HIVIMATNCT02167425
Study of Integrating Antiretroviral Therapy With Methadone Treatment for People Who Inject Drugs
An observational study of HIV and Opioid Dependence, run by Pangaea Global AIDS Foundation.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Opioid Dependence
- What is being tested?
- IMAT
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Opioid Dependence
- Being tested
- IMAT
- Keywords
- People who Inject Drugs, HIV, Methadone, Sub Saharan Africa, Tanzania, Implementation Science
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMATOther
Also called Integrated Methadone and Antiretroviral Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: IMAT | |
| 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. Receives: Other: IMAT | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to CD4 Screening
Number of days between positive HIV test and CD4 screening. Extracted from routine clinical and laboratory monitoring data.
Measured: Up to 36 months
Secondary outcomes (8)
Provider Time to Ordering CD4 Screening
Collected via routine, programmatic data
Measured: Up to 36 months
Percentage of clients that receive CD4 screening within 30 days of HIV-positive test
Collected via routine, programmatic data
Measured: Up to 36 months
Percentage of eligible (CD4<350) clients that initiate ART within 30 days of CD4 screening
Collected via routine, programmatic data
Measured: Up to 36 months
Percentage of clients on ART that receive at least 95% ART doses (i.e., adherence)
Collected via routine, programmatic data
Measured: Up to 36 months
Percentage of patients receiving HIV treatment navigation counseling from provider
Collected via cross-sectional surveys pre- and post-intervention.
Measured: Three months pre-intervention and three months post-intervention
Percentage of patients literate in CD4 screening process
Collected via cross-sectional surveys pre- and post-intervention.
Measured: Three months pre-intervention and three months post-intervention
Percentage of patients literate in ART Initiation process
Collected via cross-sectional surveys pre- and post-intervention.
Measured: Three months pre-intervention and three months post-intervention
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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pangaea Global AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Barrot H Lambdin, PhD, MPH, Principal investigator, Pangaea Global AIDSJessie Mbwambo, MD, PhD, Study director, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167425
- Sponsor's protocol ID
- IMAT-01
- Other IDs
- R34DA037787
- Acronym
- IMAT
- Status last verified
- Nov 2015
- First submitted
- 17 Jun 2014
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Failure-to-Initiate ART Among People Who Inject Drugs: the IMAT Strategy
- ClinicalTrials.gov ID
- NCT02167425
- Acronym / sponsor ID
- IMAT / IMAT-01
- Conditions
- HIV, Opioid Dependence
- Keywords
- People who Inject Drugs, HIV, Methadone, Sub Saharan Africa, Tanzania, Implementation Science
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Pangaea Global AIDS FoundationUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Muhimbili University of Health and Allied Sciences
- Study start
- Feb 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Late Post-IMAT Cohort | – | Other: IMATEnrollment 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. |
| Early Post-IMAT Cohort | – | Other: IMATEnrollment 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMATAlso: Integrated Methadone and Antiretroviral TherapyThe 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. | Other | Early Post-IMAT Cohort, Late Post-IMAT Cohort |
Primary outcome
Time to CD4 Screening
Time frame: Up to 36 months
Number of days between positive HIV test and CD4 screening. Extracted from routine clinical and laboratory monitoring data.
8 secondary outcomes
Provider Time to Ordering CD4 Screening
Time frame: Up to 36 months
Percentage of clients that receive CD4 screening within 30 days of HIV-positive test
Time frame: Up to 36 months
Percentage of eligible (CD4<350) clients that initiate ART within 30 days of CD4 screening
Time frame: Up to 36 months
Percentage of clients on ART that receive at least 95% ART doses (i.e., adherence)
Time frame: Up to 36 months
Percentage of patients receiving HIV treatment navigation counseling from provider
Time frame: Three months pre-intervention and three months post-intervention
Percentage of patients literate in CD4 screening process
Time frame: Three months pre-intervention and three months post-intervention
Percentage of patients literate in ART Initiation process
Time frame: Three months pre-intervention and three months post-intervention
Time to ART Initiation
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barrot H Lambdin, PhD, MPH principal investigator
Pangaea Global AIDS
Jessie Mbwambo, MD, PhD study director
Muhimbili University of Health and Allied Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Opioid Dependence, run by Pangaea Global AIDS Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to CD4 Screening (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.