HIV Prevention Intervention for People Living With HIV/AIDS

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01061021
First received: February 1, 2010
Last updated: November 15, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: In The Mix
Behavioral: Information Support Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV Treatment Adherence/Risk Reduction Integrated

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Computerized Interview or Sexual Transmission Risk Behavior [ Time Frame: Baseline, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • Unannounced Phone Based Pill Counts for Medication Adherence [ Time Frame: Baseline, 3, 6, 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infectiousness Beliefs [ Time Frame: Baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]

Enrollment: 490
Study Start Date: March 2005
Study Completion Date: August 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated Intervention
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.
Behavioral: In The Mix
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.
Active Comparator: Comparison Group
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.
Behavioral: Information Support Group
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant cognitive impairment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061021

Locations
United States, Georgia
Southeast HIV/AIDS Research and Evaluation Project
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Seth C Kalichman, PhD University of Connecticut
  More Information

No publications provided

Responsible Party: Seth C. Kalichman / Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT01061021     History of Changes
Other Study ID Numbers: H06-113, R01MH071164-04
Study First Received: February 1, 2010
Last Updated: November 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut:
HIV prevention
Treatment adherence
Treatment for Prevention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 23, 2014