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

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.

Conditions

• Trachoma

Interventions

BEHAVIORAL

Water, sanitation, and hygiene (WASH) intervention

WASH arm: Communities will receive the water, sanitation, and hygiene (WASH) intervention including water point construction and maintenance, hygiene and sanitation education and promotion, community-based hygiene promotion workers, household wash stations, household WASH education books, household soap distribution, and a hygiene curriculum for primary schools.

BEHAVIORAL

Standard of care WASH intervention

Stand of care WASH arm

DRUG

Azithromycin

20mg/kg

DRUG

Tetracycline

Tetracycline will be administered in lieu of azithromycin if individual is under 6 months, has a known azithromycin allergy, or is severely ill.

OTHER

Control

The control group will receive no intervention during the trial. They will be enrolled in mass antibiotic treatment at the conclusion of the trial.

Sponsors & Collaborators

• The Carter Center

  collaborator OTHER

• Amhara Public Health Institute

  collaborator UNKNOWN

• Emory University

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Zerihun Tadese, MD, MPH · The Carter Center Ethiopia

• Jeremy D Keenan, MD, MPH · University of California San Francisco Proctor Foundation

• Dionna M Wittberg, MPH · UCSF Proctor Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

120 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-12-05

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Ethiopia

Study Locations