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| Name | Class |
|---|---|
| Lions Club International Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
|
| Usual Assessment arm | No Intervention | Community treatment assistants will receive only usual training, including the basic background of trachoma/trichiasis recognition, drug administration, and azithromycin dosing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT Training Program and TT Screening Card | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 10 months |
| Specificity of TT Screening Methods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheila K West, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Control (Usual Assessment) | Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening of Subjects by CTA During MDA |
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| ||||||||||||||||||
| Rescreening of Subjects by Senior Grader |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Usual Assessment) | Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing. |
| BG001 | Intervention (Novel TT Screening Tool) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 10 months |
|
10 months (Between January 2013 to November 2013)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (Usual Assessment) | Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheila K West | Johns Hopkins University | 410 955 2606 | shwest@jhmi.edu |
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| ID | Term |
|---|---|
| D058457 | Trichiasis |
| D014141 | Trachoma |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D003234 | Conjunctivitis, Bacterial |
| D015818 | Eye Infections, Bacterial |
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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) |
| 10 months |
| 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. | 10 months |
| 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 | 10 months |
| Random Sample From Non TT Cases by CTA |
|
| Random Sample From Subject Absent at MDA |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| community |
|
| participants |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
|
|
| Secondary | 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) | Posted | Number | 95% Confidence Interval | percentage of true positives | 10 months |
|
|
|
| Secondary | 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) | Posted | Number | 95% Confidence Interval | percentage of true negatives | 10 months |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of true positives | 10 months |
|
|
|
| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of true negatives | 10 months |
|
|
|
| 0 |
| 13,509 |
| 0 |
| 13,509 |
| EG001 | 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. | 0 | 13,964 | 0 | 13,964 |
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| D001424 |
| Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D002690 | Chlamydia Infections |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D003316 | Corneal Diseases |