HIV Prevention Intervention for People Living With HIV/AIDS
HIV Treatment Adherence/Risk Reduction Integrated
2 other identifiers
interventional
490
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Mar 2005
Longer than P75 for phase_2 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedNovember 17, 2010
November 1, 2010
4.6 years
February 1, 2010
November 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Computerized Interview or Sexual Transmission Risk Behavior
Baseline, 3, 6 and 9 months
Unannounced Phone Based Pill Counts for Medication Adherence
Baseline, 3, 6, 9 months
Secondary Outcomes (1)
Infectiousness Beliefs
Baseline, 3, 6, and 9 months
Study Arms (2)
Integrated Intervention
EXPERIMENTALFive 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.
Comparison Group
ACTIVE COMPARATORFive small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 18 years or older,
- Tested HIV positive,
- Able to provide informed consent.
You may not qualify if:
- Significant cognitive impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southeast HIV/AIDS Research and Evaluation Project
Atlanta, Georgia, 30308, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seth C Kalichman, PhD
University of Connecticut
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 2, 2010
Study Start
March 1, 2005
Primary Completion
October 1, 2009
Study Completion
August 1, 2010
Last Updated
November 17, 2010
Record last verified: 2010-11