Behavioral Intervention to Enhance HIV Test/Treat
1 other identifier
interventional
500
1 country
1
Brief Summary
Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study will test a theory-based behavioral intervention to reduce HIV infectiousness by simultaneously improving HIV treatment adherence and reducing sexually transmitted co-infections in people living with HIV-AIDS who use alcohol and other drugs. The intervention is delivered in a single office-based counseling session followed by 4 cell phone delivered counseling sessions in a model that will be ready for immediate dissemination to case management and clinical services for people living with HIV/AIDS in resource constrained settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
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
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 16, 2012
CompletedFirst Posted
Study publicly available on registry
December 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMay 9, 2018
May 1, 2018
6 years
December 16, 2012
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV RNA Viral Load
HIV RNA viral load determined by blood plasma PCR
12 month
Secondary Outcomes (1)
Sexual Transmission Risk Behaviors
3 month
Study Arms (2)
Infectiousness Risk Reduction
EXPERIMENTALBehavioral counseling conducted in one office session followed by 4 cell-phone-based sessions. Counseling is based on models of behavioral self-management and cognitive decision making with the primary aim to increase antiretroviral adherence, engagement in HIV care, and reduction of sexual risk behaviors for HIV transmission.
General Health Improvement
SHAM COMPARATORParticipants in this condition receive education conducted in one office session followed by 4 cell-phone-based sessions. The education sessions focus on raising awareness of health services and health improvement strategies.
Interventions
Behavioral counseling conducted in one office session followed by 4 cell-phone-based sessions. Counseling is based on models of behavioral self-management and cognitive decision making with the primary aim to increase antiretroviral adherence, engagement in HIV care, and reduction of sexual risk behaviors for HIV transmission.
Educational counseling to help link participants to social serves and health related strategies.
Eligibility Criteria
You may qualify if:
- Age 18 and older
- HIV positive
- Sexually active in the previous Month
- Active substance use
You may not qualify if:
- None
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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 16, 2012
First Posted
December 19, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
May 9, 2018
Record last verified: 2018-05