Trial Outcomes & Findings for Identification of TT Cases by Community Treatment Assistants: An Assessment (NCT NCT01783743)
NCT ID: NCT01783743
Last Updated: 2018-03-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27473 participants
Primary outcome timeframe
10 months
Results posted on
2018-03-21
Participant Flow
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.
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.
Unit of analysis: communities
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Screening of Subjects by CTA During MDA
STARTED
|
13509 18
|
13964 18
|
|
Screening of Subjects by CTA During MDA
COMPLETED
|
10082 18
|
9525 18
|
|
Screening of Subjects by CTA During MDA
NOT COMPLETED
|
3427 0
|
4439 0
|
|
Rescreening of Subjects by Senior Grader
STARTED
|
13509 18
|
13964 18
|
|
Rescreening of Subjects by Senior Grader
TT Positive Cases Screened by CTA
|
46 18
|
409 18
|
|
Rescreening of Subjects by Senior Grader
Random Sample From Non TT Cases by CTA
|
1721 18
|
1786 18
|
|
Rescreening of Subjects by Senior Grader
Random Sample From Subject Absent at MDA
|
846 18
|
849 18
|
|
Rescreening of Subjects by Senior Grader
COMPLETED
|
2613 18
|
3044 18
|
|
Rescreening of Subjects by Senior Grader
NOT COMPLETED
|
10896 0
|
10920 0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Screening of Subjects by CTA During MDA
Absent at MDA
|
3427
|
4439
|
|
Rescreening of Subjects by Senior Grader
Lost to Follow-up
|
591
|
684
|
|
Rescreening of Subjects by Senior Grader
Not part of the random sample selected
|
10305
|
10236
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control (Usual Assessment)
n=18 community
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
|
Intervention (Novel TT Screening Tool)
n=18 community
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
n=36 community
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
15-39 years
|
494 participants
n=13509 Participants
|
482 participants
n=13964 Participants
|
488 participants
n=27473 Participants
|
|
Age, Customized
40-59 years
|
168 participants
n=13509 Participants
|
152 participants
n=13964 Participants
|
160 participants
n=27473 Participants
|
|
Age, Customized
60 and older
|
81 participants
n=13509 Participants
|
83 participants
n=13964 Participants
|
82 participants
n=27473 Participants
|
|
Sex: Female, Male
Female
|
7160 Participants
n=13509 Participants
|
7401 Participants
n=13964 Participants
|
14561 Participants
n=27473 Participants
|
|
Sex: Female, Male
Male
|
6349 Participants
n=13509 Participants
|
6563 Participants
n=13964 Participants
|
12912 Participants
n=27473 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Tanzania
|
13509 Participants
n=13509 Participants
|
13964 Participants
n=13964 Participants
|
27473 Participants
n=27473 Participants
|
PRIMARY outcome
Timeframe: 10 monthsAll 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.
Outcome measures
| Measure |
Control (Usual Assessment)
n=32 Participants
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
|
Intervention (Novel TT Screening Tool)
n=316 Participants
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.
|
|---|---|---|
|
TT Cases Screened Positive by CTA's and Confirmed by Graders
|
9 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 10 monthsSensitivity 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)
Outcome measures
| Measure |
Control (Usual Assessment)
n=46 Participants
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
|
Intervention (Novel TT Screening Tool)
n=409 Participants
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.
|
|---|---|---|
|
Sensitivity of TT Screening Methods
|
5.7 percentage of true positives
Interval 2.6 to 8.6
|
31.2 percentage of true positives
Interval 24.9 to 37.6
|
SECONDARY outcome
Timeframe: 10 monthsSpecificity 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)
Outcome measures
| Measure |
Control (Usual Assessment)
n=10036 Participants
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
|
Intervention (Novel TT Screening Tool)
n=9116 Participants
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.
|
|---|---|---|
|
Specificity of TT Screening Methods
|
99.7 percentage of true negatives
Interval 99.6 to 99.8
|
98.0 percentage of true negatives
Interval 97.6 to 98.2
|
SECONDARY outcome
Timeframe: 10 monthsPositive 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.
Outcome measures
| Measure |
Control (Usual Assessment)
n=46 Participants
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
|
Intervention (Novel TT Screening Tool)
n=409 Participants
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.
|
|---|---|---|
|
Positive Predictive Values of TT Screening Methods
|
28.1 percentage of true positives
Interval 15.1 to 41.1
|
15.8 percentage of true positives
Interval 12.3 to 19.4
|
SECONDARY outcome
Timeframe: 10 monthsNegative 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
Outcome measures
| Measure |
Control (Usual Assessment)
n=10036 Participants
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
|
Intervention (Novel TT Screening Tool)
n=9116 Participants
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.
|
|---|---|---|
|
Negative Predictive Values of TT Screening Methods
|
98.0 percentage of true negatives
Interval 97.6 to 98.2
|
2.2 percentage of true negatives
Interval 2.0 to 2.5
|
Adverse Events
Control (Usual Assessment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention (Novel TT Screening Tool)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place