Behavioral Intervention to Enhance HIV Test/Treat
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV/AIDS |
Behavioral: Infectiousness Risk Reduction Behavioral: General Health Improvement |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Behavioral Intervention to Enhance HIV Test/Treat |
- HIV RNA Viral Load [ Time Frame: 12 month ] [ Designated as safety issue: No ]HIV RNA viral load determined by blood plasma PCR
- Sexual Transmission Risk Behaviors [ Time Frame: 3 month ] [ Designated as safety issue: No ]Sexual behaviors that create risks for HIV transmission and protective actions against transmission risks
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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: 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.
|
|
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.
|
Behavioral: General Health Improvement
Educational counseling to help link participants to social serves and health related strategies.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 and older
- HIV positive
- Sexually active in the previous Month
- Active substance use
Exclusion Criteria:
- None
Contacts and Locations| Contact: Seth Kalichman, PhD | 860-208-3706 | seth.k@uconn.edu |
| Contact: Chauncey Cherry, MPH | 860-486-8702 | chaunceycherry@share.uconn.edu |
| United States, Georgia | |
| Southeast HIV/AIDS Research and Evaluation Project | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact: Chauncey Cherry, PhD 860-486-8702 chaunceycherry@share.uconn.edu | |
| Principal Investigator: Seth Kalichman, PhD | |
More Information
No publications provided
| Responsible Party: | Seth Kalichman, Professor, University of Connecticut |
| ClinicalTrials.gov Identifier: | NCT01752777 History of Changes |
| Other Study ID Numbers: | 1R01DA033067-01 |
| Study First Received: | December 16, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: National Institutes of Health |
Keywords provided by University of Connecticut:
|
HIV/AIDS, HIV infectiousness, Medication adherence, Sexual risks reduction |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013