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

NCT02754583 | Completed Phase 3 DMC

• 2 other identifiers: 14-14004U10EY023939
• Study Type: interventional
• Target: 47,605
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

trachoma; soil transmitted helminths; sanitation; face washing; antibiotics

Outcome Measures

Primary Outcomes (4)

• Village-specific ocular chlamydia among 0-5 children over time (first trial: WUHA)

  Multiple time points will be used in a mixed effects regression model of the village-specific ocular chlamydia prevalences over time in 0-5 year olds as assessed by PCR.

  12, 24, 36, 48, 60, 84, 96 months

• Ocular chlamydia among 8-12 year olds (second trial: TAITU-A)

  Cluster-specific prevalence of ocular chlamydia among individuals aged 8-12 years, compared between the targeted azithromycin arm and the mass azithromycin arm.

  24 months

• Incident ocular chlamydia in 0-5 year-olds (third trial: TAITU-B)

  Incidence of new ocular chlamydia infection in 0-5 year-olds, compared between the targeted azithromycin arm and the delayed mass azithromycin arm.

  24 months

• Trial-based cost-effectiveness of intervention (intervention costs per percent of chlamydia reduction)

  The short term analysis is designed to provide insight into whether each intervention (WASH or targeted antibiotics) is effective for our primary trial outcome of reducing ocular chlamydial infection in children. The time horizon of these analyses will be the duration of each trial.

  24 months for TAITU, 36 months for WUHA

Secondary Outcomes (16)

• Quantitative PCR chlamydia load

  12, 24, 36, 48, 60, 84, 96 months

• Follicular trachoma scores; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU)

  12, 24, 36, 48, 60, 84, 96 months

• Inflammatory trachoma scores; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU)

  12, 24, 36, 48, 60, 84, 96 months

• Clinical trachoma improvement as measured in photography

  12, 24, 36, 48, 60, 84, 96 months

• Chlamydial load, individual level analysis

  12, 24, 36, 48, 60, 84, 96 months

Study Arms (5)

WASH arm (WUHA)

EXPERIMENTAL

WUHA I, Behavioral: Water, sanitation, and hygiene (WASH) intervention: Communities will receive the water, sanitation, and hygiene (WASH) intervention including community water point construction, 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. WUHA II, Behavioral and Treatment: WASH intervention communities will continue to receive the water, sanitation, and hygiene (WASH) intervention. A single mass azithromycin distribution will be given in all 40 WUHA I communities (both intervention and control) after the final study visit (i.e., month 36). Children 6 months and up will be offered azithromycin 20mg/kg; those under 6 months will be offered tetracycline.

Behavioral: Water, sanitation, and hygiene (WASH) intervention; Drug: Azithromycin; Drug: Tetracycline

Standard of care WASH arm (WUHA)

OTHER

WUHA I: Standard of care WASH intervention: Communities will continue to receive the standard of care WASH programming offered by the Ethiopian government. WUHA II: Standard of care WASH intervention and treatment: Communities will continue to receive the standard of care WASH programming offered by the Ethiopian government. A single mass azithromycin distribution will be given in all 40 WUHA I communities (both intervention and control) after the final study visit (i.e., month 36). Children 6 months and up will be offered azithromycin 20mg/kg; those under 6 months will be offered tetracycline. These communities will receive a WASH package at the conclusion of the SWIFT II study, including water point construction, hygiene and sanitation promotion, and educational materials.

Behavioral: Standard of care WASH intervention; Drug: Azithromycin; Drug: Tetracycline

Targeted antibiotics arm (TAITU)

EXPERIMENTAL

Targeted antibiotic treatment: Communities will receive targeted antibiotic treatments for children testing positive for ocular chlamydia at 3, 6, 9, and 12 months after baseline testing. After testing for ocular chlamydia at 12 months, any children testing positive at this time point will receive antibiotic treatments at 15, 18, 21, and 24 months. Children 6 months and up will be offered azithromycin 20mg/kg; those under 6 months will be offered tetracycline.

Drug: Azithromycin; Drug: Tetracycline

Delayed mass antibiotics arm (TAITU)

OTHER

Delayed mass antibiotic treatment: Communities will receive no mass azithromycin treatment during the study period. Communities in this treatment group have previously received at least 8 rounds of mass azithromycin treatment. These clusters will be enrolled in an antibiotics treatment program (azithromycin or tetracycline) after the completion of the study.

Other: Control

Mass antibiotics arm (TAITU)

ACTIVE COMPARATOR

Mass antibiotic treatment: Communities will receive mass azithromycin treatment of all individuals aged 6 months and up (20mg/kg for children; 1 g for adults); those younger than 6 months, pregnant, or allergic to macrolide antibiotics will be offered a 2-week course of tetracycline.

Drug: Azithromycin; Drug: Tetracycline

Interventions

Standard of care WASH intervention BEHAVIORAL

Stand of care WASH arm

Also known as: WUHA

Standard of care WASH arm (WUHA)

Azithromycin DRUG

20mg/kg

Mass antibiotics arm (TAITU); Standard of care WASH arm (WUHA); Targeted antibiotics arm (TAITU); WASH arm (WUHA)

Tetracycline DRUG

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

Mass antibiotics arm (TAITU); Standard of care WASH arm (WUHA); Targeted antibiotics arm (TAITU); WASH arm (WUHA)

Control OTHER

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

Delayed mass antibiotics arm (TAITU)

Water, sanitation, and hygiene (WASH) intervention BEHAVIORAL

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.

Also known as: WASH Upgrades for Health in Amhara (WUHA)

WASH arm (WUHA)

Eligibility Criteria

• Age: 1 Day - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Refusal of participant \[or parent/guardian\]

Sponsors & Collaborators

• University of California, San Francisco: lead
• The Carter Center: collaborator
• Amhara Public Health Institute: collaborator
• Emory University: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

The Carter Center Ethiopia

Addis Ababa, Ethiopia

Location

Related Publications (6)

• Wittberg DM, Admassu F, Aragie S, Dagnew A, Hailu D, Tadesse Z, Zeru T, Thompson IJB, Abdu S, Beyecha S, Birhanu T, Getachew H, Getnet B, Kabtu E, Shibiru M, Tekew S, Wondimteka B, Freeman MC, Nash SD, Lietman TM, Keenan JD. The Effect of a Water, Sanitation, and Hygiene Intervention on Clinical Trachoma: A Cluster-Randomised Trial. Trop Med Int Health. 2026 Apr;31(4):457-464. doi: 10.1111/tmi.70086. Epub 2026 Jan 18.

  PMID: 41548574 DERIVED

• Frank T, Thompson IJB, Aragie S, Wittberg DM, Tadesse W, Dagnew A, Hailu D, Melo JS, Zeru T, Tadesse Z, Arnold BF, Freeman MC, Nash SD, Callahan EK, Porco TC, Lietman TM, Keenan JD. Effect of water, sanitation, and hygiene on childhood growth in Ethiopia: a cluster-randomized trial. Int J Hyg Environ Health. 2026 Jan;271:114718. doi: 10.1016/j.ijheh.2025.114718. Epub 2025 Nov 27.

  PMID: 41314021 DERIVED

• Caleon RL, Admassu F, Aragie S, Hailu D, Dagnew A, Zeru T, Wittberg DM, Thompson IJB, Abdu S, Beyecha S, Birhanu T, Getachew H, Getnet B, Kabtu E, Shibiru M, Tekew S, Wondimteka B, Lietman TM, Nash SD, Freeman MC, Keenan JD. Photographic grading to evaluate facial cleanliness and trachoma among children in Amhara region, Ethiopia. PLoS Negl Trop Dis. 2024 Jul 11;18(7):e0012257. doi: 10.1371/journal.pntd.0012257. eCollection 2024 Jul.

  PMID: 38991011 DERIVED

• Tedijanto C, Aragie S, Gwyn S, Wittberg DM, Zeru T, Tadesse Z, Chernet A, Thompson IJB, Nash SD, Lietman TM, Martin DL, Keenan JD, Arnold BF. Seroreversion to Chlamydia trachomatis Pgp3 Antigen Among Children in a Hyperendemic Region of Amhara, Ethiopia. J Infect Dis. 2024 Aug 16;230(2):293-297. doi: 10.1093/infdis/jiad602.

  PMID: 38134305 DERIVED

• Aragie S, Wittberg DM, Tadesse W, Dagnew A, Hailu D, Chernet A, Melo JS, Aiemjoy K, Haile M, Zeru T, Tadesse Z, Gwyn S, Martin DL, Arnold BF, Freeman MC, Nash SD, Callahan EK, Porco TC, Lietman TM, Keenan JD. Water, sanitation, and hygiene for control of trachoma in Ethiopia (WUHA): a two-arm, parallel-group, cluster-randomised trial. Lancet Glob Health. 2022 Jan;10(1):e87-e95. doi: 10.1016/S2214-109X(21)00409-5.

  PMID: 34919861 DERIVED

• Wittberg DM, Aragie S, Tadesse W, Melo JS, Aiemjoy K, Chanyalew M, Emerson PM, Freeman MC, Nash SD, Callahan EK, Tadesse Z, Zerihun M, Porco TC, Lietman TM, Keenan JD. WASH Upgrades for Health in Amhara (WUHA): study protocol for a cluster-randomised trial in Ethiopia. BMJ Open. 2021 Feb 22;11(2):e039529. doi: 10.1136/bmjopen-2020-039529.

  PMID: 33619183 DERIVED

MeSH Terms

Conditions

Trachoma

Interventions

Water; Sanitation; Hygiene; Therapeutic Irrigation; Methods; Health; Azithromycin; Tetracycline

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Therapeutics; Hydrotherapy; Physical Therapy Modalities; Rehabilitation; Investigative Techniques; Population Characteristics; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Zerihun Tadese, MD, MPH

  The Carter Center Ethiopia

  STUDY DIRECTOR

• Jeremy D Keenan, MD, MPH

  University of California San Francisco Proctor Foundation

  PRINCIPAL INVESTIGATOR

• Dionna M Wittberg, MPH

  UCSF Proctor Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: April 28, 2016
• Study Start: December 5, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

ET (1)