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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

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.


Condition or disease Intervention/treatment Phase
Trichiasis Other: TT Training Program and TT Screening Card Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27473 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Identification of TT Cases by Community Treatment Assistants: An Assessment
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Intervention arm

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.

Other: TT Training Program and TT Screening Card
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.

No Intervention: Usual Assessment arm
Community treatment assistants will receive only usual training, including the basic background of trachoma/trichiasis recognition, drug administration, and azithromycin dosing.



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

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

    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)


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

    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)


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

    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.


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

    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




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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783743


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Lions Club International Foundation
Investigators
Principal Investigator: Sheila K West, PhD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01783743     History of Changes
Other Study ID Numbers: NA_00043444
First Posted: February 5, 2013    Key Record Dates
Results First Posted: February 23, 2018
Last Update Posted: March 21, 2018
Last Verified: February 2018

Keywords provided by Johns Hopkins University:
Trichiasis
Trachoma
Mass treatment

Additional relevant MeSH terms:
Trichiasis
Eyelid Diseases
Eye Diseases