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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Immunodeficiency Virus, Hepatitis C, Alcohol Abuse

Intervention / Treatment
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* Behavioral: Computer-based alcohol reduction intervention
* Behavioral: Brief clinician-delivered MET
* Behavioral: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention 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<br>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. | Behavioral: Computer-based alcohol reduction intervention<br>* 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.<br>Behavioral: Brief clinician-delivered MET<br>* 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.<br>Behavioral: Standard of care<br>* Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.<br>|
| Active Comparator: Clinican-delivered brief MET counseling<br>Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only | Behavioral: Brief clinician-delivered MET<br>* 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.<br>Behavioral: Standard of care<br>* Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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. | Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunodeficiency Virus, Hepatitis C, Computer Intervention, Alcoholism, Women, Russia