Kebele Elimination of Trachoma for Ocular Health
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/2/2018 |
| Start Date: | June 1, 2019 |
| End Date: | July 1, 2022 |
| Contact: | Tom M Lietman, MD |
| Email: | Tom.Lietman@ucsf.edu |
| Phone: | 415-502-2662 |
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.
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.
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.
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.
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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