Gathering Records to Evaluate Antiretroviral Treatment-Malawi ( GREAT )

NCT04158895 | Recruiting

• 1 other identifier: H-38822
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Malawi; Differentiated service delivery; Antiretroviral therapy

Outcome Measures

Primary Outcomes (3)

• Patient-months enrolled in any DSD model

  % of all patient-months of ART provided for the cohort that are provided within DSD models

  12 months

• Patient-months enrolled in any DSD model

  % of all patient-months of ART provided for the cohort that are provided within DSD models

  24 months

• Patient-months enrolled in any DSD model

  % of all patient-months of ART provided for the cohort that are provided within DSD models

  6 months

Study Arms (2)

Patients enrolled in differentiated service delivery models

Other: Routine medical record data collection

Patients not enrolled in DSD models

Other: Routine medical record data collection

Interventions

Routine medical record data collection OTHER

The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.

Patients enrolled in differentiated service delivery models; Patients not enrolled in DSD models

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults who are accessing care for HIV anywhere in the country.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston University: lead
• Bill and Melinda Gates Foundation: collaborator
• University of Witwatersrand, South Africa: collaborator
• Clinton Health Access Initiative Inc.: collaborator

Study Sites (1)

All clinics

Lilongwe, Malawi

RECRUITING

Study Officials

• Sydney B Rosen

  Boston University School of Pubic Health

  STUDY DIRECTOR

Central Study Contacts

Sydney B Rosen

CONTACT

6173582251; sbrosen@bu.edu

Lawrence Long

CONTACT

6173583122; lclong@bu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: December 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)