- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05824702
A Social Network Approach for Improving Medication Assisted Treatment and HIV Prevention and Medical Care Among People Who Inject Drugs in Ukraine
September 28, 2023 updated by: Johns Hopkins Bloomberg School of Public Health
A Social Network Approach for Improving Medication Assisted Treatment and HIV
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carl A Latkin, Ph.D.
- Phone Number: 14109295461
- Email: carl.latkin@jhu.edu
Study Contact Backup
- Name: Lauren Dayton, PhD
- Phone Number: 4109553972
- Email: ldayton2@jhu.edu
Study Locations
-
-
Kyiv
-
Kiev, Kyiv, Ukraine, 01001
- Recruiting
- Ukrainian Institute on Public Health Policy
-
Contact:
- Oleksandr Zeziulin, MD
- Phone Number: 38 044 587 5061
- Email: zeziulin@uiphp.org.ua
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
The intervention trains peer educators to promote medication-assisted drug treatment among peer who inject drugs and are living with HIV.
|
Active Comparator: 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.
|
This is an educational equal attention control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Enrolled in drug treatment
Time Frame: 3 months
|
Enrollment in drug treatment among social network members living with HIV
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carl A Latkin, Ph.D., Johns Hopkins Bloomberg School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
April 5, 2023
First Submitted That Met QC Criteria
April 6, 2023
First Posted (Actual)
April 24, 2023
Study Record Updates
Last Update Posted (Actual)
October 2, 2023
Last Update Submitted That Met QC Criteria
September 28, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R34DA051316 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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