Identification of TT Cases by Community Treatment Assistants: An Assessment (SIMBA)
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 complain, 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.
Thirty-six villages, for which 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 sets of villages the CTAs will keep records of all cases they have screened as positive for TT.
A Master TT grader will grade all screened cases of TT to determine the rate of true positivity. 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. 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Identification of TT Cases by Community Treatment Assistants: An Assessment|
- TT Cases Detected [ Time Frame: 11 months ] [ Designated as safety issue: No ]Number of TT cases detected in intervention versus control arms (adjusted for population size) through screening
- Sensitivity and Specificity of TT Screening Methods [ Time Frame: 11 months ] [ Designated as safety issue: No ]Sensitivity and specificity of the different TT screening methods compared to "true" assessment of cases and controls
- Positive and Negative Predictive Values of TT Screening Methods [ Time Frame: 11 months ] [ Designated as safety issue: No ]Positive and Negative Predictive Values of the different screening methods compared to "true" assessment of cases and controls
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.
Other: TT Training Program and Recognition Card
The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery.
No Intervention: Usual Assessment
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783743
|Contact: Sheila K West, PhDfirstname.lastname@example.org|
|Contact: Gregory S Greene, BSemail@example.com|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Sheila K West, PhD 410-955-2606 firstname.lastname@example.org|
|Principal Investigator: Sheila K West, PhD|
|Principal Investigator:||Sheila K West, PhD||Johns Hopkins University|