Duo Partnership Adherence Commitment Therapy

HIV/AIDS Clinical Trial

— DuoPACT  

Official title:

A Couples-based Approach to Improving Engagement in HIV Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925949
• Other study ID #: 2R01NR010187-10A1
• Secondary ID: 2R01NR010187-10A
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• DuoPACT
6 couple-based intervention sessions are administered weekly by a counselor.
• LifeSteps
3 individual-based intervention sessions are administered weekly by a counselor.

Locations

Country	Name	City	State
United States	Center for AIDS Prevention Studies	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tabrisky AP, Coffin LS, Olem DP, Neilands TB, Johnson MO. Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 22;11(3):e037468. doi: 10.1136/bmjopen-2020-037468. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline HIV viral load at 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	Change from Baseline behavioral indicators of engagement in HIV care at 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

External Links

•   Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial