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.
Mass drug administration
South Sudan
Trachoma
Journal
BMC ophthalmology
ISSN: 1471-2415
Titre abrégé: BMC Ophthalmol
Pays: England
ID NLM: 100967802
Informations de publication
Date de publication:
06 Feb 2023
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
51Subventions
Organisme : Bill and Melinda Gates Foundation
ID : Bill and Melinda Gates Foundation
Informations de copyright
© 2023. The Author(s).
Références
Lancet. 2019 May 18;393(10185):2039-2050
pubmed: 31006575
PLoS Negl Trop Dis. 2008 Sep 24;2(9):e299
pubmed: 18820746
Value Health. 2019 Sep;22(9):1026-1032
pubmed: 31511179
Lancet Infect Dis. 2019 Jan;19(1):e14-e25
pubmed: 30292480
Am J Trop Med Hyg. 2019 Mar;100(3):696-699
pubmed: 30675840
Clin Infect Dis. 2018 Apr 3;66(8):1298-1303
pubmed: 29126255
Am J Trop Med Hyg. 2011 Aug;85(2):291-4
pubmed: 21813850
Lancet. 2012 Jan 14;379(9811):143-51
pubmed: 22192488
PLoS Negl Trop Dis. 2020 May 18;14(5):e0008226
pubmed: 32421719
Trans R Soc Trop Med Hyg. 2021 Mar 6;115(3):213-221
pubmed: 33596317
PLoS Negl Trop Dis. 2011 Oct;5(10):e1362
pubmed: 22022632
Lancet. 1999 Aug 21;354(9179):630-5
pubmed: 10466664
N Engl J Med. 2018 Apr 26;378(17):1583-1592
pubmed: 29694816
PLoS Med. 2018 Aug 14;15(8):e1002633
pubmed: 30106956
Am J Trop Med Hyg. 2021 Jan;104(1):207-215
pubmed: 33200728
Clin Infect Dis. 2021 Sep 15;73(6):979-986
pubmed: 33674869
PLoS Negl Trop Dis. 2018 Nov 12;12(11):e0006950
pubmed: 30419040
Trans R Soc Trop Med Hyg. 2021 Mar 6;115(3):222-228
pubmed: 33449114
JAMA. 2008 Feb 20;299(7):778-84
pubmed: 18285589
Int Health. 2019 Nov 13;11(6):613-615
pubmed: 31329890
Lancet. 2003 Jul 19;362(9379):198-204
pubmed: 12885481
Am J Trop Med Hyg. 2021 Jan 18;104(4):1278-1289
pubmed: 33534757
Health Policy Plan. 2000 Jun;15(2):230-4
pubmed: 10837047
BMC Public Health. 2021 Apr 29;21(1):822
pubmed: 33926403
Bull World Health Organ. 1987;65(4):477-83
pubmed: 3500800
PLoS Negl Trop Dis. 2017 Jun 14;11(6):e0005658
pubmed: 28614375