- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02167425
Study of Integrating Antiretroviral Therapy With Methadone Treatment for People Who Inject Drugs (IMAT)
Reducing Failure-to-Initiate ART Among People Who Inject Drugs: the IMAT Strategy
Studienübersicht
Detaillierte Beschreibung
The overarching goal of the proposed research is to develop and test an innovative implementation model (IMAT) for the effective integration of HIV care and treatment with methadone services in Dar es Salaam, Tanzania. The investigators will utilize the PRECEDE framework to inform the intervention to improve linkage of HIV-positive methadone patients to ART. This model suggests that strategies intended to improve health care delivery should consider a combination of three factors: 1) 'predisposing factors' - characteristics such as knowledge, attitudes, beliefs and motivation to change, 2) 'enabling factors' - characteristics that enable someone to act on their desired behavior and 3) 'reinforcing factors' - factors that encourage repetition or persistence of behavior. Therefore, our IMAT approach uses 1) targeted education and mentoring for providers that predispose them to timely ART initiation, 2) POC CD4 count platforms (PIMA, Alere) providing real-time screening and results that enable ART initiation and 3) an alerts and reminder dashboard (e.g., a summary of key indicators for improved decision making) for providers that reinforce ART initiation. Additionally, our approach will lay the foundation for developing implementation strategies for future point-of-care technologies such as viral load.
The study will combine a mixture of qualitative and quantitative methodologies to inform and evaluate the IMAT intervention.
A baseline qualitative study using in-depth interviews will be conducted among providers and methadone clients to understand predisposing, enabling and reinforcing factors related to integration of HIV care and treatment into the methadone clinic. Information gained from these qualitative assessments will inform and support the IMAT strategy. In addition, HIV-positive methadone clients will be randomly selected to complete a baseline cross-sectional survey to collect data on patient satisfaction, access to HIV care, current treatment navigation access, and HIV care literacy.
The investigators will assess the effectiveness of IMAT with a quasi-experimental pre-post cohort design and a pre-post cross-sectional survey to examine changes in patient- and provider-level outcomes after implementation of IMAT compared to before IMAT. In addition, The investigators will assess the feasibility and acceptability of the IMAT strategy using a post-implementation cross-sectional survey with a particular emphasis on satisfaction with services; a time motion study to understand the timeliness of care provision; and in-depth interviews with patients and providers to understand experiences with the IMAT strategy.
Studientyp
Einschreibung (Voraussichtlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
Methadone clients living with HIV but not linked to ART are the primary study population. Inclusion criteria for methadone initiation:
- opioid dependence
positive urine screening for opiates.
Additional inclusion criteria include:
- age ≥ 18 years of age
- HIV-positive. Individuals must also be willing to provide informed consent and be fluent in Kiswahili or English to participate in cross-sectional surveys and in-depth interviews
Exclusion Criteria:
We will exclude methadone clients from this study who have
- received ART prior to methadone initiation
- received a tuberculosis-positive diagnosis
- women who are pregnant. The investigators have excluded clients who have received ART in the past as their inclusion would bias our study results. The investigators have also excluded patients with a tuberculosis diagnosis or women who are pregnant as they have a unique and urgent need for treatment and should be initiated onto ART regardless of their CD4 count
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
Late Post-IMAT Cohort
Enrollment into the Late Post-IMAT Cohort will occur over a 9-month period in beginning in the second year of the intervention and will be followed by a 3-month period of follow-up after the close of enrollment.
|
The IMAT intervention will combine three main strategies: point-of-care (POC) CD4 screening, provider training and mentoring, and an alerts and reminder dashboard.
The POC CD4 platform will provide real-time clinical staging, enabling providers within the methadone clinic to screen HIV-infected patients for ART eligibility.
Coupled with this technology, appropriate training and mentoring will predispose providers to effectively link patients to ART and integration of an alert and reminder dashboard will reinforce behavior change and strengthen processes.
Andere Namen:
|
Early Post-IMAT Cohort
Enrollment into the Early Post-IMAT Cohort will occur over a 9-month period immediately following the intervention and will be followed by a 3-month period of follow-up after the close of enrollment.
|
The IMAT intervention will combine three main strategies: point-of-care (POC) CD4 screening, provider training and mentoring, and an alerts and reminder dashboard.
The POC CD4 platform will provide real-time clinical staging, enabling providers within the methadone clinic to screen HIV-infected patients for ART eligibility.
Coupled with this technology, appropriate training and mentoring will predispose providers to effectively link patients to ART and integration of an alert and reminder dashboard will reinforce behavior change and strengthen processes.
Andere Namen:
|
Late Pre-IMAT Cohort
Enrollment into the Late Pre-IMAT Cohort will begin one year prior to implementation of the intervention.
Enrollment will occur over a 9-month period and will be followed by a 3-month period of follow-up after the close of enrollment.
|
|
Early Pre-IMAT Cohort
Enrollment into the Early Pre-IMAT Cohort will begin two years prior to implementation of the intervention.
Enrollment will occur over a 9-month period and will be followed by a 3-month period of follow-up after the close of enrollment.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to CD4 Screening
Zeitfenster: Up to 36 months
|
Number of days between positive HIV test and CD4 screening.
Extracted from routine clinical and laboratory monitoring data.
|
Up to 36 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Provider Time to Ordering CD4 Screening
Zeitfenster: Up to 36 months
|
Collected via routine, programmatic data
|
Up to 36 months
|
Percentage of clients that receive CD4 screening within 30 days of HIV-positive test
Zeitfenster: Up to 36 months
|
Collected via routine, programmatic data
|
Up to 36 months
|
Percentage of eligible (CD4<350) clients that initiate ART within 30 days of CD4 screening
Zeitfenster: Up to 36 months
|
Collected via routine, programmatic data
|
Up to 36 months
|
Percentage of clients on ART that receive at least 95% ART doses (i.e., adherence)
Zeitfenster: Up to 36 months
|
Collected via routine, programmatic data
|
Up to 36 months
|
Percentage of patients receiving HIV treatment navigation counseling from provider
Zeitfenster: Three months pre-intervention and three months post-intervention
|
Collected via cross-sectional surveys pre- and post-intervention.
|
Three months pre-intervention and three months post-intervention
|
Percentage of patients literate in CD4 screening process
Zeitfenster: Three months pre-intervention and three months post-intervention
|
Collected via cross-sectional surveys pre- and post-intervention.
|
Three months pre-intervention and three months post-intervention
|
Percentage of patients literate in ART Initiation process
Zeitfenster: Three months pre-intervention and three months post-intervention
|
Collected via cross-sectional surveys pre- and post-intervention.
|
Three months pre-intervention and three months post-intervention
|
Time to ART Initiation
Zeitfenster: Up to 36 months
|
Number of Days between receiving a qualifying CD4 count and first dose of ART.
Extracted from routine clinical and laboratory monitoring data.
|
Up to 36 months
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Percentage of patients satisfied with the quality of services provided
Zeitfenster: Up to three months post-intervention
|
Up to three months post-intervention
|
Percentage of patients satisfied with confidentiality at the facility
Zeitfenster: Up to three months post-intervention
|
Up to three months post-intervention
|
Percentage of patients satisfied with the time services are provided
Zeitfenster: Up to three months post-intervention
|
Up to three months post-intervention
|
Percentage of patients satisfied with waiting times
Zeitfenster: Up to three months post-intervention
|
Up to three months post-intervention
|
Average waiting time
Zeitfenster: Up to three months post-intervention
|
Up to three months post-intervention
|
Percentage of patients satisfied with visit times
Zeitfenster: Up to three months post-intervention
|
Up to three months post-intervention
|
Average visit time
Zeitfenster: Up to three months post-intervention
|
Up to three months post-intervention
|
Qualitative evaluation of feasibility and acceptability of the IMAT strategy
Zeitfenster: Up to three months post-intervention
|
Up to three months post-intervention
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Barrot H Lambdin, PhD, MPH, Pangaea Global AIDS
- Studienleiter: Jessie Mbwambo, MD, PhD, Muhimbili University of Health and Allied Sciences
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Chemisch induzierte Störungen
- Substanzbezogene Störungen
- Drogenbezogene Störungen
- Opioidbezogene Störungen
- Physiologische Wirkungen von Arzneimitteln
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Analgetika, Opioide
- Betäubungsmittel
- Atemwegsmittel
- Antitussive Mittel
- Methadon
Andere Studien-ID-Nummern
- IMAT-01
- R34DA037787 (US NIH Stipendium/Vertrag)
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