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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:
Information provided by (Responsible Party):

Study Description
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
Human Immunodeficiency Virus Hepatitis C Alcohol Abuse Behavioral: Computer-based alcohol reduction intervention Behavioral: Standard-of-care

Detailed Description:
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.

Study Design

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
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


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 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.


Eligibility Criteria

Information from the National Library of Medicine

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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 ARV regimen;
  • medically, cognitively, and psychologically capable of study participation;
  • laboratory-confirmed recent alcohol use as detected by a PEth analysis.
Contacts and Locations

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
Contact: Ralph J Diclemente, PhD 404-727-0237 rdiclem@emory.edu
Contact: Tiffaney Renfro, MSW 404-712-8890 twilli7@emory.edu

Locations
United States, Georgia
Rollins School of Public Health Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Ralph J Diclemente    404-727-0237    rdiclem@emory.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
Emory University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Ralph J Diclemente, PhD Emory University
More Information

Responsible Party: Ralph J. DiClemente, Professor, Emory 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: January 11, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ralph J. DiClemente, Emory University:
HIV
HCV
Computer Intervention
Alcoholism
Women
Russia

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis C
Immunologic Deficiency Syndromes
Alcoholism
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs