DuoPACT Pilot Intervention

NCT ID: NCT02181881

Last Updated: 2024-02-15

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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

Intervention sessions are administered weekly by a counselor.

Life Steps

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

Group Type ACTIVE_COMPARATOR

Life Steps

Intervention Type BEHAVIORAL

Intervention sessions are administered weekly by a counselor.

Treatment as usual (TAU)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DuoPACT

Intervention sessions are administered weekly by a counselor.

Intervention Type BEHAVIORAL

Life Steps

Intervention sessions are administered weekly by a counselor.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

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

Other Identifiers

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R01NR010187

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01NR010187

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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