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Gathering Records to Evaluate Antiretroviral Treatment-Malawi ( GREAT ) (GREAT)

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ClinicalTrials.gov Identifier: NCT04158895
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : December 27, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
University of Witwatersrand, South Africa
Clinton Health Access Initiative Inc.
Information provided by (Responsible Party):
Sydney Rosen, Boston University

Brief Summary:

To achieve global goals for the treatment of HIV, most high-prevalence countries are experimenting with and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries, however, we have little evidence on the big picture—the proportion of clinics offering alternative models, eligibility criteria and the proportion of patients considered eligible, the number of patients actually participating, health outcomes such as viral suppression, empirical resource utilization compared to traditional care, variations among the models, duration of patient participation, fidelity to model guidelines, effects on clinic efficiency, and sustainability without external donor support.

AMBIT is a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery in the future. The project will collect and analyze a wide range of existing data sets pertinent to DSD. This protocol is for an analysis of existing medical record data collected by the Ministry of Health, implementing partners, and other completed, ongoing, or new evaluations, trials, and observational studies. Outcomes to be reported include coverage/uptake of DSD, patients' outcomes, and distribution of each model. There will be no study interaction with individual patients, providers, caregivers, or others for this analysis.


Condition or disease Intervention/treatment
HIV Other: Routine medical record data collection

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Study Type : Observational
Estimated Enrollment : 1000000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Existing Medical Record Data to Evaluate Coverage, Uptake, Benefits, and Costs of Differentiated Models of Service Delivery for HIV Treatment in Africa (Malawi)
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Patients enrolled in differentiated service delivery models Other: Routine medical record data collection
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.

Patients not enrolled in DSD models Other: Routine medical record data collection
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.




Primary Outcome Measures :
  1. Patient-months enrolled in any DSD model [ Time Frame: 12 months ]
    % of all patient-months of ART provided for the cohort that are provided within DSD models

  2. Patient-months enrolled in any DSD model [ Time Frame: 24 months ]
    % of all patient-months of ART provided for the cohort that are provided within DSD models

  3. Patient-months enrolled in any DSD model [ Time Frame: 6 months ]
    % of all patient-months of ART provided for the cohort that are provided within DSD models



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adults who are accessing care for HIV anywhere in the country.
Criteria

Inclusion Criteria:

  • ≥ 15 years old
  • Patients accessing care for HIV within the data collection period
  • In any HIV transmission risk group

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158895


Contacts
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Contact: Sydney B Rosen 6173582251 sbrosen@bu.edu
Contact: Lawrence Long 6173583122 lclong@bu.edu

Locations
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Malawi
All clinics Recruiting
Lilongwe, Malawi
Contact: Sophie Pascoe    +27 (10)001-7930    spascoe@heroza.org   
Sponsors and Collaborators
Boston University
Bill and Melinda Gates Foundation
University of Witwatersrand, South Africa
Clinton Health Access Initiative Inc.
Investigators
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Study Director: Sydney B Rosen Boston University School of Pubic Health
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Responsible Party: Sydney Rosen, Research Professor, Boston University
ClinicalTrials.gov Identifier: NCT04158895    
Other Study ID Numbers: H-38822
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: December 27, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sydney Rosen, Boston University:
HIV
Malawi
Differentiated service delivery
Antiretroviral therapy