Trachoma Elimination Study by Focused Antibiotic (TESFA)
Status:
Suspended
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
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.