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NCT Number: NCT05886530

DSD Models at South Africa Sentinel Sites

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health economics and Epidemiology Research Office

Johannesburg, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the time and motion study are:

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

Inclusion criteria

for provider interviews are:

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
Employed in current role at the study site for at least six months
Provides written informed consent to participate.

Inclusion criteria

for the patient survey are:

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.

Inclusion criteria

for the testing survey are:

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.

Exclusion criteria

for the time and motion study are:

● None.

Exclusion criteria

for provider interviews are:

● None.

Exclusion criteria

for the patient survey are:

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.

Exclusion criteria

for the testing survey are:

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.

Treatment and study plan

No intervention

Other

Observational data collection only.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

Clinton Health Access Initiative, Nigeria
Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand

Registry information

Official study title

Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in South Africa (Sentinel-South Africa)

Acronym: SENTINEL 2

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2027
First posted: Jun 2, 2023
Registry last updated: Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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