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Identification of TT Cases by Community Treatment Assistants: An Assessment (SIMBA)

Primary Purpose

Trichiasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TT Training Program and TT Screening Card
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Trichiasis focused on measuring Trichiasis, Trachoma, Mass treatment

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Usual Assessment arm

Arm Description

Community treatment assistants (CTA ) will receive usual training, including the basic background of trachoma/trichiasis recognition, drug administration, and azithromycin dosing. In addition to the usual training, these CTA's will also receive an additional modest half day training for TT case recognition which is called the TT training program and TT Screening Card to help them identify TT cases and refer them for surgery.

Community treatment assistants will receive only usual training, including the basic background of trachoma/trichiasis recognition, drug administration, and azithromycin dosing.

Outcomes

Primary Outcome Measures

TT Cases Screened Positive by CTA's and Confirmed by Graders
All the TT cases detected in control versus intervention arms (adjusted for population size) through screening were verified by graders. Grader re-graded all these cases except for the cases lost to follow-up.

Secondary Outcome Measures

Sensitivity of TT Screening Methods
Sensitivity of different TT screening methods compared to "true" assessment of cases and controls using the extrapolated values from the follow-up survey. Formula used: True positives/(true positives +false negative)
Specificity of TT Screening Methods
Specificity of different TT screening methods compared to "true" assessment of cases and controls using the extrapolated values from the follow-up survey. Formula used: True negatives/(true negatives +false positive)
Positive Predictive Values of TT Screening Methods
Positive Predictive Values (PPV) of the different screening methods compared to "true" assessment of cases and controls. It was calculated by using extrapolated values. The formula used: True positives /total participants at initial screening screened as positive by CTA's.
Negative Predictive Values of TT Screening Methods
Negative Predictive Values (NPV) of the different screening methods compared to "true" assessment of cases and controls. It was calculated by using extrapolated values. Formula used : True Negatives /total participants at initial screening,screened as negative by CTA's

Full Information

First Posted
January 30, 2013
Last Updated
February 22, 2018
Sponsor
Johns Hopkins University
Collaborators
Lions Club International Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01783743
Brief Title
Identification of TT Cases by Community Treatment Assistants: An Assessment
Acronym
SIMBA
Official Title
Identification of TT Cases by Community Treatment Assistants: An Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Lions Club International Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichiasis
Keywords
Trichiasis, Trachoma, Mass treatment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27473 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Community treatment assistants (CTA ) will receive usual training, including the basic background of trachoma/trichiasis recognition, drug administration, and azithromycin dosing. In addition to the usual training, these CTA's will also receive an additional modest half day training for TT case recognition which is called the TT training program and TT Screening Card to help them identify TT cases and refer them for surgery.
Arm Title
Usual Assessment arm
Arm Type
No Intervention
Arm Description
Community treatment assistants will receive only usual training, including the basic background of trachoma/trichiasis recognition, drug administration, and azithromycin dosing.
Intervention Type
Other
Intervention Name(s)
TT Training Program and TT Screening Card
Intervention Description
The intervention is an additional half day training program on trichiasis recognition (TT Training Program) and a TT Screening card to assist community treatment assistants in recognizing TT cases and referring them to surgery.
Primary Outcome Measure Information:
Title
TT Cases Screened Positive by CTA's and Confirmed by Graders
Description
All the TT cases detected in control versus intervention arms (adjusted for population size) through screening were verified by graders. Grader re-graded all these cases except for the cases lost to follow-up.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Sensitivity of TT Screening Methods
Description
Sensitivity of different TT screening methods compared to "true" assessment of cases and controls using the extrapolated values from the follow-up survey. Formula used: True positives/(true positives +false negative)
Time Frame
10 months
Title
Specificity of TT Screening Methods
Description
Specificity of different TT screening methods compared to "true" assessment of cases and controls using the extrapolated values from the follow-up survey. Formula used: True negatives/(true negatives +false positive)
Time Frame
10 months
Title
Positive Predictive Values of TT Screening Methods
Description
Positive Predictive Values (PPV) of the different screening methods compared to "true" assessment of cases and controls. It was calculated by using extrapolated values. The formula used: True positives /total participants at initial screening screened as positive by CTA's.
Time Frame
10 months
Title
Negative Predictive Values of TT Screening Methods
Description
Negative Predictive Values (NPV) of the different screening methods compared to "true" assessment of cases and controls. It was calculated by using extrapolated values. Formula used : True Negatives /total participants at initial screening,screened as negative by CTA's
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila K West, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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Identification of TT Cases by Community Treatment Assistants: An Assessment

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