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N/A N=27,473 Randomized Single-blind Diagnostic

Identification of TT Cases by Community Treatment Assistants: An Assessment

Trichiasis

Enrolled (actual)
27,473
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: TT Cases Screened Positive by CTA's and Confirmed by Graders — 9; 50 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
TT Training Program and TT Screening Card (Other)
Age
Pediatric, Adult, Older Adult · 15+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
TT Cases Screened Positive by CTA's and Confirmed by Graders
9; 50
SECONDARY
Sensitivity of TT Screening Methods
5.7; 31.2
SECONDARY
Specificity of TT Screening Methods
99.7; 98.0
SECONDARY
Positive Predictive Values of TT Screening Methods
28.1; 15.8
SECONDARY
Negative Predictive Values of TT Screening Methods
98.0; 2.2

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.

Eligibility Criteria

Inclusion Criteria

  • All persons in the study and control communities are eligible for the MDA.
  • Adults aged 15 and over will be eligible for the survey and re-assessment.
  • Those who are screened positive in the re-assessment will be eligible for treatment at the surgery camp.
  • Those who are screened positive for TT initially but refuse the definitive re-screening will still be offered surgery but told they may not have TT and will be re-screened by the surgeon.

Exclusion Criteria

  • none
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01783743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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