Prevention of (via transmission interruption) and treatment of ocular infection with Chlamydia trachomatis in trachoma-endemic communities Infections and Infestations
Conditions
Interventions
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 ord
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Age
6 Months to 100 Years
Inclusion criteria
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 2 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
Exclusion criteria
Exclusion criteria: 1. Children under the age of 6 months for Standard Azithromycin Arms (one dose delivered by the national trachoma control programme) and under the age of 2 years in the Enhanced Azithromycin Arms (a second dose delivered in the context of the Trial) 2. Severe illness (defined as a condition that carries a high risk of mortality, where patients are acutely unwell or obtunded such that it would not be ethical to include them in the study) or incapacity (where, if the individual is under the age of 18 years of age, it is assumed on the grounds of immaturity that the child will be unable to make certain decisions such as whether to participate in a research study. In the case of children, those with parental responsibility can consent for them on their behalf. Where an adult lacks capacity, as with the case with certain mental illness, cognitive disorders or acutely due to drugs or alcohol toxicity, they would be excluded from the study. An adult lacking in the ability to understand information relevant to the decision, retain information long enough to be able to make the decision, use or weigh up the information or communicate the decision by any means by definition is deemed to lack decision-making capacity and would therefore be excluded from the study) 3. Inability to communicate 4. Known hypersensitivity to azithromycin 5. Known hypersensitivity to permethrin 6. Women who self report to be in the first trimester of pregnancy (for azithromycin). All women of childbearing age will be asked if they are pregnant. If they report pregnancy within the first trimester they will not be given azithromycin. If azithromycin is given inadvertently in the first trimester of pregnancy, because the woman did not know she was pregnant, this would not be a cause for concern because azithromycin is safe in pregnancy. 7. Confirmed to be taking medications that may cause a serious drug interaction if taken with azithromycin. At the point of enrolment to the study each participant will be screened to check that they are not taking any of the medications listed below at the time of azithromycin MDA and if they are, they will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Ethiopia
Contacts
Public ContactMatthew Burton
Outcome results
None listed