A Social Network Approach for Improving Medication Assisted Treatment and HIV Prevention and Medical Care Among People Who Inject Drugs in Ukraine

NCT ID: NCT05824702

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2025-09-01

Brief Summary

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The aim of this study is to pilot a peer education for people on medication assisted treatment (MAT). People on MAT will be trained to be peer educators and provide outreach to the educators social network members who inject drugs, some of whom will be HIV positive.

Detailed Description

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The, goal of the intervention is to increase medication assisted treatment (MAT) uptake and retention in order to enhance as well as HIV medical care and antiretroviral therapy (ART) adherence among those social network members who use drugs and those living with HIV who use drugs. The project will quantitatively and qualitatively assess barriers to MAT and ART uptake and adherence, while using peer educators to promote MAT and ART among their network members. Finally, the project aims to determine the effect size for guiding the planning of larger intervention and the feasibility and acceptability of this intervention for HIV prevention and improvement in HIV-related health outcomes among people living with HIV who inject drugs (PLWH PWID). The intervention will be deployed in Ukraine, a setting with high HIV incidence rates among PWID, low levels of viral suppression among HIV positive PWID, and low rates of MAT uptake.

Conditions

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HIV

Keywords

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HIV Drug Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pilot randomized clinical trial of behavioral intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants are not aware of the other condition

Study Groups

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Experimental: Peer education and network support

The intervention sessions will consist of 6 group sessions including 1) Introduction to Peer Educator role and peer Communication skills, 2) HIV and drug treatments, 3) using a decision balance tool with network members for drug treatment, 4) Promoting HIV prevention and medical care \& using text messages as peer educators for promoting MAT and HIV prevention and care, 5) Preventing and responding to relapse, and 6) HIV care retention and medication adherence.

Group Type EXPERIMENTAL

Peer education & communications

Intervention Type BEHAVIORAL

The intervention trains peer educators to promote medication-assisted drug treatment among peer who inject drugs and are living with HIV.

comparison: Standard of care of health education

The comparison condition will include 5 group sessions focused on: 1) retention in MAT by addressing the myths about MAT; 2) information to MAT clients on finding local MAT and other health services in areas where they migrate; 3) importance of HIV prevention (including PreP) and HIV treatment including adherence to HIV; 4) harm reduction, safe drug use, overdose prevention and first aid in case of overdose; 5) addressing Hepatitis C, chronic conditions and mental health issues by emphasizing the importance of timely addressing these health problems and providing information on available local and national services.

Group Type ACTIVE_COMPARATOR

Standard of care educational

Intervention Type BEHAVIORAL

This is an educational equal attention control group

Interventions

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Peer education & communications

The intervention trains peer educators to promote medication-assisted drug treatment among peer who inject drugs and are living with HIV.

Intervention Type BEHAVIORAL

Standard of care educational

This is an educational equal attention control group

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* On methadone for at least 1 year and rated by the staff as low risk for relapse
* Report at least 1 drug network member living with HIV, not on methadone, and seen weekly
* Willing to talk with drug users in their network about medication for drug dependence and accompany them to methadone clinic

Exclusion Criteria

• Persons that are currently psychotic, suicidal, or cognitively impaired such that they cannot provide informed consent will be excluded from participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ukrainian Institute on Public Health Policy

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl A Latkin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Ukrainian Institute on Public Health Policy

Kiev, Kyiv Oblast, Ukraine

Site Status

Countries

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Ukraine

Other Identifiers

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IRB00024358

Identifier Type: OTHER

Identifier Source: secondary_id

R34DA051316

Identifier Type: NIH

Identifier Source: secondary_id

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R34DA051316

Identifier Type: NIH

Identifier Source: org_study_id

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