Duo Partnership Adherence Commitment Therapy

NCT ID: NCT02925949

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DuoPACT

A 6-session HIV medication adherence support program for couples.

Group Type ACTIVE_COMPARATOR

DuoPACT

Intervention Type BEHAVIORAL

6 couple-based intervention sessions are administered weekly by a counselor.

LifeSteps

A 3-session HIV medication adherence support program for individuals.

Group Type ACTIVE_COMPARATOR

LifeSteps

Intervention Type BEHAVIORAL

3 individual-based intervention sessions are administered weekly by a counselor.

Interventions

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DuoPACT

6 couple-based intervention sessions are administered weekly by a counselor.

Intervention Type BEHAVIORAL

LifeSteps

3 individual-based intervention sessions are administered weekly by a counselor.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mallory O. Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Center for AIDS Prevention Studies

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33753428 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33753428/

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

Other Identifiers

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2R01NR010187-10A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R01NR010187-10A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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