HIVGREATNCT04158895
Gathering Records to Evaluate Antiretroviral Treatment-Malawi ( GREAT )
An observational study of HIV, run by Boston University at 1 site in Malawi.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Routine medical record data collection
- How many people
- 1,000,000 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Dec 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adults who are accessing care for HIV anywhere in the country.
Who may be able to join
- ≥ 15 years old
- Patients accessing care for HIV within the data collection period
- In any HIV transmission risk group
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site, 1 recruiting
- Recruiting
All clinics
Lilongwe
Sophie Pascoe, +27 (10)001-7930, spascoe@heroza.org
About this study
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)
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
- Being tested
- Routine medical record data collection
- Keywords
- HIV, Malawi, Differentiated service delivery, Antiretroviral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine medical record data collectionOther
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled in differentiated service delivery models | Not described Receives: Other: Routine medical record data collection | |
| Patients not enrolled in DSD models | Not described Receives: Other: Routine medical record data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-months enrolled in any DSD model
% of all patient-months of ART provided for the cohort that are provided within DSD models
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Dec 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa, Clinton Health Access Initiative Inc.
- Responsible party
- Sponsor
- Investigators
- Sydney B Rosen, Study director, Boston University School of Pubic Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158895
- Sponsor's protocol ID
- H-38822
- Acronym
- GREAT
- Status last verified
- Nov 2025
- First submitted
- 7 Nov 2019
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04158895
- Acronym / sponsor ID
- GREAT / H-38822
- Conditions
- HIV
- Keywords
- HIV, Malawi, Differentiated service delivery, Antiretroviral therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa, Clinton Health Access Initiative Inc.
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adults who are accessing care for HIV anywhere in the country.
Key inclusion criteria (3 listed)
- ≥ 15 years old
- Patients accessing care for HIV within the data collection period
- In any HIV transmission risk group
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine medical record data collectionThe study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts. | Other | Patients enrolled in differentiated service delivery models, Patients not enrolled in DSD models |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sydney B Rosen study director
Boston University School of Pubic Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Boston University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sydney B Rosen (6173582251, sbrosen@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-months enrolled in any DSD model (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.