HivIMPACTNCT04927091

Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine

A study testing Integration of HIV and PWID services in people with Hiv and Opioid-use Disorder, run by Yale University at 1 site in Ukraine.

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

A randomized controlled trial to: 1. To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hiv, Opioid-use Disorder
What is being tested?: Integration of HIV and PWID services
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,590 participants
Where: 1 siteUkraine
Study dates: 1 May 2017to 30 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

PWID
Interested in MMT
Meets DSM-V criteria for Opioid Dependence

Who cannot join

Not willing to consent

Trial locations and contacts

1 site in 1 country.

Ukraine1 site

European Institute for Public Health Policy
Kyiv

Other trials in Ukraine

About this study

A randomized controlled trial to:

To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. After stratifying PWIDs based on their current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) pay for performance (P4P) incentives.
Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) QHI scores.

Read the detailed description

Original outcomes were edited and Implementation outcomes were added November 2023.

Conditions: Hiv, Opioid-use Disorder
Being tested: Integration of HIV and PWID services
Medical subject headings: Acquired Immunodeficiency Syndrome, Opioid-Related Disorders

What participants receive

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

Integration of HIV and PWID servicesOther
Co-location of clinical services for HIV and PWID patients

Study groups in NCT04927091
Study group	Role	What they receive
Specialty Addiction Clinic	No intervention	Not described
ECHO-IC/QI-enhanced primary care clinic	Experimental	Not described Receives: Other: Integration of HIV and PWID services
ECHO-IC/QI-enhanced primary care clinic with Pay for Performance	Active comparator	Not described Receives: Other: Integration of HIV and PWID services

What is being measured

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

Average Percentage of Recommended Quality Health Indicator Services Accessed by Participants to Assess Efficacy
The total average percentage of the 17 recommended Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: General medical examination; blood analysis; urine analysis; cardiogram; mammogram; cervical cancer screening; prostate cancer screening; hepatitis B screening; hepatitis C screening; HIV screening; CD4 or viral load; ART treatment; TB screening; TB treatment; received take-home MMT; adequate MMT dose; on MMT for 12 months. Data presented here is for adjusted average values of services accessed at 24 months.
Measured: every 6 months up to 24 months

Secondary outcomes (2)

Average Percentage of Recommended Primary Quality Health Indicator Services Accessed to Assess Efficacy
The total average percentage of Primary Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: HIV screening; CD4 or viral load; ART treatment. Data presented here is for adjusted average values of services accessed at 24 months.
Measured: every 6 months up to 24 months
Average Percentage of Recommended Specialty Quality Health Indicator Services Accessed to Assess Efficacy
The total average percentage of Specialty(encompasses HIV, TB and MMT) Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: received take-home MMT; adequate MMT dose; on MMT for 12 months. Data presented here is for adjusted average values of services accessed at 24 months.
Measured: every 6 months up to 24 months

Timeline

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

1 May 201730 Jun 2024

First posted15 Jun 2021
Study start1 May 2017
Primary completion30 Jun 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,590 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04927091
Sponsor's protocol ID: 2000020067
Other IDs: 1R01DA043125-01
Acronym: IMPACT
Status last verified: Aug 2026
First submitted: 10 Jun 2021
Last updated: 23 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Machavariani E, Esserman D, Dumchev K, Filippovych M, Pykalo I, Ivasiy R, Madden LM, Bromberg DJ, Haddad M, Morozova O, Oliveros D, Ahmad B, Dvoriak S, Altice FL. Integrating Methadone Services Into Primary Care in Ukraine: Two-Year Outcomes From a Randomized Trial. Ann Intern Med. 2026 Feb;179(2):177-186. doi: 10.7326/ANNALS-25-01764. Epub 2025 Dec 9.
PubMed 41359964
Machavariani E, Bromberg DJ, Dumchev K, Esserman D, Earnshaw VA, Pykalo I, Filippovich M, Ivasiy R, Ahmad B, Long J, Haddad MS, Madden LM, Oliveros D, Dvoriak S, Altice FL. Decrease in provider stigma is associated with improved quality health indicators among individuals receiving methadone in primary care centers in Ukraine. Int J Drug Policy. 2025 Feb;136:104682. doi: 10.1016/j.drugpo.2024.104682. Epub 2024 Dec 19.
PubMed 39705875
Machavariani E, Dumchev K, Pykalo I, Filippovych M, Ivasiy R, Esserman D, Madden LM, Bromberg DJ, Haddad M, Morozova O, Ahmad B, Gomez DO, Farnum SO, Dvoriak S, Altice FL. Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine. Contemp Clin Trials. 2024 Nov;146:107690. doi: 10.1016/j.cct.2024.107690. Epub 2024 Sep 14.
PubMed 39265780
Pashchenko O, Bromberg DJ, Dumchev K, LaMonaca K, Pykalo I, Filippovych M, Esserman D, Polonsky M, Galvez de Leon SJ, Morozova O, Dvoriak S, Altice FL. Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial. PLOS Glob Public Health. 2022 Nov 2;2(11):e0000344. doi: 10.1371/journal.pgph.0000344. eCollection 2022.
PubMed 36962514

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

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All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine
ClinicalTrials.gov ID: NCT04927091
Acronym / sponsor ID: IMPACT / 2000020067
Conditions: Hiv, Opioid-use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,590 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Ukrainian Institute on Public Health Policy, National Institute on Drug Abuse (NIDA)
Study start: 1 May 2017 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 15 Jun 2021 (actual)
Results: Posted 23 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A randomized controlled trial to:

To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. After stratifying PWIDs based on their current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) pay for performance (P4P) incentives.
Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) QHI scores.

Detailed description

Original outcomes were edited and Implementation outcomes were added November 2023.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Specialty Addiction Clinic	No intervention	–
ECHO-IC/QI-enhanced primary care clinic	Experimental	Other: Integration of HIV and PWID services
ECHO-IC/QI-enhanced primary care clinic with Pay for Performance	Active comparator	Other: Integration of HIV and PWID 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)

PWID
Interested in MMT
Meets DSM-V criteria for Opioid Dependence

Key exclusion criteria (1 listed)

Not willing to consent

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
Integration of HIV and PWID servicesCo-location of clinical services for HIV and PWID patients	Other	ECHO-IC/QI-enhanced primary care clinic, ECHO-IC/QI-enhanced primary care clinic with Pay for Performance

Primary outcome

Average Percentage of Recommended Quality Health Indicator Services Accessed by Participants to Assess Efficacy
Time frame: every 6 months up to 24 months
The total average percentage of the 17 recommended Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: General medical examination; blood analysis; urine analysis; cardiogram; mammogram; cervical cancer screening; prostate cancer screening; hepatitis B screening; hepatitis C screening; HIV screening; CD4 or viral load; ART treatment; TB screening; TB treatment; received take-home MMT; adequate MMT dose; on MMT for 12 months. Data presented here is for adjusted average values of services accessed at 24 months.

2 secondary outcomes

Average Percentage of Recommended Primary Quality Health Indicator Services Accessed to Assess Efficacy
Time frame: every 6 months up to 24 months
Average Percentage of Recommended Specialty Quality Health Indicator Services Accessed to Assess Efficacy
Time frame: every 6 months up to 24 months

Results and safety

Results posted to the registry on 23 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Care Centers	950	696
Specialty Addiction Treatment Clinics	509	379

Primary outcome: Average Percentage of Recommended Quality Health Indicator Services Accessed by Participants to Assess Efficacy

Time frame: every 6 months up to 24 months. Mean (95% Confidence Interval). Unit: percent services accessed

Measure	Primary Care Centers n = 950	Specialty Addiction Treatment Clinics n = 509
Value	63.8 (62.3 to 65.3)	54.7 (52.8 to 56.6)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Care Centers	0 of 950 (0%)	0 of 950 (0%)	102 of 950
Specialty Addiction Treatment Clinics	0 of 509 (0%)	0 of 509 (0%)	49 of 509

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41359964Machavariani E, Esserman D, Dumchev K, Filippovych M, Pykalo I, Ivasiy R, Madden LM, Bromberg DJ, Haddad M, Morozova O, Oliveros D, Ahmad B, Dvoriak S, Altice FL. Integrating Methadone Services Into Primary Care in Ukraine: Two-Year Outcomes From a Randomized Trial. Ann Intern Med. 2026 Feb;179(2):177-186. doi: 10.7326/ANNALS-25-01764. Epub 2025 Dec 9.
Derived from this study: PubMed 39705875Machavariani E, Bromberg DJ, Dumchev K, Esserman D, Earnshaw VA, Pykalo I, Filippovich M, Ivasiy R, Ahmad B, Long J, Haddad MS, Madden LM, Oliveros D, Dvoriak S, Altice FL. Decrease in provider stigma is associated with improved quality health indicators among individuals receiving methadone in primary care centers in Ukraine. Int J Drug Policy. 2025 Feb;136:104682. doi: 10.1016/j.drugpo.2024.104682. Epub 2024 Dec 19.
Derived from this study: PubMed 39265780Machavariani E, Dumchev K, Pykalo I, Filippovych M, Ivasiy R, Esserman D, Madden LM, Bromberg DJ, Haddad M, Morozova O, Ahmad B, Gomez DO, Farnum SO, Dvoriak S, Altice FL. Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine. Contemp Clin Trials. 2024 Nov;146:107690. doi: 10.1016/j.cct.2024.107690. Epub 2024 Sep 14.
Derived from this study: PubMed 36962514Pashchenko O, Bromberg DJ, Dumchev K, LaMonaca K, Pykalo I, Filippovych M, Esserman D, Polonsky M, Galvez de Leon SJ, Morozova O, Dvoriak S, Altice FL. Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial. PLOS Glob Public Health. 2022 Nov 2;2(11):e0000344. doi: 10.1371/journal.pgph.0000344. eCollection 2022.
Individual participant dataSharing planned: No

Related trials for Hiv

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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. This study is not recruiting at the moment.

Frederick Altice, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Integration of HIV and PWID services in people with Hiv and Opioid-use Disorder, run by Yale University 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 23 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 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?

Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Average Percentage of Recommended Quality Health Indicator Services Accessed by Participants to Assess Efficacy (time frame: every 6 months up to 24 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 NCT04927091, which also lists 4 linked publications.

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 23 Sep 2026.