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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02167425
Other study ID # IMAT-01
Secondary ID R34DA037787
Status Enrolling by invitation
Phase N/A
First received June 17, 2014
Last updated November 19, 2015
Start date February 2015
Est. completion date March 2017

Study information

Verified date November 2015
Source Pangaea Global AIDS Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardTanzania: National Institute for Medical Research
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 800
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
IMAT
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Pangaea Global AIDS Foundation Muhimbili University of Health and Allied Sciences, National Institute on Drug Abuse (NIDA)

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of patients satisfied with the quality of services provided Up to three months post-intervention No
Other Percentage of patients satisfied with confidentiality at the facility Up to three months post-intervention No
Other Percentage of patients satisfied with the time services are provided Up to three months post-intervention No
Other Percentage of patients satisfied with waiting times Up to three months post-intervention No
Other Average waiting time Up to three months post-intervention No
Other Percentage of patients satisfied with visit times Up to three months post-intervention No
Other Average visit time Up to three months post-intervention No
Other Qualitative evaluation of feasibility and acceptability of the IMAT strategy Up to three months post-intervention No
Primary Time to CD4 Screening Number of days between positive HIV test and CD4 screening. Extracted from routine clinical and laboratory monitoring data. Up to 36 months No
Secondary Provider Time to Ordering CD4 Screening Collected via routine, programmatic data Up to 36 months No
Secondary Percentage of clients that receive CD4 screening within 30 days of HIV-positive test Collected via routine, programmatic data Up to 36 months No
Secondary Percentage of eligible (CD4<350) clients that initiate ART within 30 days of CD4 screening Collected via routine, programmatic data Up to 36 months No
Secondary Percentage of clients on ART that receive at least 95% ART doses (i.e., adherence) Collected via routine, programmatic data Up to 36 months No
Secondary Percentage of patients receiving HIV treatment navigation counseling from provider Collected via cross-sectional surveys pre- and post-intervention. Three months pre-intervention and three months post-intervention No
Secondary Percentage of patients literate in CD4 screening process Collected via cross-sectional surveys pre- and post-intervention. Three months pre-intervention and three months post-intervention No
Secondary Percentage of patients literate in ART Initiation process Collected via cross-sectional surveys pre- and post-intervention. Three months pre-intervention and three months post-intervention No
Secondary Time to ART Initiation 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 No
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