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Trial record 3 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Hepatitis C Alcohol Abuse Behavioral: Computer-based alcohol reduction intervention Behavioral: Standard-of-care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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.

Standard-of-care.
Routine counseling to avoid alcohol and drugs.
Behavioral: Standard-of-care
Routine counseling to avoid alcohol and drugs.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362476


Contacts
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Contact: Ralph J Diclemente, PhD 212-992-3709 rjd438@nyu.edu
Contact: Ariadna Capasso, MFA 212-992-3709 ac7113@nyu.edu

Locations
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United States, New York
New York University Not yet recruiting
New York, New York, United States, 10003
Contact: Ralph J DiClemente, PhD    212-992-3709    rjd438@nyu.edu   
Russian Federation
North West District AIDS Center Recruiting
Saint Petersburg, Russian Federation, 197376
Contact: Nicolay Belyakov, MD    +7 (812) 233-34-83    polinasafonova@mail.ru   
Contact: Alina Bobreshova, MD    +7 (812) 233-73-36      
Sponsors and Collaborators
New York University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Ralph J Diclemente, PhD New York University

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Responsible Party: Ralph DiClemente, Professor, New York University
ClinicalTrials.gov Identifier: NCT03362476     History of Changes
Other Study ID Numbers: IRB00094637
R01AA025882-01 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ralph DiClemente, New York University:
Human Immunodeficiency Virus
Hepatitis C
Computer Intervention
Alcoholism
Women
Russia
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Slow Virus Diseases
Ethanol
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Immunologic Deficiency Syndromes
Alcoholism
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs