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HIV Prevention Intervention for People Living With HIV/AIDS

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
In The Mix
Information Support Group
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV prevention, Treatment adherence, Treatment for Prevention

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or older,
  • Tested HIV positive,
  • Able to provide informed consent.

Exclusion Criteria:

  • Significant cognitive impairment.

Sites / Locations

  • Southeast HIV/AIDS Research and Evaluation Project

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Intervention

Comparison Group

Arm Description

Five small group + 2 individual counseling behavioral intervention to simultaneously address HIV transmission risk reduction and HIV treatment adherence in men and women living with HIV/AIDS.

Five small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement.

Outcomes

Primary Outcome Measures

Computerized Interview or Sexual Transmission Risk Behavior
Unannounced Phone Based Pill Counts for Medication Adherence

Secondary Outcome Measures

Infectiousness Beliefs

Full Information

First Posted
February 1, 2010
Last Updated
November 15, 2010
Sponsor
University of Connecticut
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01061021
Brief Title
HIV Prevention Intervention for People Living With HIV/AIDS
Official Title
HIV Treatment Adherence/Risk Reduction Integrated
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Connecticut
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
HIV prevention interventions are needed to assist people living with HIV/AIDS to adhere to their medications and not transmit the virus to others. This study is testing a behavioral intervention designed to address both medication adherence and risk reduction in people living with HIV/AIDS. It is hypothesized that the experimental behavioral intervention will show improved medication adherence and safer sexual behaviors compared to a comparison group.
Detailed Description
Non-adherence to antiretroviral medications can lead to the development of treatment resistant genetic variants of HIV which can then be transmitted to sexual risk partners. Interventions are urgently needed to reduce the risk of HIV treatment resistance and the risks of transmitting HIV. This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk behaviors in people living with HIV-AIDS. Grounded in behavioral theory, the experimental intervention will be delivered in a mixed format model with five group sessions preceded by and followed by one individual counseling session conducted by community-based group facilitators. The intervention will be conducted at an AIDS service organization in Atlanta. Men and women will be recruited from a variety of AIDS services and infectious disease clinics. Following informed consent and baseline assessments participants will be randomly assigned to receive either the (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched sexual risk reduction intervention, or (c) a time matched non-contaminating comparison intervention. Participants will be followed over the course of a 9-month observation period. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence and HIV transmission risks and risk reduction, medication adherence, sexual transmission risk behaviors, viral load, and CD4 cell counts. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will improve HIV treatment adherence, reduce HIV transmission risk behaviors, and improve health as indexed by viral load and CD4 cell counts. The study will also examine the influence of theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model derived from a single, unified theory of health behavior. If shown effective, the intervention model will be ready for immediate dissemination to community services for people living with HIV-AIDS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV prevention, Treatment adherence, Treatment for Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Intervention
Arm Type
Experimental
Arm Description
Five small group + 2 individual counseling behavioral intervention to simultaneously address HIV transmission risk reduction and HIV treatment adherence in men and women living with HIV/AIDS.
Arm Title
Comparison Group
Arm Type
Active Comparator
Arm Description
Five small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement.
Intervention Type
Behavioral
Intervention Name(s)
In The Mix
Intervention Description
Five small group + 2 individual counseling intervention designed to addresses HIV transmission risk behavior and HIV treatment adherence in men and women living with HIV/AIDS.
Intervention Type
Behavioral
Intervention Name(s)
Information Support Group
Intervention Description
Five small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement.
Primary Outcome Measure Information:
Title
Computerized Interview or Sexual Transmission Risk Behavior
Time Frame
Baseline, 3, 6 and 9 months
Title
Unannounced Phone Based Pill Counts for Medication Adherence
Time Frame
Baseline, 3, 6, 9 months
Secondary Outcome Measure Information:
Title
Infectiousness Beliefs
Time Frame
Baseline, 3, 6, and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older, Tested HIV positive, Able to provide informed consent. Exclusion Criteria: Significant cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth C Kalichman, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast HIV/AIDS Research and Evaluation Project
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

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HIV Prevention Intervention for People Living With HIV/AIDS

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