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DSD Models at Zambia Sentinel Sites (SENTINEL 2) (SENTINEL2ZA)

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ClinicalTrials.gov Identifier: NCT05902572
Recruitment Status : Recruiting
First Posted : June 15, 2023
Last Update Posted : May 29, 2024
Sponsor:
Collaborators:
Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand
Clinton Health Access Initiative-Zambia
Information provided by (Responsible Party):
Boston University

Study Description
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Brief 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 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.

Alternative Models of ART Delivery: Optimizing Benefits (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, Zambia Ref. No. 2019-Sep-030), 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-Zambia 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-SA was conducted in 2021. The AMBIT 2.0 protocol will allow up to four additional annual rounds of data collection, in 2022-2025. The investigators collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Zambian healthcare facilities and their affiliated DSD models in Round 1. Round 2 (2022) and later rounds will collect the same types of data at 12 facilities in Zambia and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Zambian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets.


Condition or disease Intervention/treatment
HIV Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 8280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in Zambia (Sentinel-Zambia)
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clients using the Zambian public health system and providers employed by that system.
Criteria

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 Zambia)
  • 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 Zambia)
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05902572


Contacts
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Contact: Sydney Rosen, MPA 8572077909 sbrosen@bu.edu

Locations
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Zambia
Clinton Health Access Initiative-Zambia Recruiting
Lusaka, Zambia
Contact: Hilda Shakwelele    ‭+260 21 1267985‬    hshakwelele@clintonhealthaccess.org   
Sponsors and Collaborators
Boston University
Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand
Clinton Health Access Initiative-Zambia
Investigators
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Principal Investigator: Sydney Rosen, MPA Department of Global Health, BU School of Public Health
More Information
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Additional Information:

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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT05902572    
Other Study ID Numbers: H-41512
2021-Mar-012 ( Other Identifier: ERES-Converge IRB )
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: May 29, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Within one year of protocol closure.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
HIV
Differentiated service delivery
Zambia