search
Back to results

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

Primary Purpose

Human Immunodeficiency Virus, Hepatitis C, Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Computer-based alcohol reduction intervention
Brief clinician-delivered MET
Standard of care
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, Hepatitis C, Computer Intervention, Alcoholism, Women, Russia

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • New York University
  • North West District AIDS Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling

Clinican-delivered brief MET counseling

Arm Description

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.

Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only

Outcomes

Primary Outcome Measures

Proportion of women who test ethyl glucuronide (EtG) negative
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.

Secondary Outcome Measures

Proportion of women who test Phosphatidylethanol (PEth) negative (<= 8 ng/mL)
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 in HIV viral load (VL)
HIV viral load (VL) will be measured by testing blood to evaluate HIV disease progression.
Change in CD4 cell count
CD4 count will be measured by testing blood to evaluate HIV disease progression.
Change in FibroTest score
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
FibroScan - imaging modality - will be used to measure changes in liver stiffness.

Full Information

First Posted
November 30, 2017
Last Updated
October 31, 2022
Sponsor
New York University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03362476
Brief Title
Computer-based Intervention for Alcohol-using HIV/HCV+ Women
Official Title
Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Hepatitis C, Alcohol Abuse
Keywords
Human Immunodeficiency Virus, Hepatitis C, Computer Intervention, Alcoholism, Women, Russia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinican-delivered brief MET counseling
Arm Type
Active Comparator
Arm Description
Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only
Intervention Type
Behavioral
Intervention Name(s)
Computer-based alcohol reduction intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief clinician-delivered MET
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.
Primary Outcome Measure Information:
Title
Proportion of women who test ethyl glucuronide (EtG) negative
Description
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.
Time Frame
Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
Secondary Outcome Measure Information:
Title
Proportion of women who test Phosphatidylethanol (PEth) negative (<= 8 ng/mL)
Description
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.
Time Frame
Baseline assessment and follow-up assessments at 9-month post-baseline
Title
Change in HIV viral load (VL)
Description
HIV viral load (VL) will be measured by testing blood to evaluate HIV disease progression.
Time Frame
Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
Title
Change in CD4 cell count
Description
CD4 count will be measured by testing blood to evaluate HIV disease progression.
Time Frame
Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
Title
Change in FibroTest score
Description
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.
Time Frame
Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
Title
Change in liver stiffness
Description
FibroScan - imaging modality - will be used to measure changes in liver stiffness.
Time Frame
Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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 EtG analysis OR self-reported alcohol use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph J Diclemente, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
North West District AIDS Center
City
Saint Petersburg
ZIP/Postal Code
197376
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
33596972
Citation
DiClemente RJ, Brown JL, Capasso A, Revzina N, Sales JM, Boeva E, Gutova LV, Khalezova NB, Belyakov N, Rassokhin V. Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial. Trials. 2021 Feb 17;22(1):147. doi: 10.1186/s13063-021-05079-x.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs