DuoPACT Pilot Intervention

NCT02181881 | Completed DMC

• 1 other identifier: R01NR010187
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Satisfaction with the intervention

  All participants are assessed post intervention to evaluate intervention satisfaction and acceptability.

  3 months

Secondary Outcomes (1)

• Feasibility

  3 months

Study Arms (3)

DuoPACT

ACTIVE COMPARATOR

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

Behavioral: DuoPACT

Life Steps

ACTIVE COMPARATOR

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

Behavioral: Life Steps

Treatment as usual (TAU)

NO INTERVENTION

HIV positive individuals will continue to follow their current HIV treatment plan.

Interventions

DuoPACT BEHAVIORAL

Intervention sessions are administered weekly by a counselor.

DuoPACT

Life Steps BEHAVIORAL

Intervention sessions are administered weekly by a counselor.

Life Steps

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Must be able to consent to and follow study protocol.

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, 94105, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Study Officials

• Mallory O Johnson, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)