Stronger SAFE: a community-based cluster-randomized trial to strengthen strategies to eliminate trachoma

INTERVENTION: The 68 clusters will be randomly allocated into four arms using a computer‐generated sequence, with an equal number of clusters in each arm (1:1:1:1). Restricted randomization may be considered in order to ensure balance between arms for any important cluster‐level variables at baseline. Once the clusters are allocated to the four arms, a statistician independent to the study will run a program to randomly allocate each of the four potential interventions summarised below: 1. Standard antibiotic / standard F&E (control) 2. Standard antibiotic / enhanced F&E 3. Enhanced antibiotic / standard F&E 4. Enhanced antibiotic / enhanced F&E (Stronger SAFE) Antibiotic Interventions: Oral azithromycin (Pfizer) will be provided by the International Trachoma Initiative. The height‐based dosage will follow the standard schedule, 20 mg/kg up to a maximum dose of 1g. 1. In Standard Antibiotic Arms: a single dose of oral azithromycin will be given to all individuals above 6 months of age as mass drug administration (MDA) given for three annual rounds. This is in accordance with the national policy for trachoma control and will be conducted by the regional trachoma control programme. 2. In Enhanced Antibiotic Arms: an additional single dose of oral azithromycin (20 mg/kg up to a maximum dose of 1 g) will be given 2 weeks after the programmatic MDA to all individuals above the age of 2 years for three annual rounds. F&E Interventions: 1. Standard F&E: Programmatic promotion of latrine construction and facial hygiene through health‐promotion messaging and collaboration with the WASH (Water, Sanitation, Hygiene) se CONDITION: Prevention of (via transmission interruption) and treatment of ocular infection with Chlamydia trachomatis in trachoma‐endemic communities ; Infections and Infestations PRIMARY OUTCOME: Cluster‐adjusted prevalence of ocular Chlamydia trachomatis (Ct) infection measured by quantitative real‐time PCR (polymerase chain reaction) detected on conjunctival swabs in children aged 1‐9 years at 36 months post‐intervention. The cluster level estimate of the prevalence of Ct will be based on a random sample of 60 children per cluster. SECONDARY OUTCOME: ; 1. Cluster‐adjusted prevalence of Ct infection measured using qPCR in children (1‐9 years) at baseline, 2, 12, 24, 26 months; 2. Cluster‐adjusted prevalence of TF and TI in children (1‐9 years) measured by conjunctival examination at baseline, 2, 12, 24, 26, 36 months; 3. Cluster‐adjusted proportion of children (1‐9 years) with clean faces measured using a facial cleanliness score at baseline, 2, 12, 24, 26, 36 months; 3. Fly (Musca sorrbens) density and diversity measured using trap counts and morphological identification each month from baseline throughout the trial (until 36 months); 4. Fly‐eye contact in children 2‐9 years of age measured using videography monthly from baseline throughout the trial (until 36 months); 5. Cluster‐adjusted mean daily frequency of good quality face washing among pre‐school, school‐age children and primary caregivers measured through household observations at baseline, 2, 12, 24, 26, 36 months; 6. Process indicators to measure exposure to, adherence and recall of the F&E interventions measured using a mixed‐methods approach at baseline, 3, 6, 12 and 24 months; 7. Cluster‐adjusted prevalence of malnutrition measured using anthropometry (height and weight for age z‐scores) in children (1‐60 months) at 24 and 36 months; 8. Cluster‐adjusted prevalence of clinic and hospital visits (specific and all‐cause) for children (1‐60 months) measured by caregiver recall at 24 and 36 months; 9. Cluster‐adjusted prevalence of diarrhoeal and respiratory illness in children (1‐60 months) measured by caregiver recall at 24 and 36 months; INCLUSION CRITERIA: Cluster residents eligible for interventions: 1. All individuals over the age of 6 months for Standard Azithromycin Arms (one dose delivered by the national trachoma control programme) and over the age of two years in the Enhanced Azithromycin Arms (a second dose delivered in the context of the Trial) 2. Informed consent (and assent where applicable) and to be randomly allocated to one of the four study arms 3. Do not fulfill exclusion criteria for administration of azithromycin Children eligible for assessment for outcomes: 1. All children between the ages of 1‐9 years inclusive 2. Informed consent and agreement of parent (or guardian as appropriate) for the child to participate