HIVSENTINEL2MWNCT05901727
DSD Models at Malawi Sentinel Sites (SENTINEL 2-Malawi)
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, many countries are piloting 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV
- How many people
- 15,520 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Jun 2021to 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: Clients using the Malawian public health system and providers employed by that system.
Who may be able to join
- Patient-facing or patient-supporting service provider at the study site (patient-supporting providers include data clerks, pharmacists, etc.)
- Directly or indirectly involved in the site's implementation of ART and DSD models
- Employed in current role at the study site for at least six months
- Provides written informed consent to participate
- Direct or indirect service provider at the study site (indirect providers include supervisors, technical advisors, etc.)
- Directly or indirectly involved in the site's implementation of ART and DSD models
Show all 15Show fewer
- Employed in current role at the study site for at least six months
- Provides written informed consent to participate.
- Living with HIV and on ART for at least six months at the study site
- ≥ 16 years old (16 and older considered adult for research purposes in Malawi)
- Enrolled in a specified model of care (including conventional care) up to the target number of participants for that model and have received at least one medication refill under this model
- Provide written informed consent to participate.
- Undergoing HIV testing at the study site or other testing site within the catchment area
- ≥ 16 years old (16 and older considered adult for research purposes in Malawi)
- Provide written informed consent to participate.
Who cannot join
- ● None.
- ● None.
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
- Unwilling to take the time required to complete the questionnaire on the day of consent.
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
- Unwilling to take the time required to complete the questionnaire on the day of consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in Malawi (Sentinel-Malawi)
To achieve global goals for the treatment of HIV, many countries are piloting 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, the investigators have little evidence on progress and challenges at the facility level-the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients.
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. The first AMBIT protocol, "Gathering Records to Evaluate Antiretroviral Treatment" (GREAT, Malawi NHRC 2376), collects and analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD models on patients' clinical outcomes and to evaluate uptake of DSD models at scale.
The Sentinel-Malawi study, the second AMBIT protocol, is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-Malawi was conducted in 2021. The investigators are now amending the protocol to allow up to two additional annual rounds of data collection, in 2022-2023. The investigators collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Malawian healthcare facilities and their affiliated DSD models in Round 1. Round 2 and 3 will collect the same types of data at 12 facilities in Malawi and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Malawian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets.
- Conditions
- HIV
- Being tested
- No intervention
- Keywords
- HIV, Differentiated service delivery, Malawi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational data collection only.
| Study group | Role | What they receive |
|---|---|---|
| HIV treatment survey participants | HIV treatment patients eligible to be enrolled in the patient survey Receives: Other: No intervention | |
| Provider survey participants | HIV treatment providers eligible to be enrolled in the provider survey Receives: Other: No intervention | |
| Time and motion observation participants | HIV treatment providers eligible to be enrolled in the time and motion observation study Receives: Other: No intervention | |
| HIV testing survey participants | Individuals presenting for HIV testing eligible to be enrolled in the HIV testing survey Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient survey participants with HIV viral suppression ≤400 copies/ml at most recent test
Viral suppression among ART patients enrolled and not enrolled in differentiated service delivery models
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Jun 2021
- Primary completion14 Dec 2024
- Study completionDec 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
- 15,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand, Clinton Health Access Initiative-Malawi
- Responsible party
- Sponsor
- Investigators
- Sydney Rosen, MPA, Principal investigator, Department of Global Health, BU School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901727
- Sponsor's protocol ID
- H-41345
- Other IDs
- 21/03267
- Acronym
- SENTINEL2MW
- Status last verified
- Jan 2026
- First submitted
- 5 Jun 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that are collected by the study will be made available after protocol closure. Data that are owned by others (e.g. the National Department of Health) cannot be shared by the authors.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in Malawi (Sentinel-Malawi)
- ClinicalTrials.gov ID
- NCT05901727
- Acronym / sponsor ID
- SENTINEL2MW / H-41345
- Conditions
- HIV
- Keywords
- HIV, Differentiated service delivery, Malawi
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,520 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand, Clinton Health Access Initiative-Malawi
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jun 2023 (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, many countries are piloting 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, the investigators have little evidence on progress and challenges at the facility level-the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients.
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. The first AMBIT protocol, "Gathering Records to Evaluate Antiretroviral Treatment" (GREAT, Malawi NHRC 2376), collects and analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD models on patients' clinical outcomes and to evaluate uptake of DSD models at scale.
The Sentinel-Malawi study, the second AMBIT protocol, is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-Malawi was conducted in 2021. The investigators are now amending the protocol to allow up to two additional annual rounds of data collection, in 2022-2023. The investigators collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Malawian healthcare facilities and their affiliated DSD models in Round 1. Round 2 and 3 will collect the same types of data at 12 facilities in Malawi and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Malawian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV treatment survey participants | – | Other: No interventionHIV treatment patients eligible to be enrolled in the patient survey |
| Provider survey participants | – | Other: No interventionHIV treatment providers eligible to be enrolled in the provider survey |
| Time and motion observation participants | – | Other: No interventionHIV treatment providers eligible to be enrolled in the time and motion observation study |
| HIV testing survey participants | – | Other: No interventionIndividuals presenting for HIV testing eligible to be enrolled in the HIV testing survey |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clients using the Malawian public health system and providers employed by that system.
Key inclusion criteria (15 listed)
- Patient-facing or patient-supporting service provider at the study site (patient-supporting providers include data clerks, pharmacists, etc.)
- Directly or indirectly involved in the site's implementation of ART and DSD models
- Employed in current role at the study site for at least six months
- Provides written informed consent to participate
- Direct or indirect service provider at the study site (indirect providers include supervisors, technical advisors, etc.)
Key exclusion criteria (8 listed)
- ● None.
- ● None.
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
- Unwilling to take the time required to complete the questionnaire on the day of consent.
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 |
|---|---|---|
| No interventionObservational data collection only. | Other | HIV testing survey participants, HIV treatment survey participants, Provider survey participants, Time and motion observation participants |
Primary outcome
Proportion of patient survey participants with HIV viral suppression ≤400 copies/ml at most recent test
Time frame: 12 months after enrollment
Viral suppression among ART patients enrolled and not enrolled in differentiated service delivery 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 27 Jan 2026.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data that are collected by the study will be made available after protocol closure. Data that are owned by others (e.g. the National Department of Health) cannot be shared by the authors.
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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. This study is not recruiting at the moment.
Sydney Rosen, MPA principal investigator
Department of Global Health, BU School of Public 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 15 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patient survey participants with HIV viral suppression ≤400 copies/ml at most recent test (time frame: 12 months after enrollment). 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 27 Jan 2026.