Brief Title
Kebele Elimination of Trachoma for Ocular Health
Official Title
Kebele Elimination of Trachoma for Ocular Health
Brief 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.
Detailed 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Ocular chlamydia measured in a population based age-stratified sample of the entire community
Secondary Outcome
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia
Condition
Trachoma
Intervention
Azithromycin
Study Arms / Comparison Groups
WHO-recommended
Description: Annual mass azithromycin distribution of all residents
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
320000
Start Date
February 7, 2022
Completion Date
March 1, 2028
Primary Completion Date
March 1, 2027
Eligibility Criteria
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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Tom M Lietman, MD, 415-502-2662, [email protected]
Location Countries
Ethiopia
Location Countries
Ethiopia
Administrative Informations
NCT ID
NCT03335072
Organization ID
17-22201
Secondary IDs
1UG1EY028088
Responsible Party
Sponsor
Study Sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI)
Study Sponsor
Tom M Lietman, MD, Principal Investigator, University of California, San Francisco
Verification Date
February 2022