Behavioral Intervention to Enhance HIV Test/Treat

This study is currently recruiting participants.
Verified June 2013 by University of Connecticut
Sponsor:
Information provided by (Responsible Party):
Seth Kalichman, University of Connecticut
ClinicalTrials.gov Identifier:
NCT01752777
First received: December 16, 2012
Last updated: June 14, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • HIV RNA Viral Load [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    HIV RNA viral load determined by blood plasma PCR


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Age 18 and older
  • HIV positive
  • Sexually active in the previous Month
  • Active substance use

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752777

Contacts
Contact: Seth Kalichman, PhD 860-208-3706 seth.k@uconn.edu
Contact: Chauncey Cherry, MPH 860-486-8702 chaunceycherry@share.uconn.edu

Locations
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         
Sponsors and Collaborators
University of Connecticut
  More Information

No publications provided

Responsible Party: Seth Kalichman, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT01752777     History of Changes
Other Study ID Numbers: H11-159
Study First Received: December 16, 2012
Last Updated: June 14, 2013
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 April 16, 2014