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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 : March 1, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Ralph DiClemente, New York University

Tracking Information
First Submitted Date  ICMJE November 30, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE January 3, 2018
Estimated Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
Proportion of women who test Phosphatidylethanol (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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
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.
Change History Complete list of historical versions of study NCT03362476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • 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 cell 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computer-based Intervention for Alcohol-using HIV/HCV+ Women
Official Title  ICMJE Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
Brief Summary 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.
Detailed Description Women co-infected with human immunodeficiency viruses (HIV) and Hepatitis C (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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Human Immunodeficiency Virus
  • Hepatitis C
  • Alcohol Abuse
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2017)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 29, 2020
Estimated Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female;
  • receiving HIV medical care at the AIDS Center;
  • chart-documented HIV and chronic HCV infection;
  • currently prescribed an antiretroviral (ARV) regimen;
  • medically, cognitively, and psychologically capable of study participation;
  • laboratory-confirmed recent alcohol use as detected by a PEth analysis.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ralph J Diclemente, PhD 212-992-3709 rjd438@nyu.edu
Contact: Ariadna Capasso, MFA 212-992-3709 ac7113@nyu.edu
Listed Location Countries  ICMJE Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03362476
Other Study ID Numbers  ICMJE IRB00094637
R01AA025882-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ralph DiClemente, New York University
Study Sponsor  ICMJE New York University
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Ralph J Diclemente, PhD New York University
PRS Account New York University
Verification Date February 2019

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