DuoPACT Pilot Intervention

Relationship Factors and HIV Treatment Adherence

The investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment as usual (TAU) assessment-only control condition. 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 acceptability and feasibility.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: DuoPACT; Behavioral: Life Steps

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94105
      • Center for AIDS Prevention Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Gay male couple.
2. One or both partners must be HIV positive and on antiretroviral medications.

Exclusion Criteria:

Must be able to consent to and follow study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DuoPACT; A 6-session HIV medication adherence support program for couples.	Behavioral: DuoPACT; Intervention sessions are administered weekly by a counselor.
Active Comparator: Life Steps; A 3-session HIV medication adherence support program for individuals.	Behavioral: Life Steps; Intervention sessions are administered weekly by a counselor.
No Intervention: Treatment as usual (TAU); HIV positive individuals will continue to follow their current HIV treatment plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the intervention	All participants are assessed post intervention to evaluate intervention satisfaction and acceptability.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	All participants are assessed post intervention to evaluate the study's feasibility.	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Mallory O Johnson, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimated): July 4, 2014

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01NR010187 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No