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

Not Applicable

Completed

Conditions: Alcohol Abuse
Hepatitis C
Human Immunodeficiency Virus

Interventions: Behavioral: Computer-based alcohol reduction intervention
Behavioral: Brief clinician-delivered MET
Behavioral: Standard of care

Registration Number: NCT03362476

Lead Sponsor: New York University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 200

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 Ethylglucuronide (EtG) analysis or self-reported alcohol use

Exclusion Criteria

not identifying as biological female
not HIV and HCV positive
no laboratory-confirmed or self-reported
not willing to participate in the trial
not able to participate in the trial due to medical, cognitive, or psychological issues

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling	Computer-based alcohol reduction intervention	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.
Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling	Brief clinician-delivered MET	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.
Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling	Standard of care	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.
Clinican-delivered brief MET counseling	Brief clinician-delivered MET	Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only
Clinican-delivered brief MET counseling	Standard of care	Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only

Primary Outcome Measures

Name	Time	Method
Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative	3-, 6-, and 9-month post-baseline	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL)	9-month post-baseline	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.
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	9-month post-baseline	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.
CD4 Cell Count	9-month post-baseline	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.
Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline	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.
Liver Stiffness	9-month post-baseline	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.