HivPRIDE IIINCT06962033
PRIDE III Prison Interventions and HIV Prevention Collaboration
A study testing Opioid Agonist Therapy in people with Hiv and Opioid Use, run by Yale University at 5 sites in 5 countries.
Trial summary
The primary objective of this research project is to identify barriers to scale-up of Opioid Agonist Therapy (OAT) in the justice systems (prisons and probation) in Tajikistan, Kyrgyzstan, Moldova, and Georgia, and establish a NIATx learning collaborative to scale-up OAT, and analyze scale-up utilizing latent class… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Opioid Use
- What is being tested?
- Opioid Agonist Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 5 Nov 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aim 1:
- Quantitative surveys for prison OAT providers
- Being 18 years or older
- Being currently assigned and working as a probation OAT provider for a probation site
- ECHO procedures
- Aim 2:
Show all 22Show fewer
- Quantitative surveys for people in probation
- Being 18 years or older
- Screen yes to opioid injection on the online screener questionnaire
- Currently in probation
- Quantitative surveys for probation and prison officers
- Being 18 years or older
- Being currently assigned and working as a probation or prison officer at a probation site
- Focus Groups (People in probation)
- Being 18 years or older
- Screen yes to opioid injection criteria on the online screener
- Currently in probation
- Focus Groups (Probation and prison officers)
- Being 18 years or older
- Being currently assigned and working as a probation or prison officer at a probation
- Has more than 3 months of field experience
- Works at a probation site within 25 kilometers of an OAT site
Who cannot join
- -
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Jin Hee Kim, MPH contact
5 sites in 5 countries
United States1 site, 1 recruiting
- Not yet recruiting
Yale University
New Haven, Connecticut, 06520
Kyrgyzstan1 site, 1 recruiting
- Recruiting
AIDS Foundation East-West (AFEW)
Bishkek
Tajikistan1 site, 1 recruiting
- Recruiting
Institute for International Health and Education (IIHE)
Dushanbe
About this study
The primary objective of this research project is to identify barriers to scale-up of Opioid Agonist Therapy (OAT) in the justice systems (prisons and probation) in Tajikistan, Kyrgyzstan, Moldova, and Georgia, and establish a NIATx learning collaborative to scale-up OAT, and analyze scale-up utilizing latent class growth analyses in people who inject drugs (PWID).
Read the detailed description
Aim 1 consists of the development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). This aim is an implementation science aim involving the collection of OAT scale-up data from each country's national OAT database, as well as administration of survey to prison narcologists every 6 months.
Aim 2 consists of the development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. Investigators will collect OAT scale-up data from each member country's national OAT database, and administer a survey to probation officers every 6 months. Investigators will also observe and interview probation clients and staff using ethnographic methods.
- Conditions
- Hiv, Opioid Use
- Being tested
- Opioid Agonist Therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Agonist TherapyBehavioural
Opioid Agonist Therapy (OAT) as HIV prevention
| Study group | Role | What they receive |
|---|---|---|
| Aim 1- Implementation | Experimental | Scale-up Opioid Agonist Therapy (OAT) as HIV prevention in prisons and pre-trial detention centers in EECA for individuals with Opioid Use Disorder (OUD) and link them to community treatment after release using development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). OAT scale-up data will be collected from each country's national OAT database, as well as administration of survey to prison narcologists. Receives: Behavioral: Opioid Agonist Therapy |
| Aim 2- Scale-Up | Experimental | Scale-up OAT as HIV prevention in the newly formed probation system in EECA for individuals with OUD and link them to OAT treatment as part of routine care to align public safety and public health using development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. OAT scale-up data will be collected from each member country's national OAT database, and administer a survey to probation officers. Receives: Behavioral: Opioid Agonist Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants receiving opioid agonist therapy (OAT)
Number of patients receiving opioid agonist therapy (OAT) per OAT site.
Measured: baseline up to 4 years
Secondary outcomes (1)
Adherence to NIATx protocol
Adherence to NIATx protocol: using the NIATx fidelity scale, a 19-item assesment to measure adherence to the NIATx model on a 5-point scale from 1 (No evidence) to 5 (Extensive evidence).
Measured: baseline up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start5 Nov 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
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 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Aim 1: 100 (60 prison OAT providers, 15 per country) for surveys, 40 prison OAT providers, 10 per country, for NGT) Aim 2: 200 (100 probation clients, 100 prison and probation staff (officers and leadership)
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Frederick L Altice, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962033
- Sponsor's protocol ID
- 2000037393
- Other IDs
- 2R01DA029910-11A1
- Acronym
- PRIDE III
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIDE III Prison Interventions and HIV Prevention Collaboration
- ClinicalTrials.gov ID
- NCT06962033
- Acronym / sponsor ID
- PRIDE III / 2000037393
- Conditions
- Hiv, Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 May 2025 (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 primary objective of this research project is to identify barriers to scale-up of Opioid Agonist Therapy (OAT) in the justice systems (prisons and probation) in Tajikistan, Kyrgyzstan, Moldova, and Georgia, and establish a NIATx learning collaborative to scale-up OAT, and analyze scale-up utilizing latent class growth analyses in people who inject drugs (PWID).
Detailed description
Aim 1 consists of the development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). This aim is an implementation science aim involving the collection of OAT scale-up data from each country's national OAT database, as well as administration of survey to prison narcologists every 6 months.
Aim 2 consists of the development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. Investigators will collect OAT scale-up data from each member country's national OAT database, and administer a survey to probation officers every 6 months. Investigators will also observe and interview probation clients and staff using ethnographic methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Aim 1: 100 (60 prison OAT providers, 15 per country) for surveys, 40 prison OAT providers, 10 per country, for NGT) Aim 2: 200 (100 probation clients, 100 prison and probation staff (officers and leadership)
| Arm | Type | Receives |
|---|---|---|
| Aim 1- Implementation | Experimental | Behavioral: Opioid Agonist TherapyScale-up Opioid Agonist Therapy (OAT) as HIV prevention in prisons and pre-trial detention centers in EECA for individuals with Opioid Use Disorder (OUD) and link them to community treatment after release using development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). OAT scale-up data will be collected from each country's national OAT database, as well as administration of survey to prison narcologists. |
| Aim 2- Scale-Up | Experimental | Behavioral: Opioid Agonist TherapyScale-up OAT as HIV prevention in the newly formed probation system in EECA for individuals with OUD and link them to OAT treatment as part of routine care to align public safety and public health using development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. OAT scale-up data will be collected from each member country's national OAT database, and administer a survey to probation officers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Quantitative surveys for prison OAT providers
- ECHO procedures
- Quantitative surveys for people in probation
- Quantitative surveys for probation and prison officers
- Focus Groups (People in probation)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Opioid Agonist TherapyOpioid Agonist Therapy (OAT) as HIV prevention | Behavioural | Aim 1- Implementation, Aim 2- Scale-Up |
Primary outcome
Number of participants receiving opioid agonist therapy (OAT)
Time frame: baseline up to 4 years
Number of patients receiving opioid agonist therapy (OAT) per OAT site.
1 secondary outcome
Adherence to NIATx protocol
Time frame: baseline up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Jin Hee Kim, MPH contact
Frederick L Altice, MD principal investigator
Yale University
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Agonist Therapy in people with Hiv and Opioid Use, run by Yale University at 5 sites in 5 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 22 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Georgia, Kyrgyzstan, Moldova, Tajikistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Oliveros, MPH (202-805-8118, david.oliveros@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants receiving opioid agonist therapy (OAT) (time frame: baseline up to 4 years). 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 10 Sep 2026.