- ICH GCP
- Registr klinických studií v USA
- Klinická 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
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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.
Ostatní jména:
|
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.
Ostatní jména:
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Time to CD4 Screening
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Provider Time to Ordering CD4 Screening
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: Up to 36 months
|
Collected via routine, programmatic data
|
Up to 36 months
|
Percentage of patients receiving HIV treatment navigation counseling from provider
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Percentage of patients satisfied with the quality of services provided
Časové okno: Up to three months post-intervention
|
Up to three months post-intervention
|
Percentage of patients satisfied with confidentiality at the facility
Časové okno: Up to three months post-intervention
|
Up to three months post-intervention
|
Percentage of patients satisfied with the time services are provided
Časové okno: Up to three months post-intervention
|
Up to three months post-intervention
|
Percentage of patients satisfied with waiting times
Časové okno: Up to three months post-intervention
|
Up to three months post-intervention
|
Average waiting time
Časové okno: Up to three months post-intervention
|
Up to three months post-intervention
|
Percentage of patients satisfied with visit times
Časové okno: Up to three months post-intervention
|
Up to three months post-intervention
|
Average visit time
Časové okno: Up to three months post-intervention
|
Up to three months post-intervention
|
Qualitative evaluation of feasibility and acceptability of the IMAT strategy
Časové okno: Up to three months post-intervention
|
Up to three months post-intervention
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Barrot H Lambdin, PhD, MPH, Pangaea Global AIDS
- Ředitel studie: Jessie Mbwambo, MD, PhD, Muhimbili University of Health and Allied Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Duševní poruchy
- Chemicky indukované poruchy
- Poruchy související s látkami
- Poruchy související s narkotiky
- Poruchy související s opioidy
- Fyziologické účinky léků
- Depresiva centrálního nervového systému
- Agenti periferního nervového systému
- Analgetika
- Agenti smyslového systému
- Analgetika, opiáty
- Narkotika
- Agenti dýchacího systému
- Antitusika
- Metadon
Další identifikační čísla studie
- IMAT-01
- R34DA037787 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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