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

2015년 11월 19일 업데이트: 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.

연구 개요

상태

알려지지 않은

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (예상)

800

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
다른 이름들:
  • 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.
다른 이름들:
  • 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time to CD4 Screening
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Provider Time to Ordering CD4 Screening
기간: 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
기간: 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
기간: 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)
기간: Up to 36 months
Collected via routine, programmatic data
Up to 36 months
Percentage of patients receiving HIV treatment navigation counseling from provider
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
기간
Percentage of patients satisfied with the quality of services provided
기간: Up to three months post-intervention
Up to three months post-intervention
Percentage of patients satisfied with confidentiality at the facility
기간: Up to three months post-intervention
Up to three months post-intervention
Percentage of patients satisfied with the time services are provided
기간: Up to three months post-intervention
Up to three months post-intervention
Percentage of patients satisfied with waiting times
기간: Up to three months post-intervention
Up to three months post-intervention
Average waiting time
기간: Up to three months post-intervention
Up to three months post-intervention
Percentage of patients satisfied with visit times
기간: Up to three months post-intervention
Up to three months post-intervention
Average visit time
기간: Up to three months post-intervention
Up to three months post-intervention
Qualitative evaluation of feasibility and acceptability of the IMAT strategy
기간: Up to three months post-intervention
Up to three months post-intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Barrot H Lambdin, PhD, MPH, Pangaea Global AIDS
  • 연구 책임자: Jessie Mbwambo, MD, PhD, Muhimbili University of Health and Allied Sciences

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 2월 1일

기본 완료 (예상)

2017년 3월 1일

연구 완료 (예상)

2017년 3월 1일

연구 등록 날짜

최초 제출

2014년 6월 17일

QC 기준을 충족하는 최초 제출

2014년 6월 18일

처음 게시됨 (추정)

2014년 6월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 11월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 11월 19일

마지막으로 확인됨

2015년 11월 1일

추가 정보

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