Behavioral Intervention to Enhance HIV Test/Treat

This study is currently recruiting participants. (see Contacts and Locations)
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

December 16, 2012
June 14, 2013
February 2012
February 2016   (final data collection date for primary outcome measure)
HIV RNA Viral Load [ Time Frame: 12 month ] [ Designated as safety issue: No ]
HIV RNA viral load determined by blood plasma PCR
Same as current
Complete list of historical versions of study NCT01752777 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Behavioral Intervention to Enhance HIV Test/Treat
Behavioral Intervention to Enhance HIV Test/Treat

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
HIV/AIDS
  • 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.
  • Behavioral: General Health Improvement
    Educational counseling to help link participants to social serves and health related strategies.
  • 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.
    Intervention: Behavioral: Infectiousness Risk Reduction
  • 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.
    Intervention: Behavioral: General Health Improvement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
February 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact: Seth Kalichman, PhD 860-208-3706 seth.k@uconn.edu
Contact: Chauncey Cherry, MPH 860-486-8702 chaunceycherry@share.uconn.edu
United States
 
NCT01752777
H11-159
Yes
Seth Kalichman, University of Connecticut
University of Connecticut
Not Provided
Not Provided
University of Connecticut
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP