NCT03362476

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

September 1, 2022

Enrollment Period

4.2 years

First QC Date

November 30, 2017

Results QC Date

April 24, 2023

Last Update Submit

December 16, 2024

Conditions

Human Immunodeficiency VirusHepatitis CAlcohol Abuse

Keywords

Human Immunodeficiency VirusHepatitis CComputer InterventionAlcoholismWomenRussia

Outcome Measures

Primary Outcomes (1)

  • 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.

    3-, 6-, and 9-month post-baseline

Secondary Outcomes (5)

  • Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL)

    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

    9-month post-baseline

  • CD4 Cell Count

    9-month post-baseline

  • Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline

    9-month post-baseline

  • Liver Stiffness

    9-month post-baseline

Study Arms (2)

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

EXPERIMENTAL

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 interventionBehavioral: Brief clinician-delivered METBehavioral: Standard of care

Clinician-delivered brief MET counseling

ACTIVE COMPARATOR

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

Behavioral: Brief clinician-delivered METBehavioral: Standard of care

Interventions

Computer-based alcohol reduction interventionBEHAVIORAL

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.

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

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.

Clinician-delivered brief MET counselingComputer-based alcohol reduction intervention + Clinician-delivered brief MET counseling
Standard of careBEHAVIORAL

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

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

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York University

New York, New York, 10003, United States

Location

North West District AIDS Center

Saint Petersburg, 197376, Russia

Location

Related Publications (3)

  • DiClemente RJ, Brown JL, Capasso A, Revzina N, Sales JM, Boeva E, Gutova LV, Khalezova NB, Belyakov N, Rassokhin V. Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial. Trials. 2021 Feb 17;22(1):147. doi: 10.1186/s13063-021-05079-x.

    PMID: 33596972BACKGROUND

  • Khalezova NB, Capasso A, Boeva EV, Gutova LV, Rassokhin VV, Neznanov NG, Belyakov NA, Brown JL, DiClemente RJ. Situational and motivational factors associated with unhealthy alcohol use among Russian women with HIV and hepatitis C Virus co-infection. Drug Alcohol Depend Rep. 2022 Jun;3:100053. doi: 10.1016/j.dadr.2022.100053. Epub 2022 Apr 14.

    PMID: 35783993BACKGROUND

  • Brown JL, Anastasakis I, Revzina N, Capasso A, Boeva E, Rassokhin V, Crusey A, Sales JM, Hitch A, Renfro T, DiClemente RJ. Development and Cultural Adaptation of a Computer-Delivered and Multi-Component Alcohol Reduction Intervention for Russian Women Living with HIV and HCV. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211044920. doi: 10.1177/23259582211044920.

    PMID: 34668412BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHepatitis CAlcoholism

Interventions

EthanolStandard of Care

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Ralph J DiClemente
Organization
New York University
rjd438@nyu.edu
+1 (212) 992-3709

Study Officials

  • Ralph J Diclemente, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 5, 2017

Study Start

January 3, 2018

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

January 9, 2025

Results First Posted

January 9, 2025

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Deidentified (IPD) collected in this study will be made available to other researchers.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Will be shared upon request by investigators
Access Criteria
Request from researcher to the PIs for use explaining nature of use; use must be for research purposes; willingness to share eventual abstracts and/or publications with the PIs

Locations

RU(1)US(1)