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Completed

NCT Number: NCT02925949

Duo Partnership Adherence Commitment Therapy

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).

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Coitus Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for AIDS Prevention Studies

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DuoPACT

Behavioral

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

LifeSteps

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

A Couples-based Approach to Improving Engagement in HIV Care

Acronym: DuoPACT

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2016
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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