DSD Models at South Africa Sentinel Sites

NCT05886530 | Active Not Recruiting

• 2 other identifiers: H-41402M210241
• Study Type: observational
• Target: 15,520
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

HIV; Differentiated service delivery; South Africa

Outcome Measures

Primary Outcomes (1)

• 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

  12 months after enrollment

Study Arms (4)

HIV treatment survey participants

HIV treatment patients eligible to be enrolled in the patient survey

Other: No intervention

Provider survey participants

HIV treatment providers eligible to be enrolled in the provider survey

Other: No intervention

Time and motion observation participants

HIV treatment providers eligible to be enrolled in the time and motion observation study

Other: No intervention

HIV testing survey participants

Individuals presenting for HIV testing eligible to be enrolled in the HIV testing survey

Other: No intervention

Interventions

No intervention OTHER

Observational data collection only.

HIV testing survey participants; HIV treatment survey participants; Provider survey participants; Time and motion observation participants

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clients using the South African public health system and providers employed by that system.

You may qualify if:

• 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
• 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.

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• Boston University: lead
• Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand: collaborator
• Clinton Health Access Initiative, Nigeria: collaborator

Study Sites (1)

Health economics and Epidemiology Research Office

Johannesburg, South Africa

Location

Related Publications (1)

• 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.

  PMID: 38528370 DERIVED

Related Links

• Project website

Study Officials

• Sydney Rosen, MPA

  Department of Global Health, BU School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 2, 2023
• Study Start: June 1, 2021
• Primary Completion: October 24, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within one year of protocol closure.

Locations

ZA (1)