Trachoma Elimination Study by Focused Antibiotic (TESFA)

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Brief Title

Trachoma Elimination Study by Focused Antibiotic (TESFA)

Official Title

Trachoma Elimination Study by Focused Antibiotic (TESFA): The Impact of an Enhanced Antibiotic Treatment Regimen on Trachoma in Amhara, Ethiopia

Brief Summary

      The study population consists of all households residing in eligible kebeles (sub-districts)
      within districts in Amhara National Regional State which are identified as having a high
      prevalence of trachoma and infection measured from recent trachoma impact assessments. Within
      each study kebele, one village will be randomly selected to serve as the sentinel study site
      for that kebele. Once these villages are chosen, the study team will use government-provided
      census records, or perform a census in each village, and will randomly choose 50 children to
      serve as the sentinel children for the study. After the baseline visit, all kebeles will be
      randomized into one of the two treatment arms to either receive standard-or-care treatment,
      which is an annual community-wide mass drug administration (MDA), or the enhanced antibiotic
      treatment. Recruitment will take place at the selected children's household. Oral informed
      consent will be sought from village leader/chairmen before surveys are conducted in a
      village. Oral informed consent will then be obtained from household heads of those houses
      included in the study; and then from each participating individual. Oral consents will be
      obtained given the low literacy rates in rural Amhara.

      Data collection will occur at baseline, week 4, month 12, and month 24 in both arms of the
      study. A head of household will be asked a series of household level questions, which will be
      followed by a household-level census, where all consenting participants residing in the
      selected households will have their eyes examined for trachoma signs. This is a non-invasive
      procedure whereby a trained trachoma grader flips each eyelid and examines for trachoma
      signs. Lastly, the selected child and one randomly selected adult will have their right eye
      lid swabbed for evidence of trachoma infection. The total estimated respondent burden is 30
      to 45 minutes.
    

Detailed Description

      Trachoma, caused by ocular infection with Chlamydia trachomatis, is one of the leading causes
      of preventable blindness worldwide with 51 countries known or suspected to be endemic for
      blinding trachoma. The World Health Organization (WHO) has recommended the Surgery,
      Antibiotic treatment, promotion of Facial cleanliness and hygiene, and Environmental
      improvement (SAFE) strategy for trachoma control. Annual mass drug administration (MDA) with
      the antibiotic azithromycin to treat trachoma is effective, at least in areas with moderate
      to low levels or trachoma. This has not been the experience in regions with high levels of
      trachoma including Amhara, Ethiopia. After 8 rounds of annual MDA, trachoma remains
      stubbornly high throughout the region. Given this experience from the Amhara region of
      Ethiopia, The Carter Center will work with local government partners at the regional, zonal,
      district, and sub-district levels to assess the effectiveness of a targeted antibiotic
      treatment regimen on trachoma prevalence by using a cluster randomized, controlled trial
      design with the understanding that increasing the need for drug in the short-term to
      intensify impact, may result in reduced need for drug in the long-term. The effectiveness of
      this alternative treatment regimen will be assessed over a period of 2 years by periodically
      evaluating trachoma outcomes throughout study communities.

      The key objectives of this study are to:

        1. To determine the effectiveness of an enhanced antibiotic treatment regimen characterized
           by a community-wide MDA followed by two rounds of targeted (to children age 2 to 9
           years) treatment in quick succession (1-2 weeks apart) compared to annual
           standard-of-care MDA.

        2. To determine the added cost and cost-effectiveness of an enhanced antibiotic treatment
           regimen compared to annual standard-of-care MDA.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Prevalence of Chlamydia trachomatis (CT) infection

Secondary Outcome

 Change in prevalence of trachomatous inflammation-follicular (TF)

Condition

Trachoma

Intervention

Azithromycin mass treatment

Study Arms / Comparison Groups

 Azithromycin mass treatment
Description:  Persons living in regions randomized to this arm will receive mass drug administration (MDA) of azithromycin per the current annual MDA schedule.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

53384

Start Date

January 2022

Completion Date

July 2023

Primary Completion Date

November 2022

Eligibility Criteria

        Cluster (kebele) Inclusion Criteria:

          -  The kebele must be located in Amhara and eligible for annual MDA with azithromycin
             under WHO treatment guidelines.

          -  Located within targeted districts where the prevalence of TF is high (at least 30%)
             and the prevalence of CT infection is suspected to be high (10% if possible) measured
             from the most recent trachoma impact assessment.

          -  The kebele representatives consent to participation in the trial.

        Gott (village) Inclusion Criteria:

          -  At least 50 children residing in the gott.

        Child Inclusion Criteria:

          -  Must reside in a cluster selected for this study.

          -  Must have a head of household or designated "adult-in-charge" who can provide consent
             for that child to be included in the study sample and to consent to allowing study
             staff to collect an ocular swab from the conjunctival epithelium.

          -  Child must assent to having a swab taken.

          -  Child must not have an ocular condition which would preclude grading trachoma or
             taking an ocular specimen.

        Exclusion Criteria:

          -  none
      

Gender

All

Ages

2 Years - 9 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kelly Callahan, MPH, , 

Location Countries

Ethiopia

Location Countries

Ethiopia

Administrative Informations


NCT ID

NCT03523156

Organization ID

IRB00085779


Responsible Party

Principal Investigator

Study Sponsor

Emory University

Collaborators

 The Carter Center

Study Sponsor

Kelly Callahan, MPH, Principal Investigator, The Carter Center


Verification Date

January 2021