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

New York University (NYU)

Status: Completed

Conditions: Human Immunodeficiency Virus; Hepatitis C; Alcohol Abuse

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03362476

R01AA025882-01 (U.S. NIH Grant/Contract)

IRB00094637

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No 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 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

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

Experimental group

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.

Treatment:

Behavioral: Computer-based alcohol reduction intervention

Behavioral: Standard of care

Behavioral: Brief clinician-delivered MET

Clinician-delivered brief MET counseling

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard of care

Behavioral: Brief clinician-delivered MET