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

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ClinicalTrials.gov Identifier: NCT01783743
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : February 23, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Lions Club International Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Trichiasis
Intervention Other: TT Training Program and TT Screening Card
Enrollment 27473
Recruitment Details Community randomized trial was conducted in 36 communities during MDA .Community served as unit of randomization & enrolled villages were randomly allocated on 1:1 basis to either intervention (n=18) or usual care (n=18) arms.Total MDA eligible population in control arm was 13509 individuals and in the intervention arm was 13964 individuals.
Pre-assignment Details Community Treatment Assistants(CTAs) in intervention arm received an additional half-day training and TT screening card in addition to training received by CTAs in usual care arm. All MDA participants 15 years and older were screened for TT.Senior grader re-screened all TT cases identified by CTAs along with a selected random sample in both arms.
Arm/Group Title Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Hide Arm/Group Description Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

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.

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.

Period Title: Screening of Subjects by CTA During MDA
Number of participants Number of units (communities) Number of participants Number of units (communities)
Started 13509 18 13964 18
Completed 10082 18 9525 18
Not Completed 3427 0 4439 0
Reason Not Completed
Absent at MDA             3427                         4439            
Period Title: Rescreening of Subjects by Senior Grader
Number of participants Number of units (communities) Number of participants Number of units (communities)
Started 13509 18 13964 18
TT Positive Cases Screened by CTA 46 18 409 18
Random Sample From Non TT Cases by CTA 1721 18 1786 18
Random Sample From Subject Absent at MDA 846 18 849 18
Completed 2613 18 3044 18
Not Completed 10896 0 10920 0
Reason Not Completed
Lost to Follow-up             591                         684            
Not part of the random sample selected             10305                         10236            
Arm/Group Title Control (Usual Assessment) Intervention (Novel TT Screening Tool) Total
Hide Arm/Group Description Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 13509 13964 27473
Overall Number of Units Analyzed
Type of Units Analyzed: Community
18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Inter-Quartile Range)
Unit of measure:  Participants
Number Analyzed 13509 participants 13964 participants 27473 participants
15-39 years
494
(327 to 682)
482
(398 to 644)
488
(364 to 663)
40-59 years
168
(97 to 203)
152
(119 to 206)
160
(108 to 205)
60 and older
81
(54 to 107)
83
(67 to 108)
82
(61 to 108)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13509 participants 13964 participants 27473 participants
Female
7160
  53.0%
7401
  53.0%
14561
  53.0%
Male
6349
  47.0%
6563
  47.0%
12912
  47.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Tanzania Number Analyzed 13509 participants 13964 participants 27473 participants
13509
 100.0%
13964
 100.0%
27473
 100.0%
1.Primary Outcome
Title TT Cases Screened Positive by CTA's and Confirmed by Graders
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Hide Arm/Group Description:
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

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.

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.

Overall Number of Participants Analyzed 32 316
Measure Type: Count of Participants
Unit of Measure: Participants
9
  28.1%
50
  15.8%
2.Secondary Outcome
Title Sensitivity of TT Screening Methods
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Hide Arm/Group Description:
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

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.

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.

Overall Number of Participants Analyzed 46 409
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true positives
5.7
(2.6 to 8.6)
31.2
(24.9 to 37.6)
3.Secondary Outcome
Title Specificity of TT Screening Methods
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Hide Arm/Group Description:
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

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.

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.

Overall Number of Participants Analyzed 10036 9116
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true negatives
99.7
(99.6 to 99.8)
98.0
(97.6 to 98.2)
4.Secondary Outcome
Title Positive Predictive Values of TT Screening Methods
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Hide Arm/Group Description:
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

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.

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.

Overall Number of Participants Analyzed 46 409
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true positives
28.1
(15.1 to 41.1)
15.8
(12.3 to 19.4)
5.Secondary Outcome
Title Negative Predictive Values of TT Screening Methods
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Hide Arm/Group Description:
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

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.

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.

Overall Number of Participants Analyzed 10036 9116
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true negatives
98.0
(97.6 to 98.2)
2.2
(2.0 to 2.5)
Time Frame 10 months (Between January 2013 to November 2013)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Hide Arm/Group Description Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

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.

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.

All-Cause Mortality
Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13509 (0.00%)   0/13964 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control (Usual Assessment) Intervention (Novel TT Screening Tool)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13509 (0.00%)   0/13964 (0.00%) 
  1. While use of CTAs in TT screening during MDA offers clear advantages, this approach is limited to areas that merit MDA.
  2. Attrition of CTAs may also prove to be a limitation for this screening approach.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sheila K West
Organization: Johns Hopkins University
Phone: 410 955 2606
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01783743     History of Changes
Other Study ID Numbers: NA_00043444
First Submitted: January 30, 2013
First Posted: February 5, 2013
Results First Submitted: April 26, 2017
Results First Posted: February 23, 2018
Last Update Posted: March 21, 2018