NCT04158895 Gathering Records to Evaluate Antiretroviral Treatment-Malawi ( GREAT )
| NCT ID | NCT04158895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University |
| Condition | HIV |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000,000 participants |
| Start Date | 2019-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000,000 participants in total. It began in 2019-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Sydney B Rosen
STUDY DIRECTOR
Boston University School of Pubic Health
Frequently Asked Questions
Who can join the NCT04158895 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04158895 currently recruiting?
Yes, NCT04158895 is actively recruiting participants. Contact the research team at sbrosen@bu.edu for enrollment information.
Where is the NCT04158895 trial being conducted?
This trial is being conducted at Lilongwe, Malawi.
Who is sponsoring the NCT04158895 clinical trial?
NCT04158895 is sponsored by Boston University. The principal investigator is Sydney B Rosen at Boston University School of Pubic Health. The trial plans to enroll 1,000,000 participants.
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