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 : August 13, 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).
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
|Contact: Lara Coffin, MPHfirstname.lastname@example.org|
|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|