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Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial (EHOST)

24. April 2017 aktualisiert von: Bohdan Nosyk, Simon Fraser University

The Expanded HIV Care in Opioid Substitution Treatment (EHOST) Stepped-wedge, Cluster-randomized Trial

Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and linkage to antiretroviral treatment. The EHOST study will evaluate a prescriber-focused intervention to increase HIV testing rates, and optimize antiretroviral treatment, re-engagement and retention outcomes among individuals engaged in OST. 46 OST sites in British Columbia will be randomly allocated into three clusters. Clusters will initiative the intervention at different time points, or steps, with every cluster receiving the intervention.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The public health response to the HIV/AIDS epidemic has turned its focus on means of optimizing health care delivery, and re-engineering delivery systems to maximize case identification, as well as access and sustained engagement in antiretroviral treatment. Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and linkage to antiretroviral treatment. The EHOST study is a cluster-randomized, stepped-wedge trial to evaluate a prescriber-focused intervention to increase HIV testing rates, and optimize antiretroviral treatment re-engagement and retention outcomes among individuals engaged in OST. The study will encompass all drug treatment clinics currently admitting patients for the treatment of opioid dependence across the province of British Columbia, which are thought to treat 90% of the OST caseload. The trial will be executed over a 24-month period, with groups of clinics receiving the intervention in 6-month intervals. Evaluation of the effectiveness of the proposed intervention will be conducted entirely through existing data collection mechanisms, and focuses on three primary outcomes: (i) the HIV testing rate among those not known to be HIV positive; (ii) the rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART; and (iii) the rate of HAART continuation among those on HAART. Despite the randomized delivery of the intervention, a difference-in-differences analytical framework will be applied to adjust for potential residual heterogeneity in patient case mix, volume, and quality of care across OST clinics. Facilitated by established collaborations between key stakeholders across the province, we hypothesize that the EHOST intervention will optimize HIV testing and care within this marginalized and hard-to-reach population.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

49

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Drug treatment clinic currently admitting patients for the treatment of opioid dependence across the province of British Columbia

Exclusion Criteria:

  • Private office-based setting

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Cluster 1
Cluster 1 is the first OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the sixth month of the trial. Cluster 1 will be a 'no intervention' arm in the first 6 months of the study, and will cross-over to an experimental arm for months 6-24.
Sonstiges: Expanded HIV care in Opioid Substitution Treatment
The EHOST intervention entails in-person presentations and consultation sessions with individual OST sites that will: (i) provide rationale for the study (ii) outline action items of the intervention; and (iii) describe guidelines around HIV testing and care. The EHOST intervention will be delivered at three distinct times: (i) at point of OST entry; (ii) following 7 days non-adherence; and (iii) at bi-annual intervals. The interventions are comprised of HIV test offers for individuals of unknown HIV status; offers of HIV-related care, including cluster of differentiation 4 (CD4), plasma viral load (pVL) and resistance tests, along with HAART initiation for those known to be HIV-positive, not on HAART; and regular monitoring for those known to be HIV positive, on HAART.
Sonstiges: Cluster 2
Cluster 2 is the second OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the twelfth month of the trial. Cluster 2 will be a 'no intervention' arm in the first 12 months of the study, and will cross-over to a experimental arm for month 12-24.
Sonstiges: Expanded HIV care in Opioid Substitution Treatment
The EHOST intervention entails in-person presentations and consultation sessions with individual OST sites that will: (i) provide rationale for the study (ii) outline action items of the intervention; and (iii) describe guidelines around HIV testing and care. The EHOST intervention will be delivered at three distinct times: (i) at point of OST entry; (ii) following 7 days non-adherence; and (iii) at bi-annual intervals. The interventions are comprised of HIV test offers for individuals of unknown HIV status; offers of HIV-related care, including cluster of differentiation 4 (CD4), plasma viral load (pVL) and resistance tests, along with HAART initiation for those known to be HIV-positive, not on HAART; and regular monitoring for those known to be HIV positive, on HAART.
Sonstiges: Cluster 3
Cluster 3 is the final OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the 18th month of the trial. As such, Cluster 3 will be a 'no intervention' arm in the first 18 months of the study, and will cross-over to an experimental arm for months 18-24.
Sonstiges: Expanded HIV care in Opioid Substitution Treatment
The EHOST intervention entails in-person presentations and consultation sessions with individual OST sites that will: (i) provide rationale for the study (ii) outline action items of the intervention; and (iii) describe guidelines around HIV testing and care. The EHOST intervention will be delivered at three distinct times: (i) at point of OST entry; (ii) following 7 days non-adherence; and (iii) at bi-annual intervals. The interventions are comprised of HIV test offers for individuals of unknown HIV status; offers of HIV-related care, including cluster of differentiation 4 (CD4), plasma viral load (pVL) and resistance tests, along with HAART initiation for those known to be HIV-positive, not on HAART; and regular monitoring for those known to be HIV positive, on HAART.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
The HIV testing rate among those not known to be HIV positive
Zeitfenster: 24 months
24 months
The rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART
Zeitfenster: 24 months
24 months
The rate of HAART adherence among those on HAART
Zeitfenster: 24 months
24 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Simon Fraser University

Mitarbeiter

BC Centre for Excellence in HIV/AIDS

Ermittler

  • Hauptermittler: Bohdan Nosyk, PhD, Simon Fraser University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. September 2015

Primärer Abschluss (Tatsächlich)

1. März 2017

Studienabschluss (Tatsächlich)

1. März 2017

Studienanmeldedaten

Zuerst eingereicht

24. März 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Mai 2015

Zuerst gepostet (Schätzen)

12. Mai 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. April 2017

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MOP313184

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