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临床试验/NCT02167425
NCT02167425Unknown不适用

Reducing Failure-to-Initiate ART Among People Who Inject Drugs: the IMAT Strategy

Pangaea Global AIDS Foundation0 个研究点目标入组 800 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
主要终点
Time to CD4 Screening

研究概览

简要总结

To improve ART initiation among people who inject drugs, the investigators propose to develop and pilot a multi-component Integrated Methadone and Antiretroviral Therapy strategy (IMAT) in Dar es Salaam, Tanzania. In doing so, the investigators anticipate building a functional model of methadone and ART integration that improves the effectiveness and efficiency of service delivery.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Time to CD4 Screening

时间窗: Up to 36 months

Number of days between positive HIV test and CD4 screening. Extracted from routine clinical and laboratory monitoring data.

次要结局

  • Percentage of clients that receive CD4 screening within 30 days of HIV-positive test(Up to 36 months)
  • Percentage of eligible (CD4<350) clients that initiate ART within 30 days of CD4 screening(Up to 36 months)
  • Percentage of clients on ART that receive at least 95% ART doses (i.e., adherence)(Up to 36 months)
  • Percentage of patients receiving HIV treatment navigation counseling from provider(Three months pre-intervention and three months post-intervention)
  • Percentage of patients literate in CD4 screening process(Three months pre-intervention and three months post-intervention)
  • Time to ART Initiation(Up to 36 months)
  • Provider Time to Ordering CD4 Screening(Up to 36 months)
  • Percentage of patients literate in ART Initiation process(Three months pre-intervention and three months post-intervention)

研究者

发起方
Pangaea Global AIDS Foundation
申办方类型
Other
责任方
Sponsor

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