
3 individual-based intervention sessions are administered weekly by a counselor.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925949
|Contact: Lara Coffin, MPHemail@example.com|
|United States, California|
|Center for AIDS Prevention Studies||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Lara Coffin 415-502-5216|
|Principal Investigator:||Mallory O. Johnson, PhD||University of California, San Francisco|