- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01752777
Behavioral Intervention to Enhance HIV Test/Treat
May 8, 2018 updated by: Seth Kalichman, University of Connecticut
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Scalable interventions are urgently needed to sustain low infectiousness by improving HIV treatment adherence and reducing risks for 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 who use alcohol and other drugs.
Grounded in Conflict Theory of Decision Making, the intervention will be delivered in a mixed format, with one office-based counseling session followed by four cell phone delivered counseling sessions.
The intervention will be conducted in Atlanta and surrounding impoverished areas.
Men (n = 250) and women (n = 250) receiving HIV treatment will be recruited from AIDS services and infectious disease clinics.
Following informed consent and baseline assessments, participants will be randomly assigned to either an (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched non-contaminating attention control condition.
Participants will be followed for 12-months using office-based computerized interviews, unannounced pill counts, and medical chart abstraction.
The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will reduce HIV transmission risk behaviors, improve HIV treatment adherence, reduce viral load and prevent new STI.
The study will also examine the influence of theoretical constructs and structural barriers on intervention outcomes.
Factors that predict relapse to non-adherence and risk behaviors in relation to changes in viral load and STI over the 12-month follow-up period will also be a focal point of the study.
The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model for substance using HIV positive men and women.
If shown effective, the intervention model will be ready for immediate dissemination to community and clinical services for people living with HIV/AIDS.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30308
- Southeast HIV/AIDS Research and Evaluation Project
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 and older
- HIV positive
- Sexually active in the previous Month
- Active substance use
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Infectiousness Risk Reduction
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.
|
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.
|
SHAM_COMPARATOR: General Health Improvement
Participants 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.
|
Educational counseling to help link participants to social serves and health related strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV RNA Viral Load
Time Frame: 12 month
|
HIV RNA viral load determined by blood plasma PCR
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Transmission Risk Behaviors
Time Frame: 3 month
|
Sexual behaviors that create risks for HIV transmission and protective actions against transmission risks
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2012
Primary Completion (ACTUAL)
February 1, 2018
Study Completion (ACTUAL)
February 1, 2018
Study Registration Dates
First Submitted
December 16, 2012
First Submitted That Met QC Criteria
December 18, 2012
First Posted (ESTIMATE)
December 19, 2012
Study Record Updates
Last Update Posted (ACTUAL)
May 9, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- H11-159
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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