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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

February 1, 2010
November 15, 2010
March 2005
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01061021 on ClinicalTrials.gov Archive Site
Infectiousness Beliefs [ Time Frame: Baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HIV Prevention Intervention for People Living With HIV/AIDS
HIV Treatment Adherence/Risk Reduction Integrated

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: In The Mix
  • 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.
    Intervention: Behavioral: Information Support Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
490
August 2010
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant cognitive impairment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01061021
H06-113, R01MH071164-04
No
Seth C. Kalichman / Professor, University of Connecticut
University of Connecticut
National Institute of Mental Health (NIMH)
Principal Investigator: Seth C Kalichman, PhD University of Connecticut
University of Connecticut
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP