Integrering av avhengighetsbehandling og HIV-tjenester i primærpleieklinikker i Ukraina (IMPACT)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Original outcomes were edited and Implementation outcomes were added November 2023.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Kyiv, Ukraina
- European Institute for Public Health Policy
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- PWID
- Interested in MMT
- Meets DSM-V criteria for Opioid Dependence
Exclusion Criteria:
- Not willing to consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Spesialistavhengighetsklinikk
|
|
|
Eksperimentell: ECHO-IC/QI-forbedret primærhelseklinikk
|
Co-location of clinical services for HIV and PWID patients |
|
Aktiv komparator: ECHO-IC/QI-forbedret primærhelseklinikk med Pay for Performance
|
Co-location of clinical services for HIV and PWID patients |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Average Percentage of Recommended Quality Health Indicator Services Accessed by Participants to Assess Efficacy
Tidsramme: 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. |
every 6 months up to 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Average Percentage of Recommended Primary Quality Health Indicator Services Accessed to Assess Efficacy
Tidsramme: every 6 months up to 24 months
|
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. |
every 6 months up to 24 months
|
|
Average Percentage of Recommended Specialty Quality Health Indicator Services Accessed to Assess Efficacy
Tidsramme: every 6 months up to 24 months
|
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. |
every 6 months up to 24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Frederick Altice, MD, Yale University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Blodbårne infeksjoner
- Narkotikarelaterte lidelser
- Urogenitale sykdommer
- Kjønnssykdommer
- Psykiske lidelser
- Sykdommer i immunsystemet
- Infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Stoffrelaterte lidelser
- Kjemisk-induserte lidelser
- Langsomme virussykdommer
- HIV-infeksjoner
- Opioidrelaterte lidelser
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- 2000020067
- 1R01DA043125-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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