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Study of Integrating Antiretroviral Therapy With Methadone Treatment for People Who Inject Drugs (IMAT)

2015年11月19日 更新者:Pangaea Global AIDS Foundation

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

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.

研究概览

地位

未知

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (预期的)

800

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study sites will include the methadone clinics at Muhimbili National Hospital, Mwananyamala Regional Hospital, and Temeke Regional Hospital. The study population includes methadone patients and the providers of clinical services at these facilities.

描述

Inclusion Criteria:

Methadone clients living with HIV but not linked to ART are the primary study population. Inclusion criteria for methadone initiation:

  1. opioid dependence
  2. positive urine screening for opiates.

    Additional inclusion criteria include:

  3. age ≥ 18 years of age
  4. 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

  1. received ART prior to methadone initiation
  2. received a tuberculosis-positive diagnosis
  3. 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.
其他名称:
  • Integrated Methadone and Antiretroviral Therapy
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.
其他名称:
  • Integrated Methadone and Antiretroviral Therapy
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time to CD4 Screening
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Provider Time to Ordering CD4 Screening
大体时间: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
大体时间: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
大体时间: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)
大体时间:Up to 36 months
Collected via routine, programmatic data
Up to 36 months
Percentage of patients receiving HIV treatment navigation counseling from provider
大体时间: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
大体时间: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
大体时间: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
大体时间: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

其他结果措施

结果测量
大体时间
Percentage of patients satisfied with the quality of services provided
大体时间:Up to three months post-intervention
Up to three months post-intervention
Percentage of patients satisfied with confidentiality at the facility
大体时间:Up to three months post-intervention
Up to three months post-intervention
Percentage of patients satisfied with the time services are provided
大体时间:Up to three months post-intervention
Up to three months post-intervention
Percentage of patients satisfied with waiting times
大体时间:Up to three months post-intervention
Up to three months post-intervention
Average waiting time
大体时间:Up to three months post-intervention
Up to three months post-intervention
Percentage of patients satisfied with visit times
大体时间:Up to three months post-intervention
Up to three months post-intervention
Average visit time
大体时间:Up to three months post-intervention
Up to three months post-intervention
Qualitative evaluation of feasibility and acceptability of the IMAT strategy
大体时间:Up to three months post-intervention
Up to three months post-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Barrot H Lambdin, PhD, MPH、Pangaea Global AIDS
  • 研究主任:Jessie Mbwambo, MD, PhD、Muhimbili University of Health and Allied Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年2月1日

初级完成 (预期的)

2017年3月1日

研究完成 (预期的)

2017年3月1日

研究注册日期

首次提交

2014年6月17日

首先提交符合 QC 标准的

2014年6月18日

首次发布 (估计)

2014年6月19日

研究记录更新

最后更新发布 (估计)

2015年11月23日

上次提交的符合 QC 标准的更新

2015年11月19日

最后验证

2015年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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