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HIV Prevention Intervention for People Living With HIV/AIDS

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ClinicalTrials.gov Identifier: NCT01061021
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : November 17, 2010
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: In The Mix Behavioral: Information Support Group Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV Treatment Adherence/Risk Reduction Integrated
Study Start Date : March 2005
Primary Completion Date : October 2009
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Computerized Interview or Sexual Transmission Risk Behavior [ Time Frame: Baseline, 3, 6 and 9 months ]
  2. Unannounced Phone Based Pill Counts for Medication Adherence [ Time Frame: Baseline, 3, 6, 9 months ]

Secondary Outcome Measures :
  1. Infectiousness Beliefs [ Time Frame: Baseline, 3, 6, and 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061021


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

Responsible Party: Seth C. Kalichman / Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT01061021     History of Changes
Other Study ID Numbers: H06-113
R01MH071164-04 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: November 17, 2010
Last Verified: November 2010

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

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