Kebele Elimination of Trachoma for Ocular Health (KETFO)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2028
  • participants needed
    320000
  • sponsor
    University of California, San Francisco
Updated on 11 March 2022

Summary

The investigators propose a cluster-randomized clinical trial to determine whether an intensive, targeted azithromycin distribution strategy is effective for elimination of trachoma at the kebele level compared to the World Health Organization (WHO) recommendation of annual azithromycin distribution.

Description

The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36 months.

Details
Condition Trachoma
Treatment Azithromycin
Clinical Study IdentifierNCT03335072
SponsorUniversity of California, San Francisco
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines

Exclusion Criteria

Those who do not consent
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