NCT05824702

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

April 5, 2023

Last Update Submit

November 5, 2025

Conditions

Keywords

HIVDrug Treatment

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Enrolled in drug treatment

    Enrollment in drug treatment among social network members living with HIV

    3 months

Study Arms (2)

Experimental: Peer education and network support

EXPERIMENTAL

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.

Behavioral: Peer education & communications

comparison: Standard of care of health education

ACTIVE COMPARATOR

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.

Behavioral: Standard of care educational

Interventions

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

Experimental: Peer education and network support

This is an educational equal attention control group

comparison: Standard of care of health education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ukrainian Institute on Public Health Policy

Kiev, Kyiv Oblast, 01001, Ukraine

Location

Study Officials

  • Carl A Latkin, Ph.D.

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not aware of the other condition
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A pilot randomized clinical trial of behavioral intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 24, 2023

Study Start

September 20, 2023

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

November 6, 2025

Record last verified: 2025-11

Locations