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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons

NCT02316184

HIV Hepatitis C

COMPLETED NA

Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum

NCT04090723

HIV Alcohol; Harmful Use Mental Health Disorder

ACTIVE_NOT_RECRUITING NA

Internet-based Videoconferencing to Address Alcohol Use and Pain

NCT03982433

Chronic Pain Alcohol Use, Unspecified

COMPLETED NA

Facilitating Aftercare for Alcohol Detox Patients

NCT00513708

Alcohol Abuse Alcohol Dependence

COMPLETED NA

Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia

NCT02359487

Alcohol Consumption Alcohol Abuse HIV +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus Hepatitis C Alcohol Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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.

Group Type EXPERIMENTAL

Computer-based alcohol reduction intervention

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.

Clinician-delivered brief MET counseling

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

Group Type ACTIVE_COMPARATOR

Brief clinician-delivered MET

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Standard of care

Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No