Identification of TT Cases by Community Treatment Assistants: An Assessment

NCT01783743 | Completed Results DMC

• 1 other identifier: NA_00043444
• Study Type: interventional
• Target: 27,473
• Locations: 1 country
• Sites: 1

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

Keywords

Trichiasis; Trachoma; Mass treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Sensitivity of TT Screening Methods

  10 months

• Specificity of TT Screening Methods

  10 months

• Positive Predictive Values of TT Screening Methods

  10 months

• Negative Predictive Values of TT Screening Methods

  10 months

Study Arms (2)

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.

Other: TT Training Program and TT Screening Card

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.

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Johns Hopkins University: lead
• Lions Club International Foundation: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Trichiasis; Trachoma

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Corneal Diseases

Limitations and Caveats

1. While use of CTAs in TT screening during MDA offers clear advantages, this approach is limited to areas that merit MDA. 2. Attrition of CTAs may also prove to be a limitation for this screening approach.

Results Point of Contact

• Title: Sheila K West
• Organization: Johns Hopkins University

shwest@jhmi.edu

410 955 2606

Study Officials

• Sheila K West, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 5, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 21, 2018
• Results First Posted: February 23, 2018

Record last verified: 2018-02

Locations

US (1)