Clinical trial NCT04158895: Gathering Records to Evaluate Antiretroviral Treatment-Malawi ( GREAT )
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Keywords: HIV
Malawi
Differentiated service delivery
Antiretroviral therapy
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: University of Witwatersrand, South Africa
name: Clinton Health Access Initiative Inc.
First posted: 2019-11-12
Enrollment: 1000000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults who are accessing care for HIV anywhere in the country.

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.


Eligibility 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

Primary outcomes:
measure: Patient-months enrolled in any DSD model
timeFrame: 12 months
measure: Patient-months enrolled in any DSD model
timeFrame: 24 months
measure: Patient-months enrolled in any DSD model
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: All clinics
Study officials:
affiliation: Boston University School of Pubic Health
name: Sydney B Rosen
role: STUDY_DIRECTOR
References: