Opioid-use DisorderMATLINKNCT04947475

Project MATLINK: Development and Evaluation of a Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program for Opioid Dependent Prisoners and Probationers Transitioning to the Community

A study testing SBIRT in people with Opioid-use Disorder and HIV Infections, run by Yale University at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy a Screening, Brief Intervention, and Referral to Treatment (SBIRT) program for linking opioid dependent individuals currently incarcerated or in probation in Moldova, Kyrgyzstan, and Ukraine to opioid substitution therapy in the community after release or during… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid-use Disorder, HIV Infections, Tuberculosis
What is being tested?: SBIRT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 835 participants
Where: 3 sitesin 3 countries
Study dates: 1 Jan 2017to 30 Apr 2023
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

18 years of age or older
Within 180 days of release or possible release (eligible for parole) to the community, but greater than 7 days to release to the community OR currently in probation.
FOR THOSE IN PRISON: Relocating to a location within 30 km (approximately 60-minute commute) of the referred Narcology center. Each participant will be asked the address he/she is planning to reside under that will be immediately checked on the map to determine the travel time. A participant then will be asked if he/she would be willing to travel the distance to a particular OAT site. If a person does not meet this inclusion criterion, he/she will be referred to a local harm reduction center.
Meets ICD-10 screening criteria for pre-incarceration opioid dependence
FOR THOSE IN PROBATION:
Living within 30 km of an OAT delivery site
Not having received OAT in the last 15 days.
Positive for OUD

Who cannot join

Pregnant or may become pregnant
FOR THOSE IN PRISON: Will be released from prison in 7 days or less.

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Kyrgyzstan1 site

AIDS Foundation East-West
Bishkek

Other trials in Kyrgyzstan

Moldova1 site

AFI - Act for Involvement
Chisinau

Other trials in Moldova

Ukraine1 site

Ukrainian Institute for Public Health Policy
Kyiv

Other trials in Ukraine

About this study

Conditions: Opioid-use Disorder, HIV Infections, Tuberculosis, Hepatitis C, Hepatitis B, Depression
Being tested: SBIRT
Keywords: HIV, OUD, Methadone, HCV, HBV, TB, Depression, Syphilis
Medical subject headings: Opioid-Related Disorders, HIV Infections, Tuberculosis, Hepatitis C, Hepatitis B, Depression, Syphilis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SBIRTBehavioural
First, the BI is designed to inform potential participants on the risks of substance misuse, abuse, and dependency by illustrating the potential hazards and adverse health consequences. Second, the BI aims to motivate potential participants to reduce risky behavior (e.g., continued drug use) and seek treatment for their substance dependence disorder. In our BI, we will provide evidence-based information on Opioid Agonist Therapy (OAT) that is available to them in the community upon release or in the community. We will inform them of the risks and benefits of OAT and explain to them how OAT can be accessed in the community. OAT is provided at no cost to Ukrainian, Moldovan, and Kyrgyz citizens with opioid dependence. The BI will last approximately 20 minutes and time will be made available for them to ask questions. The BI will not be audio recorded.

Study groups in NCT04947475
Study group	Role	What they receive
Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program	Experimental	There are two objectives to the Brief Intervention. First, the BI is designed to inform potential participants on the risks of substance misuse, abuse, and dependency by illustrating the potential hazards and adverse health consequences. Second, the BI aims to motivate potential participants to reduce risky behavior (e.g., continued drug use) and seek treatment for their substance dependence disorder. Receives: Behavioral: SBIRT

What is being measured

The primary outcome is the main question the study is designed to answer.

Enrollment on OAT
Total number of participants who enroll on OAT divided by the number of participants who underwent study procedures, per country.
Measured: 12 months

Secondary outcomes (5)

OAT Knowledge
Overall mean change in composite score of knowledge of OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
Measured: 6 month
OAT Attitudes
Overall mean change in composite score of attitudes towards OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
Measured: 6 months
Interest in OAT
Overall mean change in composite score of interest in initiating OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
Measured: 6 months
OAT Difficulty
Overall mean change in composite score of difficulty in initiating OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
Measured: 6 months
OAT Importance
Overall mean change in composite score of importance of initiating OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201730 Apr 2023

First posted1 Jul 2021
Study start1 Jan 2017
Primary completion30 Apr 2023
Study completion30 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 835 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04947475
Sponsor's protocol ID: 1407014374
Other IDs: 2R01DA029910-06
Acronym: MATLINK
Status last verified: May 2025
First submitted: 23 Jun 2021
Last updated: 11 May 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder

All Opioid-use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Project MATLINK: Development and Evaluation of a Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program for Opioid Dependent Prisoners and Probationers Transitioning to the Community
ClinicalTrials.gov ID: NCT04947475
Acronym / sponsor ID: MATLINK / 1407014374
Conditions: Opioid-use Disorder, HIV Infections, Tuberculosis, Hepatitis C, Hepatitis B, Depression
Keywords: HIV, OUD, Methadone, HCV, HBV, TB, Depression, Syphilis
Study type: Interventional
Recruitment status: Completed
Enrolment: 835 participants (estimated)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Ukrainian Institute on Public Health Policy, AFEW Kyrgyzstan, AFI - Act For Involvement, National Institute on Drug Abuse (NIDA)
Study start: 1 Jan 2017 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 30 Apr 2023 (actual)
First posted: 1 Jul 2021 (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.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program	Experimental	Behavioral: SBIRTThere are two objectives to the Brief Intervention. First, the BI is designed to inform potential participants on the risks of substance misuse, abuse, and dependency by illustrating the potential hazards and adverse health consequences. Second, the BI aims to motivate potential participants to reduce risky behavior (e.g., continued drug use) and seek treatment for their substance dependence disorder.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

18 years of age or older
Within 180 days of release or possible release (eligible for parole) to the community, but greater than 7 days to release to the community OR currently in probation.
FOR THOSE IN PRISON: Relocating to a location within 30 km (approximately 60-minute commute) of the referred Narcology center. Each participant will be asked the address he/she is planning to reside under that will be immediately checked on the map to determine the travel time. A participant then will be asked if he/she would be willing to travel the distance to a particular OAT site. If a person does not meet this inclusion criterion, he/she will be referred to a local harm reduction center.
Meets ICD-10 screening criteria for pre-incarceration opioid dependence
Living within 30 km of an OAT delivery site

Key exclusion criteria (2 listed)

Pregnant or may become pregnant
FOR THOSE IN PRISON: Will be released from prison in 7 days or less.

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
SBIRTFirst, the BI is designed to inform potential participants on the risks of substance misuse, abuse, and dependency by illustrating the potential hazards and adverse health consequences. Second, the BI aims to motivate potential participants to reduce risky behavior (e.g., continued drug use) and seek treatment for their substance dependence disorder. In our BI, we will provide evidence-based information on Opioid Agonist Therapy (OAT) that is available to them in the community upon release or in the community. We will inform them of the risks and benefits of OAT and explain to them how OAT can be accessed in the community. OAT is provided at no cost to Ukrainian, Moldovan, and Kyrgyz citizens with opioid dependence. The BI will last approximately 20 minutes and time will be made available for them to ask questions. The BI will not be audio recorded.	Behavioural	Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program

Primary outcome

Enrollment on OAT
Time frame: 12 months
Total number of participants who enroll on OAT divided by the number of participants who underwent study procedures, per country.

5 secondary outcomes

OAT Knowledge
Time frame: 6 month
OAT Attitudes
Time frame: 6 months
Interest in OAT
Time frame: 6 months
OAT Difficulty
Time frame: 6 months
OAT Importance
Time frame: 6 months

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 11 May 2025.
Individual participant dataSharing planned: Undecided

Related trials for Opioid-use Disorder

Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-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.

Frederick L Altice, MD principal investigator

Yale University

Natalya Shumskaya study director

AIDS Foundation East-West

Nataliia Saishuk study director

Ukrainian Institute for Public Health Policy

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SBIRT in people with Opioid-use Disorder and HIV Infections, run by Yale University at 3 sites in 3 countries.

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 8 inclusion and 2 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 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Kyrgyzstan, Moldova, 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?

Enrollment on OAT (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04947475.

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 11 May 2025.