Clinical trial NCT02167425: Study of Integrating Antiretroviral Therapy With Methadone Treatment for People Who Inject Drugs
Official title: Reducing Failure-to-Initiate ART Among People Who Inject Drugs: the IMAT Strategy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Opioid Dependence
Keywords: People who Inject Drugs
HIV
Methadone
Sub Saharan Africa
Tanzania
Implementation Science
Lead sponsor: Pangaea Global AIDS Foundation
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Muhimbili University of Health and Allied Sciences
First posted: 2014-06-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to CD4 Screening
timeFrame: Up to 36 months
Secondary outcomes:
measure: Provider Time to Ordering CD4 Screening
timeFrame: Up to 36 months
measure: Percentage of clients that receive CD4 screening within 30 days of HIV-positive test
timeFrame: Up to 36 months
measure: Percentage of eligible (CD4<350) clients that initiate ART within 30 days of CD4 screening
timeFrame: Up to 36 months
measure: Percentage of clients on ART that receive at least 95% ART doses (i.e., adherence)
timeFrame: Up to 36 months
measure: Percentage of patients receiving HIV treatment navigation counseling from provider
timeFrame: Three months pre-intervention and three months post-intervention
measure: Percentage of patients literate in CD4 screening process
timeFrame: Three months pre-intervention and three months post-intervention
measure: Percentage of patients literate in ART Initiation process
timeFrame: Three months pre-intervention and three months post-intervention
measure: Time to ART Initiation
timeFrame: Up to 36 months
Other outcomes:
measure: Percentage of patients satisfied with the quality of services provided
timeFrame: Up to three months post-intervention
measure: Percentage of patients satisfied with confidentiality at the facility
timeFrame: Up to three months post-intervention
measure: Percentage of patients satisfied with the time services are provided
timeFrame: Up to three months post-intervention
measure: Percentage of patients satisfied with waiting times
timeFrame: Up to three months post-intervention
measure: Average waiting time
timeFrame: Up to three months post-intervention
measure: Percentage of patients satisfied with visit times
timeFrame: Up to three months post-intervention
measure: Average visit time
timeFrame: Up to three months post-intervention
measure: Qualitative evaluation of feasibility and acceptability of the IMAT strategy
timeFrame: Up to three months post-intervention
Locations:
Study officials:
affiliation: Pangaea Global AIDS
name: Barrot H Lambdin, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Jessie Mbwambo, MD, PhD
role: STUDY_DIRECTOR
References: