- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362476
Computer-based Intervention for Alcohol-using HIV/HCV+ Women
October 31, 2022 updated by: New York University
Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
The study harnessed the multidisciplinary expertise of our research team to develop a brief, computer-based, alcohol reduction intervention tailored 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.
Study Overview
Status
Completed
Conditions
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 study harnessed the multidisciplinary expertise and experience of collaborative Russian-U.S. research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy.
The study was 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 PLUS PLUS provider-delivered brief motivational counseling, or (2) provider-delivered brief motivational counseling.
The trial design and analysis provide an appropriate conceptual and methodological framework to assess the efficacy of the 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
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint Petersburg, Russian Federation, 197376
- North West District AIDS Center
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-
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New York
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New York, New York, United States, 10003
- New York University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 EtG analysis OR self-reported alcohol use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling
Brief, computer-based, alcohol reduction intervention based on motivational enhancement therapy (MET) tailored for HIV/HCV co-infected women who used alcohol. Clinician-based MET counseling plus standard-of-care (SOC) for current substance users. |
Brief computer-based version of motivation enhancement therapy (MET) used in conjunction with clinician-delivered MET and 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 intervention was adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV.
Clinician-delivered MET used in conjunction with standard clinical care for current substance users.
The brief intervention is focused on goals, cravings, problem-solving and decision-making.
The intervention was adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV.
Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.
|
Active Comparator: Clinican-delivered brief MET counseling
Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users.
only
|
Clinician-delivered MET used in conjunction with standard clinical care for current substance users.
The brief intervention is focused on goals, cravings, problem-solving and decision-making.
The intervention was adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV.
Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of women who test ethyl glucuronide (EtG) negative
Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
|
Proportion of women who test ethyl glucuronide (EtG) negative will be estimated to evaluate the efficacy of the adapted computer-based alcohol reduction intervention condition, relative to standard of care condition.
|
Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of women who test Phosphatidylethanol (PEth) negative (<= 8 ng/mL)
Time Frame: Baseline assessment and follow-up assessments at 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.
|
Baseline assessment and follow-up assessments at 9-month post-baseline
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Change in HIV viral load (VL)
Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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HIV viral load (VL) will be measured by testing blood to evaluate HIV disease progression.
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Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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Change in CD4 cell count
Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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CD4 count will be measured by testing blood to evaluate HIV disease progression.
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Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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Change in FibroTest score
Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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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.
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Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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Change in liver stiffness
Time Frame: Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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FibroScan - imaging modality - will be used to measure changes in liver stiffness.
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Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ralph J Diclemente, PhD, New York University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2018
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
November 30, 2017
First Submitted That Met QC Criteria
December 4, 2017
First Posted (Actual)
December 5, 2017
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Slow Virus Diseases
- Alcoholism
- HIV Infections
- Hepatitis
- Hepatitis C
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- IRB00094637
- R01AA025882-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified (IPD) collected in this study will be made available to other researchers.
IPD Sharing Time Frame
Will be shared upon request by investigators
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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