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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (communities)

Reporting Groups
  Description
Control (Usual Assessment) Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
Intervention (Novel TT Screening Tool)

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.


Participant Flow for 2 periods

Period 1:   Screening of Subjects by CTA During MDA
    Control (Usual Assessment)   Intervention (Novel TT Screening Tool)
Participants Units (communities) Participants Units (communities)
STARTED   13509   18   13964   18 
COMPLETED   10082   18   9525   18 
NOT COMPLETED   3427      4439    
Absent at MDA                3427                                4439                 

Period 2:   Rescreening of Subjects by Senior Grader
    Control (Usual Assessment)   Intervention (Novel TT Screening Tool)
Participants Units (communities) Participants 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      10920    
Lost to Follow-up                591                                684                 
Not part of the random sample selected                10305                                10236                 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control (Usual Assessment) Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
Intervention (Novel TT Screening Tool)

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 Total of all reporting groups

Baseline Measures
   Control (Usual Assessment)   Intervention (Novel TT Screening Tool)   Total 
Overall Participants Analyzed 
[Units: Participants]
 13509   13964   27473 
Overall Units Analyzed (Community) 
[Units: Community]
 18   18   36 
Age, Customized 
[Units: Participants]
Median (Inter-Quartile Range)
     
Participants Analyzed   13509   13964   27473 
Participants Analyzed   18   18   36 
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 
[Units: Participants]
Count of Participants
     
Participants Analyzed   13509   13964   27473 
Participants Analyzed   18   18   36 
Sex: Female, Male       
Female      716039777.8%      740141116.7%      1456140447.2% 
Male      634935272.2%      656336461.1%      1291235866.7% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   0   0   0 
Participants Analyzed   18   18   36 
Race and Ethnicity Not Collected         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Participants Analyzed   13509   13964   27473 
Participants Analyzed   18   18   36 
Tanzania   13509   13964   27473 


  Outcome Measures

1.  Primary:   TT Cases Screened Positive by CTA's and Confirmed by Graders   [ Time Frame: 10 months ]

2.  Secondary:   Sensitivity of TT Screening Methods   [ Time Frame: 10 months ]

3.  Secondary:   Specificity of TT Screening Methods   [ Time Frame: 10 months ]

4.  Secondary:   Positive Predictive Values of TT Screening Methods   [ Time Frame: 10 months ]

5.  Secondary:   Negative Predictive Values of TT Screening Methods   [ Time Frame: 10 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  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.


  More Information

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
e-mail: shwest@jhmi.edu



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