Clinical trial NCT01783743: Identification of TT Cases by Community Treatment Assistants: An Assessment
Official title: Identification of TT Cases by Community Treatment Assistants: An Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichiasis
Keywords: Trichiasis
Trachoma
Mass treatment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Lions Club International Foundation
First posted: 2013-02-05
Enrollment: 27473
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: TT Cases Screened Positive by CTA's and Confirmed by Graders
timeFrame: 10 months
Secondary outcomes:
measure: Sensitivity of TT Screening Methods
timeFrame: 10 months
measure: Specificity of TT Screening Methods
timeFrame: 10 months
measure: Positive Predictive Values of TT Screening Methods
timeFrame: 10 months
measure: Negative Predictive Values of TT Screening Methods
timeFrame: 10 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sheila K West, PhD
role: PRINCIPAL_INVESTIGATOR
References: