HIVNCT05824702
A Social Network Approach for Improving Medication Assisted Treatment and HIV Prevention and Medical Care Among People Who Inject Drugs in Ukraine
A study testing Peer education & communications in people with HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Peer education & communications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUkraine
- Study dates
- 20 Sep 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Persons that are currently psychotic, suicidal, or cognitively impaired such that they cannot provide informed consent will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Ukrainian Institute on Public Health Policy
Kiev, Kyiv Oblast, 01001
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Peer education & communications, Standard of care educational
- Keywords
- HIV, Drug Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer education & communicationsBehavioural
The intervention trains peer educators to promote medication-assisted drug treatment among peer who inject drugs and are living with HIV.
Standard of care educationalBehavioural
This is an educational equal attention control group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of care educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled in drug treatment
Enrollment in drug treatment among social network members living with HIV
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start20 Sep 2023
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot randomized clinical trial of behavioral intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ukrainian Institute on Public Health Policy, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Carl A Latkin, Ph.D., Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824702
- Sponsor's protocol ID
- R34DA051316
- Other IDs
- IRB00024358, R34DA051316
- Status last verified
- Nov 2025
- First submitted
- 5 Apr 2023
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Social Network Approach for Improving Medication Assisted Treatment and HIV
- ClinicalTrials.gov ID
- NCT05824702
- Acronym / sponsor ID
- R34DA051316
- Conditions
- HIV
- Keywords
- HIV, Drug Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Ukrainian Institute on Public Health Policy, National Institute on Drug Abuse (NIDA)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A pilot randomized clinical trial of behavioral intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental: Peer education and network support | Experimental | Behavioral: Peer education & communicationsThe 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. |
| comparison: Standard of care of health education | Active comparator | Behavioral: Standard of care educationalThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Persons that are currently psychotic, suicidal, or cognitively impaired such that they cannot provide informed consent will be excluded from participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer education & communicationsThe intervention trains peer educators to promote medication-assisted drug treatment among peer who inject drugs and are living with HIV. | Behavioural | Experimental: Peer education and network support |
| Standard of care educationalThis is an educational equal attention control group | Behavioural | comparison: Standard of care of health education |
Primary outcome
Number of Participants Enrolled in drug treatment
Time frame: 3 months
Enrollment in drug treatment among social network members living with HIV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl A Latkin, Ph.D. principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer education & communications in people with HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Enrolled in drug treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.