Kebele Elimination of Trachoma for Ocular Health (KETFO)

University of California San Francisco (UCSF)

Status and phase: Active, not recruiting; Phase 4

Conditions: Trachoma

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03335072

17-22201

1UG1EY028088 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320,000 participants in 4 patient groups

WHO-recommended

Active Comparator group

Description:

Annual mass azithromycin distribution of all residents

Treatment:

Drug: Azithromycin

Age-based core group

Experimental group

Description:

Annual mass azithromycin treatment of everyone plus quarterly treatment of children

Treatment:

Drug: Azithromycin

PCR infection-based core group

Experimental group

Description:

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

Treatment:

Drug: Azithromycin

TI-based core group

Experimental group

Description:

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

Treatment:

Drug: Azithromycin