Kebele Elimination of Trachoma for Ocular Health

NCT ID: NCT03335072

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

320000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2028-03-01

Brief Summary

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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

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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.

Conditions

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Trachoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WHO-recommended

Annual mass azithromycin distribution of all residents

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Mass Drug Administration

Age-based core group

Annual mass azithromycin treatment of everyone plus quarterly treatment of children

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Mass Drug Administration

PCR infection-based core group

Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group.

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Mass Drug Administration

TI-based core group

Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Mass Drug Administration

Interventions

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Azithromycin

Mass Drug Administration

Intervention Type DRUG

Other Intervention Names

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Zithromax

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Eyu-Ethiopia

UNKNOWN

Sponsor Role collaborator

Bahir Dar University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom M Lietman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Hadley Burroughs, MSPH

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

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UCSF Proctor Foundation

San Francisco, California, United States

Site Status

Eyu-Ethiopia

Bahir Dar, , Ethiopia

Site Status

Countries

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United States Ethiopia

Other Identifiers

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1UG1EY028088

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-22201

Identifier Type: -

Identifier Source: org_study_id

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