Trachoma Elimination Study by Focused Antibiotic (TESFA)

• Status: Suspended
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study population consists of all households residing in eligible kebeles (sub-districts) within districts in Amhara National Regional State which are identified as having a high prevalence of trachoma and infection measured from recent trachoma impact assessments. Within each study kebele, one village will be randomly selected to serve as the sentinel study site for that kebele. Once these villages are chosen, the study team will use government-provided census records, or perform a census in each village, and will randomly choose 50 children to serve as the sentinel children for the study. After the baseline visit, all kebeles will be randomized into one of the two treatment arms to either receive standard-or-care treatment, which is an annual community-wide mass drug administration (MDA), or the enhanced antibiotic treatment. Recruitment will take place at the selected children's household. Oral informed consent will be sought from village leader/chairmen before surveys are conducted in a village. Oral informed consent will then be obtained from household heads of those houses included in the study; and then from each participating individual. Oral consents will be obtained given the low literacy rates in rural Amhara.

Data collection will occur at baseline, week 4, month 12, and month 24 in both arms of the study. A head of household will be asked a series of household level questions, which will be followed by a household-level census, where all consenting participants residing in the selected households will have their eyes examined for trachoma signs. This is a non-invasive procedure whereby a trained trachoma grader flips each eyelid and examines for trachoma signs. Lastly, the selected child and one randomly selected adult will have their right eye lid swabbed for evidence of trachoma infection. The total estimated respondent burden is 30 to 45 minutes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: The Carter Center
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin

Criteria

Cluster (kebele) Inclusion Criteria:

• The kebele must be located in Amhara and eligible for annual MDA with azithromycin under WHO treatment guidelines.

• Located within targeted districts where the prevalence of TF is high (at least 30%) and the prevalence of CT infection is suspected to be high (10% if possible) measured from the most recent trachoma impact assessment.

• The kebele representatives consent to participation in the trial.

Gott (village) Inclusion Criteria:

• At least 50 children residing in the gott.

Child Inclusion Criteria:

• Must reside in a cluster selected for this study.

• Must have a head of household or designated "adult-in-charge" who can provide consent for that child to be included in the study sample and to consent to allowing study staff to collect an ocular swab from the conjunctival epithelium.

• Child must assent to having a swab taken.

• Child must not have an ocular condition which would preclude grading trachoma or taking an ocular specimen.

Exclusion Criteria:

• none