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DuoPACT Pilot Intervention

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DuoPACT
Life Steps
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for AIDS Prevention Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

DuoPACT

Life Steps

Treatment as usual (TAU)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Feasibility
All participants are assessed post intervention to evaluate the study's feasibility.

Full Information

First Posted
July 2, 2014
Last Updated
October 21, 2014
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02181881
Brief Title
DuoPACT Pilot Intervention
Official Title
Relationship Factors and HIV Treatment Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DuoPACT
Arm Type
Active Comparator
Arm Description
A 6-session HIV medication adherence support program for couples.
Arm Title
Life Steps
Arm Type
Active Comparator
Arm Description
A 3-session HIV medication adherence support program for individuals.
Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
HIV positive individuals will continue to follow their current HIV treatment plan.
Intervention Type
Behavioral
Intervention Name(s)
DuoPACT
Intervention Description
Intervention sessions are administered weekly by a counselor.
Intervention Type
Behavioral
Intervention Name(s)
Life Steps
Intervention Description
Intervention sessions are administered weekly by a counselor.
Primary Outcome Measure Information:
Title
Satisfaction with the intervention
Description
All participants are assessed post intervention to evaluate intervention satisfaction and acceptability.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Feasibility
Description
All participants are assessed post intervention to evaluate the study's feasibility.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gay male couple. One or both partners must be HIV positive and on antiretroviral medications. Exclusion Criteria: Must be able to consent to and follow study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mallory O Johnson, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for AIDS Prevention Studies
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States

12. IPD Sharing Statement

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DuoPACT Pilot Intervention

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