DSD Models at South Africa Sentinel Sites (SENTINEL 2)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 15520

Contacts and Locations

• Study Contact: Name: Sydney Rosen, MPA; Phone Number: 8572077909; Email: sbrosen@bu.edu

Study Locations

• South Africa
  • Johannesburg, South Africa
    • Recruiting
    • Health Economics and Epidemiology Research Office
    • Contact: Amy Huber; Phone Number: 27 74 143 3515; Email: ahuber@heroza.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV treatment survey participants; HIV treatment patients eligible to be enrolled in the patient survey	Other: No intervention; Observational data collection only.
Provider survey participants; HIV treatment providers eligible to be enrolled in the provider survey	Other: No intervention; Observational data collection only.
Time and motion observation participants; HIV treatment providers eligible to be enrolled in the time and motion observation study	Other: No intervention; Observational data collection only.
HIV testing survey participants; Individuals presenting for HIV testing eligible to be enrolled in the HIV testing survey	Other: No intervention; Observational data collection only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Clinton Health Access Initiative, Nigeria; Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand
• Investigators: Principal Investigator: Sydney Rosen, MPA, Department of Global Health, BU School of Public Health

Publications and helpful links

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Estimated): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HIV; South Africa; Differentiated service delivery
• Other Study ID Numbers: H-41402; M210241 (Other Identifier: University of the Witwatersrand)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Within one year of protocol closure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No