Identification of TT Cases by Community Treatment Assistants: An Assessment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01783743

Acronym

SIMBA

Enrollment

27473

Registered

2013-02-05

Start date

2013-02-28

Completion date

2013-12-31

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trichiasis

Keywords

Trichiasis, Trachoma, Mass treatment

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.

Interventions

OTHERTT 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
TT Cases Screened Positive by CTA's and Confirmed by Graders	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

Measure	Time frame	Description
Sensitivity of TT Screening Methods	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)
Specificity of TT Screening Methods	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)
Positive Predictive Values of TT Screening Methods	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.
Negative Predictive Values of TT Screening Methods	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

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
Control (Usual Assessment) Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.	13,509
Control (Usual Assessment) Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.	18
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.	13,964
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.	18
Total	27,509

Withdrawals & dropouts

Period	Reason	FG000	FG001
Rescreening of Subjects by Senior Grader	Lost to Follow-up	591	684
Rescreening of Subjects by Senior Grader	Not part of the random sample selected	10,305	10,236
Screening of Subjects by CTA During MDA	Absent at MDA	3,427	4,439

Baseline characteristics

Characteristic	Intervention (Novel TT Screening Tool)	Total	Control (Usual Assessment)
Age, Customized 15-39 years	482 participants	488 participants	494 participants
Age, Customized 40-59 years	152 participants	160 participants	168 participants
Age, Customized 60 and older	83 participants	82 participants	81 participants
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Tanzania	13964 Participants	27473 Participants	13509 Participants
Sex: Female, Male Female	7401 Participants	14561 Participants	7160 Participants
Sex: Female, Male Male	6563 Participants	12912 Participants	6349 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 13,509	0 / 13,964
serious Total, serious adverse events	0 / 13,509	0 / 13,964

Arm	Measure	Value (NUMBER)
Control (Usual Assessment)	Specificity of TT Screening Methods	99.7 percentage of true negatives
Intervention (Novel TT Screening Tool)	Specificity of TT Screening Methods	98.0 percentage of true negatives

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026