Kebele Elimination of Trachoma for Ocular Health

Last updated: March 6, 2024
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

4

Condition

Eyelid Inflammation

Treatment

Azithromycin

Clinical Study ID

NCT03335072
17-22201
1UG1EY028088
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All individuals in all communities will be eligible for annual mass azithromycindistribution per WHO guidelines.

Exclusion

Exclusion Criteria:

  • Those who do not consent.

Study Design

Total Participants: 320000
Treatment Group(s): 1
Primary Treatment: Azithromycin
Phase: 4
Study Start date:
February 07, 2022
Estimated Completion Date:
March 01, 2028

Study 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.

Connect with a study center

  • The Carter Center

    Addis Ababa,
    Ethiopia

    Site Not Available

  • Eyu-Ethiopia

    Bahir Dar,
    Ethiopia

    Active - Recruiting

  • UCSF Proctor Foundation

    San Francisco, California 94143
    United States

    Site Not Available

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