HIVSENTINEL 2NCT05886530
DSD Models at South Africa Sentinel Sites
An observational study of HIV, run by Boston University at 1 site in South Africa.
Trial summary
Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service delivery" (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. 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 siteSouth Africa
- 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 South African 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
- ≥ 18 years old (18 and older considered adult for research purposes in South Africa)
- 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
- ≥ 18 years old (18 and older considered adult for research purposes in South Africa)
- 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.
South Africa1 site
Health economics and Epidemiology Research Office
Johannesburg
About this study
Official title: Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in South Africa (Sentinel-South Africa)
Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service delivery" (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. Although there is some published evidence about the health outcomes of patients in DSD models, little is known about their impacts on healthcare providers' job satisfaction, patients' quality of life, costs to providers or patients, or how DSD models affect resource allocation at the facility level.
SENTINEL is a multi-year observational study that will collect detailed data about DSD models for ART delivery and related services from 12 healthcare facilities in Malawi, 24 in South Africa, and 12 in Zambia. The first round of SENTINEL included a patient survey, provider survey, provider time-and-motion observations, and facility resource use inventory. A survey of clients testing for HIV and a supplement to the facility resource use component to describe service delivery integration will be added for the second round. The patient survey will ask up to 10 patients enrolled in each DSD model at each study site about their experiences in HIV care and in DSD models, costs incurred seeking treatment, and preferences for HIV service delivery. The provider survey will ask up to 10 providers per site about the impact of DSD models on their positions and clinics. The time-and-motion component will directly observe the time use of a sample of providers implementing DSD models. Finally, the resource utilization component will collect facility-level data about DSD model availability and enrollment and the human and other resources needed to implement them. SENTINEL is planned to include at least four approximately annual rounds of data collection between 2021 and 2025.
As national DSD programs for HIV treatment mature, it is important to understand how individual healthcare facilities are interpreting and implementing national guidelines and how healthcare workers and clients are adapting to new models of service delivery. SENTINEL will help policy makers and program managers understand the benefits and costs of differentiated service delivery and improve resource allocation going forward.
- Conditions
- HIV
- Being tested
- No intervention
- Keywords
- HIV, Differentiated service delivery, South Africa
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 posted2 Jun 2023
- Study start1 Jun 2021
- Primary completion24 Oct 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Nigeria
- 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
- NCT05886530
- Sponsor's protocol ID
- H-41402
- Other IDs
- M210241
- Acronym
- SENTINEL 2
- Status last verified
- Jan 2026
- First submitted
- 15 May 2023
- Last updated
- 8 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.
Publications
Mokhele I, Huber A, Rosen S, Kaiser JL, Lekodeba N, Ntjikelane V, Hendrickson C, Scott N, Pascoe S. Satisfaction with service delivery among HIV treatment clients enrolled in differentiated and conventional models of care in South Africa: a baseline survey. J Int AIDS Soc. 2024 Mar;27(3):e26233. doi: 10.1002/jia2.26233.
PubMed 38528370
Study at a glance
From the registry record, last updated by the sponsor on 8 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 South Africa (Sentinel-South Africa)
- ClinicalTrials.gov ID
- NCT05886530
- Acronym / sponsor ID
- SENTINEL 2 / H-41402
- Conditions
- HIV
- Keywords
- HIV, Differentiated service delivery, South Africa
- 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, Nigeria
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 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.
Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service delivery" (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. Although there is some published evidence about the health outcomes of patients in DSD models, little is known about their impacts on healthcare providers' job satisfaction, patients' quality of life, costs to providers or patients, or how DSD models affect resource allocation at the facility level.
SENTINEL is a multi-year observational study that will collect detailed data about DSD models for ART delivery and related services from 12 healthcare facilities in Malawi, 24 in South Africa, and 12 in Zambia. The first round of SENTINEL included a patient survey, provider survey, provider time-and-motion observations, and facility resource use inventory. A survey of clients testing for HIV and a supplement to the facility resource use component to describe service delivery integration will be added for the second round. The patient survey will ask up to 10 patients enrolled in each DSD model at each study site about their experiences in HIV care and in DSD models, costs incurred seeking treatment, and preferences for HIV service delivery. The provider survey will ask up to 10 providers per site about the impact of DSD models on their positions and clinics. The time-and-motion component will directly observe the time use of a sample of providers implementing DSD models. Finally, the resource utilization component will collect facility-level data about DSD model availability and enrollment and the human and other resources needed to implement them. SENTINEL is planned to include at least four approximately annual rounds of data collection between 2021 and 2025.
As national DSD programs for HIV treatment mature, it is important to understand how individual healthcare facilities are interpreting and implementing national guidelines and how healthcare workers and clients are adapting to new models of service delivery. SENTINEL will help policy makers and program managers understand the benefits and costs of differentiated service delivery and improve resource allocation going forward.
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 South African 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 8 Jan 2026.
- Derived from this study: PubMed 38528370Mokhele I, Huber A, Rosen S, Kaiser JL, Lekodeba N, Ntjikelane V, Hendrickson C, Scott N, Pascoe S. Satisfaction with service delivery among HIV treatment clients enrolled in differentiated and conventional models of care in South Africa: a baseline survey. J Int AIDS Soc. 2024 Mar;27(3):e26233. doi: 10.1002/jia2.26233.
- 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 South Africa.
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 8 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 South Africa. 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?
On the ClinicalTrials.gov record for NCT05886530, which also lists 1 linked publication.
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 8 Jan 2026.