Duo Partnership Adherence Commitment Therapy

NCT02925949 | Completed DMC

• 1 other identifier: 2R01NR010187-10A1
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV/AIDS

Keywords

Treatment; Adherence; Intervention; Sexual and Gender Minority Couples

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline behavioral indicators of engagement in HIV care at 3, 6 and 9 months

  3, 6 and 9 months

Study Arms (2)

DuoPACT

ACTIVE COMPARATOR

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

Behavioral: DuoPACT

LifeSteps

ACTIVE COMPARATOR

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

Behavioral: LifeSteps

Interventions

DuoPACT BEHAVIORAL

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

DuoPACT

LifeSteps BEHAVIORAL

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

LifeSteps

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Sexual and Gender Minorities
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Center for AIDS Prevention Studies

San Francisco, California, 94158, United States

Location

Related 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.

  PMID: 33753428 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Coitus

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexual Behavior; Behavior

Study Officials

• Mallory O. Johnson, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 6, 2016
• Study Start: August 14, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)