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Computer-based Intervention for Alcohol-using HIV/HCV+ Women

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ClinicalTrials.gov Identifier: NCT03362476
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University

November 30, 2017
December 5, 2017
January 11, 2018
January 3, 2018
February 29, 2020   (Final data collection date for primary outcome measure)
Proportion of women who test PEth negative (<= 8 ng/mL) [ Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline ]
Proportion of women who test PEth negative (<= 8 ng/mL) will be estimated to evaluate the efficacy of the adapted computer-based alcohol reduction intervention condition, relative to standard of care condition.
Same as current
Complete list of historical versions of study NCT03362476 on ClinicalTrials.gov Archive Site
  • Change in HIV viral load (VL) [ Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline ]
    HIV viral load (VL) will be measured by testing blood to evaluate HIV disease progression.
  • Change in CD4 count [ Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline ]
    CD4 count will be measured by testing blood to evaluate HIV disease progression.
  • Change in FibroTest score [ Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline ]
    FibroTest, is a biomarker test that uses the results of six blood serum tests to generate a score that is correlated with the degree of liver damage. It combines α2-macroglobulin, haptoglobin, γ-glutamyl transpeptidatse, apolipoprotein A1, alanine transaminase, and total bilirubin.
  • Change in liver stiffness [ Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline ]
    FibroScan - imaging modality - will be used to measure changes in liver stiffness.
Same as current
Not Provided
Not Provided
 
Computer-based Intervention for Alcohol-using HIV/HCV+ Women
Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
The study will harness the multidisciplinary expertise to adapt an effective alcohol reduction computer-based intervention, called CBT4CBT, to enhance its appropriateness for HIV/HCV co-infected women and evaluate its efficacy. The intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy, that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women's health and reduce HIV/HCV transmission risk.
Women co-infected with HIV and HCV are at elevated risk for adverse health outcomes associated with alcohol use. Evidence-based alcohol reduction interventions for this vulnerable population are limited. To address this gap, the proposed study will harness the multidisciplinary expertise and experience of collaborative Russian-U.S. research team to adapt an effective computer-based intervention, called CBT4CBT, to enhance its appropriateness for HIV/HCV co-infected women and evaluate its efficacy. The proposed study will be conducted in three sequential stages: (1) Adaptation, (2) Implementation, and (3) Evaluation. Participants will be randomized to one of two conditions: (1) adapted computer-based alcohol reduction intervention, or (2) standard-of-care control condition. The proposed trial design and analysis provide an appropriate conceptual and methodological framework to assess the efficacy of the adapted computer-based intervention. The intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women's health and reduce HIV/HCV transmission risk.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Human Immunodeficiency Virus
  • Hepatitis C
  • Alcohol Abuse
  • Behavioral: Computer-based alcohol reduction intervention
    CBT4CBT is a computer-based version of cognitive behavioral therapy (CBT) used in conjunction with standard clinical care for current substance users. Modules and follow up assignments focus on key concepts in substance use, including cravings, problem solving and decision making skills. The multimedia presentation, based on elementary level computer learning games, requires no previous experience with computers.The CBT4CBT intervention will be adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV.
  • Behavioral: Standard-of-care
    Routine counseling to avoid alcohol and drugs.
  • Experimental: Computer-based alcohol reduction intervention.
    CBT4CBT is a computer-based version of cognitive behavioral therapy (CBT) used in conjunction with standard clinical care for current substance users.
    Interventions:
    • Behavioral: Computer-based alcohol reduction intervention
    • Behavioral: Standard-of-care
  • Standard-of-care.
    Routine counseling to avoid alcohol and drugs.
    Intervention: Behavioral: Standard-of-care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
Same as current
February 29, 2020
February 29, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • female;
  • receiving HIV medical care at the AIDS Center;
  • chart-documented HIV and chronic HCV infection;
  • currently prescribed an ARV regimen;
  • medically, cognitively, and psychologically capable of study participation;
  • laboratory-confirmed recent alcohol use as detected by a PEth analysis.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years to 40 Years   (Adult)
No
Contact: Ralph J Diclemente, PhD 404-727-0237 rdiclem@emory.edu
Contact: Tiffaney Renfro, MSW 404-712-8890 twilli7@emory.edu
Russian Federation,   United States
 
 
NCT03362476
IRB00094637
R01AA025882-01 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Ralph J. DiClemente, Emory University
Emory University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Ralph J Diclemente, PhD Emory University
Emory University
January 2018

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