TrichiasisSIMBANCT01783743
Identification of TT Cases by Community Treatment Assistants: An Assessment
A study testing TT Training Program and TT Screening Card in people with Trichiasis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Trichiasis
- What is being tested?
- TT Training Program and TT Screening Card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,473 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- TT Training Program and TT Screening Card
- Keywords
- Trichiasis, Trachoma, Mass treatment
- Medical subject headings
- Trichiasis, Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT Training Program and TT Screening CardOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Secondary outcomes (4)
Sensitivity of TT Screening Methods
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)
Measured: 10 months
Specificity of TT Screening Methods
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)
Measured: 10 months
Positive Predictive Values of TT Screening Methods
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.
Measured: 10 months
Negative Predictive Values of TT Screening Methods
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
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TrichiasisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27,473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Lions Club International Foundation
- Responsible party
- Sponsor
- Investigators
- Sheila K West, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783743
- Sponsor's protocol ID
- NA_00043444
- Acronym
- SIMBA
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2013
- Last updated
- 21 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of TT Cases by Community Treatment Assistants: An Assessment
- ClinicalTrials.gov ID
- NCT01783743
- Acronym / sponsor ID
- SIMBA / NA_00043444
- Conditions
- Trichiasis
- Keywords
- Trichiasis, Trachoma, Mass treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,473 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Lions Club International Foundation
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 23 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: TT Training Program and TT Screening CardCommunity 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. |
| 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TT Training Program and TT Screening CardThe 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. | Other | Intervention arm |
Primary outcome
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.
4 secondary outcomes
Sensitivity of TT Screening Methods
Time frame: 10 months
Specificity of TT Screening Methods
Time frame: 10 months
Positive Predictive Values of TT Screening Methods
Time frame: 10 months
Negative Predictive Values of TT Screening Methods
Time frame: 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Trichiasis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila K West, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TT Training Program and TT Screening Card in people with Trichiasis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TT Cases Screened Positive by CTA's and Confirmed by Graders (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.