Identification of TT Cases by Community Treatment Assistants: An Assessment

NCT ID: NCT01783743

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

Trichiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

TT Training Program and TT Screening Card

Intervention Type: 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.

Usual Assessment arm

Community treatment assistants will receive only usual training, including the basic background of trachoma/trichiasis recognition, drug administration, and azithromycin dosing.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lions Club International Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila K West, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00043444

Identifier Type: -

Identifier Source: org_study_id