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

Hepatitis C Clinical Trial

Official title:

Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362476
• Other study ID #: IRB00094637
• Secondary ID: R01AA025882-01
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2022
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol Abuse
• Alcoholism
• Hepatitis
• Hepatitis C
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• Computer-based alcohol reduction intervention
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.
• Brief clinician-delivered MET
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.
• Standard of care
Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.

Locations

Country	Name	City	State
Russian Federation	North West District AIDS Center	Saint Petersburg
United States	New York University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Countries where clinical trial is conducted

United States,  Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
Secondary	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.	Baseline assessment and follow-up assessments at 9-month post-baseline
Secondary	Change in HIV viral load (VL)	HIV viral load (VL) will be measured by testing blood to evaluate HIV disease progression.	Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
Secondary	Change in CD4 cell count	CD4 count will be measured by testing blood to evaluate HIV disease progression.	Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
Secondary	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 a2-macroglobulin, haptoglobin, ?-glutamyl transpeptidatse, apolipoprotein A1, alanine transaminase, and total bilirubin.	Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline
Secondary	Change in liver stiffness	FibroScan - imaging modality - will be used to measure changes in liver stiffness.	Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline