Duo Partnership Adherence Commitment Therapy (DuoPACT)
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DuoPACT
LifeSteps
Sponsored by
About this trial
This is an interventional supportive care trial for HIV/AIDS focused on measuring Treatment, Adherence, Intervention, Sexual and Gender Minority Couples
Eligibility Criteria
Inclusion Criteria:
- 18+ years old;
- Identifies as a sexual or gender minority;
- In a primary romantic relationship for at least 3 months;
- At least one partner is HIV+;
- English-speaking;
- Able to provide informed consent; and
- For HIV+ participants: Evidence of suboptimal engagement in HIV care.
Exclusion Criteria:
- Must be able to consent to and follow study protocol;
- Evidence of severe cognitive impairment or active psychosis;
- Lives outside California or plans to relocate from the state of California in the next 6 months; or
- Participation in the DuoPACT pilot.
Sites / Locations
- Center for AIDS Prevention Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
DuoPACT
LifeSteps
Arm Description
A 6-session HIV medication adherence support program for couples.
A 3-session HIV medication adherence support program for individuals.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02925949
First Posted
September 28, 2016
Last Updated
August 14, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT02925949
Brief Title
Duo Partnership Adherence Commitment Therapy
Acronym
DuoPACT
Official Title
A Couples-based Approach to Improving Engagement in HIV Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Treatment, Adherence, Intervention, Sexual and Gender Minority Couples
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DuoPACT
Arm Type
Active Comparator
Arm Description
A 6-session HIV medication adherence support program for couples.
Arm Title
LifeSteps
Arm Type
Active Comparator
Arm Description
A 3-session HIV medication adherence support program for individuals.
Intervention Type
Behavioral
Intervention Name(s)
DuoPACT
Intervention Description
6 couple-based intervention sessions are administered weekly by a counselor.
Intervention Type
Behavioral
Intervention Name(s)
LifeSteps
Intervention Description
3 individual-based intervention sessions are administered weekly by a counselor.
Primary Outcome Measure Information:
Title
Change from Baseline HIV viral load at 3, 6 and 9 months
Description
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.
Time Frame
3, 6 and 9 months
Secondary Outcome Measure Information:
Title
Change from Baseline behavioral indicators of engagement in HIV care at 3, 6 and 9 months
Description
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).
Time Frame
3, 6 and 9 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Sexual and Gender Minorities
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18+ years old;
Identifies as a sexual or gender minority;
In a primary romantic relationship for at least 3 months;
At least one partner is HIV+;
English-speaking;
Able to provide informed consent; and
For HIV+ participants: Evidence of suboptimal engagement in HIV care.
Exclusion Criteria:
Must be able to consent to and follow study protocol;
Evidence of severe cognitive impairment or active psychosis;
Lives outside California or plans to relocate from the state of California in the next 6 months; or
Participation in the DuoPACT pilot.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mallory O. Johnson, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for AIDS Prevention Studies
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
A de-identified dataset will be made available to investigators upon reasonable request and following completion of primary study analyses.
Citations:
PubMed Identifier
33753428
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/33753428/
Description
Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial
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Duo Partnership Adherence Commitment Therapy
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