Sanitation, Water, and Instruction in Face-washing for Trachoma I/II

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

SWIFT I is a series of 3 cluster-randomized trials designed to assess several alternative strategies for trachoma control in communities that have been treated with many years of mass azithromycin distributions. The first trial (named WUHA) compares communities that receive a comprehensive Water, Sanitation, and Hygiene (WASH) package to those that receive no intervention. The second trial (named TAITU-A) compares communities randomized to targeted antibiotic treatment versus those randomized to mass antibiotics for trachoma, and the third trial (TAITU-B) compares communities randomized to targeted antibiotics versus those randomized to delayed antibiotics.

SWIFT II is a continuation of the first trial (WUHA I). WUHA I is an ongoing cluster-randomized trial in rural Ethiopia designed to determine the effectiveness of water, sanitation, and hygiene (WASH) for trachoma. 40 communities were randomized in a 1:1 ratio either to a comprehensive WASH package or to no intervention. The primary outcome is ocular chlamydia, monitored annually for 3 years.

In WUHA II we will treat all 40 WUHA communities with a single mass azithromycin distribution after the month 36 visit, and then continue the WASH intervention only in the 20 communities originally randomized to the WASH arm. We perform annual monitoring visits at months 48, 60, 72, and 84 for the primary outcome of ocular chlamydia among 0-5 year old children. A second aim of WUHA II is to perform a diagnostic test accuracy study of the tests already being conducted as well as several novel tests for trachoma surveillance. The novel tests include inexpensive, point-of-care nucleic acid amplification tests performed on conjunctival swabs, a lateral flow assay for chlamydia seropositivity tested on dried blood spots, and an automated algorithm to detect clinical signs of trachoma from conjunctival photographs. The primary objective of the second aim is to test the sensitivity and specificity of each of these trachoma surveillance tests.

By comparing the combined azithromycin-WASH communities to communities receiving mass azithromycin alone, we investigate the benefit of combining the "A", "F", and "E" components of the SAFE strategy as opposed to focusing on antibiotics alone. This is an important question given the expense of WASH interventions and the limited resources of trachoma programs.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Francis I. Proctor Foundation; University of California, San Francisco
• Collaborators: Amhara Public Health Institute; Bahir Dar Regional Health and Research Laboratory; Emory University; National Eye Institute (NEI); The Carter Center
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin; Tetracycline

Criteria

Community Level

• Inclusion Criteria

• Community in a school district that is within the study area of WagHimra

• Area within each school district with a site identified for water point construction

• At least 5 rounds of mass azithromycin distributions had been performed within community

• Exclusion Criteria:

• School districts that are too difficult to reach (more than a 1-day of travel to access)

• School districts in the 2 urban regions of the study area, since urban communities have better access to water and sanitation and have less trachoma

• Refusal of village chief

Individual Level

• Inclusion Criteria:

• All residents residing within a 1.5km radius from the most promising potential water point the water point sites within the school district that were identified for the study

• Exclusion criteria

• Refusal of participant [or parent/guardian]