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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
200
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.
New York University
New York, New York, United States
North West District AIDS Center
Saint Petersburg, Russia
Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative
Percentage 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. Ethyl glucuronide will be measured in urine, with a sample taken at point-of-care at baseline and follow-ups. The definition of EtG negative is \<500ng/mL. A dichotomous score will be created for times 3, 6, and 9-months post baseline, with participants testing EtG negative over the three time points assigned a 0 and participants testing EtG positive at any of the three follow-up points assigned a 1.
Time frame: 3-, 6-, and 9-month post-baseline
Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL)
Percentage 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: 9-month post-baseline
Percentage of Participants in the Intervention Group With an Undetectable HIV Viral Load Compared to the Percentage of Women in the Control Group With an Undetectable Viral Load
HIV viral load (VL) will be measured by testing blood to evaluate HIV disease progression. The measure is the number of participants with an undetectable viral load (\<200 HIV copies per milliliter of blood.). A dichotomous measure is created by which any participant who has an undetectable viral load at 9-month post-baseline is assigned a 0 and any participant with a detectable viral load at that time point is assigned a 1.
Time frame: 9-month post-baseline
CD4 Cell Count
CD4 count will be measured at 9-months post-baseline and compared between intervention groups. CD4 is measured as the number of CD4 cells per cubic mm of blood.
Time frame: 9-month post-baseline
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Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.
Count of Women With a Severe FibroTest Score (3-4) at 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 transpeptidase, apolipoprotein A1, alanine transaminase, and total bilirubin. FibroTest is scored on a scale of 0-4 depending on severity: 0-1 being mild liver damage; 1-2 being moderate; and 3-4 being severe damage. This outcome presents the count of women with a severe FibroTest score (3-4) at 9-months post baseline.
Time frame: 9-month post-baseline
Liver Stiffness
FibroScan - imaging modality - will be used to measure liver stiffness at 9-months post-baseline and compared by intervention group. Liver stiffness is diagnosed by a medical specialist.
Time frame: 9-month post-baseline