| Trial name or title |
Sanitation, water, and instruction in face‐washing for trachoma |
| Methods |
Clinical trial |
| Participants |
Estimated enrolment: 220,000
Inclusion criteria
Community in a school district that is within the study area Area within each school district that is in need of a well All residents residing near to the well sites that are randomly selected for this study.
Exclusion criteria
School districts that are too difficult to reach (more than a 3‐hour walk from the farthest place reachable by a four‐wheel drive vehicle) School districts in the 2 urban regions of the study area Refusal of village chief Refusal of participant [or parent/guardian]
|
| Interventions |
Behavioral: water, sanitation, and hygiene (WASH) intervention Behavioral: standard of care WASH intervention Drug: azithromycin Drug: tetracycline Other: control Drug: albendazole |
| Outcomes |
Primary
Village‐specific ocular chlamydia among 0‐5 children over time Ocular chlamydia among 8‐12 year olds Incident ocular chlamydia in 0‐5 year‐olds Trial‐based cost‐effectiveness of intervention (intervention costs per percent of chlamydia reduction)
Secondary
Quantitative PCR chlamydia load Inflammatory trachoma scores Ocular chlamydia Nasopharyngeal pneumococcal macrolide resistance Proportion of the population with clean faces at the village level Childhood growth (height) Childhood growth (weight) Soil‐transmitted helminth prevalence Soil‐transmitted helminth density Prevalence of chlamydia and other antigen positivity from serological tests Prevalence of stool‐based antigen
|
| Starting date |
November 2015 |
| Contact information |
Dionna M Fry, MPH
Jeremy D Keenan, MD, MPH |
| Notes |
ClinicalTrials.gov identifier: NCT02754583
Sources of support: Francis I. Proctor Foundation, The Carter Center, Bahir Dar Regional Health and Research Laboratory, Emory University, National Eye Institute (NEI)
Anticipated completion July 2019 |
