Cost and community acceptability of enhanced antibiotic distribution approaches for trachoma in the Republic of South Sudan: enhancing the A in SAFE (ETAS) study protocol.


Journal

BMC ophthalmology
ISSN: 1471-2415
Titre abrégé: BMC Ophthalmol
Pays: England
ID NLM: 100967802

Informations de publication

Date de publication:
06 Feb 2023
Historique:
received: 18 04 2022
accepted: 13 01 2023
entrez: 7 2 2023
pubmed: 8 2 2023
medline: 9 2 2023
Statut: epublish

Résumé

The World Health Organization targeted trachoma for global elimination as a public health problem by 2030. Reaching elimination thresholds by the year 2030 in the Republic of South Sudan will be a considerable challenge, as the country currently has many counties considered hyper-endemic (> 30% trachomatous inflammation-follicular [TF]) that have yet to receive interventions. Evidence from randomized trials, modeling, and population-based surveys suggests that enhancements may be needed to the standard-of-care annual mass drug administration (MDA) to reach elimination thresholds in a timely manner within highly endemic areas. We describe a protocol for a study to determine the cost and community acceptability of enhanced antibiotic strategies for trachoma in South Sudan. The Enhancing the A in SAFE (ETAS) study is a community randomized intervention costing and community acceptability study. Following a population-based trachoma prevalence survey in 1 county, 30 communities will be randomized 1:1 to receive 1 of 2 enhanced MDA interventions, with the remaining communities receiving standard-of-care annual MDA. The first intervention strategy will consist of a community-wide MDA followed by 2 rounds of targeted treatment to children ages 6 months to 9 years, 2 weeks and 4 weeks after the community MDA. The second strategy will consist of a community-wide biannual MDA approximately 6 to 8 months apart. The costing analysis will use a payer perspective and identify the total cost of the enhanced interventions and annual MDA. Community acceptability will be assessed through MDA coverage monitoring and mixed-methods research involving community stakeholders. A second trachoma-specific survey will be conducted 12 months following the original survey. ETAS has received ethical clearance and is expected to be conducted between 2022 and 2023. Results will be shared through subsequent manuscripts. The study's results will provide information to trachoma programs on whether enhanced interventions are affordable and acceptable to communities. These results will further help in the design of future trachoma-specific antibiotic efficacy trials. Enhanced MDA approaches could help countries recover from delays caused by conflict or humanitarian emergencies and could also assist countries such as South Sudan in reaching trachoma elimination as a public health problem by 2030. This trial was registered on December 1

Sections du résumé

BACKGROUND BACKGROUND
The World Health Organization targeted trachoma for global elimination as a public health problem by 2030. Reaching elimination thresholds by the year 2030 in the Republic of South Sudan will be a considerable challenge, as the country currently has many counties considered hyper-endemic (> 30% trachomatous inflammation-follicular [TF]) that have yet to receive interventions. Evidence from randomized trials, modeling, and population-based surveys suggests that enhancements may be needed to the standard-of-care annual mass drug administration (MDA) to reach elimination thresholds in a timely manner within highly endemic areas. We describe a protocol for a study to determine the cost and community acceptability of enhanced antibiotic strategies for trachoma in South Sudan.
METHODS METHODS
The Enhancing the A in SAFE (ETAS) study is a community randomized intervention costing and community acceptability study. Following a population-based trachoma prevalence survey in 1 county, 30 communities will be randomized 1:1 to receive 1 of 2 enhanced MDA interventions, with the remaining communities receiving standard-of-care annual MDA. The first intervention strategy will consist of a community-wide MDA followed by 2 rounds of targeted treatment to children ages 6 months to 9 years, 2 weeks and 4 weeks after the community MDA. The second strategy will consist of a community-wide biannual MDA approximately 6 to 8 months apart. The costing analysis will use a payer perspective and identify the total cost of the enhanced interventions and annual MDA. Community acceptability will be assessed through MDA coverage monitoring and mixed-methods research involving community stakeholders. A second trachoma-specific survey will be conducted 12 months following the original survey.
DISCUSSION CONCLUSIONS
ETAS has received ethical clearance and is expected to be conducted between 2022 and 2023. Results will be shared through subsequent manuscripts. The study's results will provide information to trachoma programs on whether enhanced interventions are affordable and acceptable to communities. These results will further help in the design of future trachoma-specific antibiotic efficacy trials. Enhanced MDA approaches could help countries recover from delays caused by conflict or humanitarian emergencies and could also assist countries such as South Sudan in reaching trachoma elimination as a public health problem by 2030.
TRIAL REGISTRATION BACKGROUND
This trial was registered on December 1

Identifiants

pubmed: 36747194
doi: 10.1186/s12886-023-02783-x
pii: 10.1186/s12886-023-02783-x
pmc: PMC9900535
doi:

Substances chimiques

Anti-Bacterial Agents 0

Banques de données

ClinicalTrials.gov
['NCT05634759']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

51

Subventions

Organisme : Bill and Melinda Gates Foundation
ID : Bill and Melinda Gates Foundation

Informations de copyright

© 2023. The Author(s).

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Auteurs

Angelia M Sanders (AM)

The Carter Center, Atlanta, GA, USA. angelia.sanders@cartercenter.org.

Samuel Makoy (S)

Ministry of Health, Juba, Republic of South Sudan.

Andrew R Deathe (AR)

The Carter Center, Atlanta, GA, USA.

Stephen Ohidor (S)

The Carter Center, Juba, Republic of South Sudan.

Timothy C Jesudason (TC)

Partners in Global Health Ltd, Dereham, UK.

Andrew W Nute (AW)

The Carter Center, Atlanta, GA, USA.

Patrick Odongi (P)

The Carter Center, Juba, Republic of South Sudan.

Lochebe Boniface (L)

The Carter Center, Juba, Republic of South Sudan.

Stella Abuba (S)

The Carter Center, Juba, Republic of South Sudan.

Alexis S Delahaut (AS)

The Carter Center, Juba, Republic of South Sudan.

Wilson Sebit (W)

Ministry of Health, Juba, Republic of South Sudan.

James Niquette (J)

The Carter Center, Juba, Republic of South Sudan.

E Kelly Callahan (EK)

The Carter Center, Atlanta, GA, USA.

Damian G Walker (DG)

Independent Contractor, Arlington, VA, USA.

Scott D Nash (SD)

The Carter Center, Atlanta, GA, USA.

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Classifications MeSH