Gathering Records to Evaluate Antiretroviral Treatment-South Africa

NCT ID: NCT04149782

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 7000000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2027-12-31

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 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 Department 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients enrolled in differentiated service delivery models

Routine medical record data collection

Intervention Type: OTHER

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

Routine medical record data collection

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

University of Witwatersrand, South Africa

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sydney B Rosen, MPA

Role: PRINCIPAL_INVESTIGATOR

Boston University School of Public Health, Global Health

Matthew A Fox, DSc

Role: PRINCIPAL_INVESTIGATOR

Boston University School of Public Health, Global Health

Locations

All clinics

Johannesburg, , South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

Matthew A Fox, DSc

Role: CONTACT

mfox@bu.edu

617 414 1270

Sydney B Rosen, MPA

Role: CONTACT

sbrosen@bu.edu

617 358 2251

Facility Contacts

Sophie Pascoe

Role: primary

spascoe@heroza.org

+27 (10)001-7930

References

Huber AN, Jamieson L, Fox MP, Manganye M, Malala L, Chidarikire T, Khoza N, Nichols BE, Rosen S, Pascoe S. Evaluating the impact of differentiated service delivery (DSD) on retention in care and HIV viral suppression in South Africa: A target trial emulation using routine healthcare data. PLoS Med. 2025 Aug 26;22(8):e1004489. doi: 10.1371/journal.pmed.1004489. eCollection 2025 Aug.

Reference Type: DERIVED

PMID: 40857347 (View on PubMed)

Other Identifiers

H-38815

Identifier Type: -

Identifier Source: org_study_id