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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Lions Club International Foundation
Information provided by (Responsible Party):
Sheila K West, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01783743
First received: January 30, 2013
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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 complain, 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.

Thirty-six villages, for which 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 sets of villages the CTAs will keep records of all cases they have screened as positive for TT.

A Master TT grader will grade all screened cases of TT to determine the rate of true positivity. 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. 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 Intervention
Trichiasis
Other: TT Training Program and Recognition Card

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Identification of TT Cases by Community Treatment Assistants: An Assessment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • TT Cases Detected [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Number of TT cases detected in intervention versus control arms (adjusted for population size) through screening


Secondary Outcome Measures:
  • Sensitivity and Specificity of TT Screening Methods [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Sensitivity and specificity of the different TT screening methods compared to "true" assessment of cases and controls

  • Positive and Negative Predictive Values of TT Screening Methods [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Positive and Negative Predictive Values of the different screening methods compared to "true" assessment of cases and controls


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
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.
Other: 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.
No Intervention: Usual Assessment
Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783743

Contacts
Contact: Sheila K West, PhD 410-955-2606 shwest@jhmi.edu
Contact: Gregory S Greene, BS 678-596-0754 ggreene@jhsph.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Sheila K West, PhD    410-955-2606    shwest@jhmi.edu   
Principal Investigator: Sheila K West, PhD         
Sponsors and Collaborators
Johns Hopkins University
Lions Club International Foundation
Investigators
Principal Investigator: Sheila K West, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sheila K West, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01783743     History of Changes
Other Study ID Numbers: NA_00043444
Study First Received: January 30, 2013
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Johns Hopkins University:
Trichiasis
Trachoma
Mass treatment

Additional relevant MeSH terms:
Trichiasis
Eye Diseases
Eyelid Diseases

ClinicalTrials.gov processed this record on October 20, 2014