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Clinical Trial Summary

To achieve the goal of trachoma control as mandated by the World Health Organization, countries must reduce the backlog of trichiasis surgery cases to less than 1/1,000 of their population. However, these cases reside in rural villages in trachoma endemic districts, and finding them to offer services is a challenge. Community Treatment Assistants (CTAs) are village residents who are trained to offer Mass Drug Administration (MDA) to their communities and hence are in contact with most residents. A training guide and tool for screening for trachomatous trichiasis (TT) will be developed to train CTAs in rural Tanzania to identify cases in their communities and refer them to surgery. Compared to the current process by which CTAs passively screen for TT if cases complaint, investigators hypothesize that the trained CTAs will identify twice the usual number of TT surgery cases during ongoing community antibiotic administrations for trachoma and will also miss fewer cases. If this simple system is effective, it can be implemented widely to screen communities for cases of TT.

Residents from thirty-six villages holding MDA, for whom a complete census is available, will be randomized on a 1:1 basis to intervention (where the CTAs receive the enhanced training from the enhanced training team) and usual assessment (where the CTAs receive the usual instructions from the regular MDA team). In both arms, the CTAs will keep records of all cases they have screened as positive for TT amongst the residents.

A Master TT grader will grade all screened cases of TT to determine the rate of true positivity in both arms.In addition, he will examine a random sample of residents who are screened as negative to detect potentially missed cases and estimate the total burden of trichiasis cases in both arms as well.The assessments of the Master TT grader will serve as the gold standard for calculations of sensitivity, specificity, and positive and negative predictive values of the enhanced training versus usual assessment methods.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01783743
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase N/A
Start date February 2013
Completion date December 2013

See also
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Active, not recruiting NCT04149210 - FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial Phase 3
Withdrawn NCT03947723 - Histology Evaluation of Radiofrequency Ablation N/A
Completed NCT00347776 - Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia Phase 4
Completed NCT03100747 - Maximizing Trichiasis Surgery Success N/A
Completed NCT03886519 - Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial N/A