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

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ClinicalTrials.gov Identifier: NCT02754583
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
The Carter Center
Bahir Dar Regional Health and Research Laboratory
Emory University
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jeremy Keenan, Francis I. Proctor Foundation

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. WUHA II also provides information


Condition or disease Intervention/treatment Phase
Trachoma Behavioral: Water, sanitation, and hygiene (WASH) intervention Behavioral: Standard of care WASH intervention Drug: Azithromycin Drug: Tetracycline Other: Control Drug: Albendazole Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sanitation, Water, and Instruction in Face-washing for Trachoma I/II
Actual Study Start Date : November 1, 2015
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: WASH arm (WUHA)

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
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.
Other Name: WASH Upgrades for Health in Amhara (WUHA)

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.

Standard of care WASH arm (WUHA)

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 SWIIFT II study, including water point construction, hygiene and sanitation promotion, and educational materials.

Behavioral: Standard of care WASH intervention
Stand of care WASH arm
Other Name: WUHA

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.

Experimental: Targeted antibiotics arm (TAITU)
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
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.

Delayed mass antibiotics arm (TAITU)
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
The control group will receive no intervention during the trial. They will be enrolled in mass antibiotic treatment at the conclusion of the trial.

Active Comparator: Mass antibiotics arm (TAITU)
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
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.

Experimental: Intestinal microbiome
Children will be randomized in a factorial design to oral albendazole treatment on day 0 versus albendazole treatment on day 7, and to azithromycin treatment on day 0 versus azithromycin treatment on day 7. Note that all children will receive both a single dose of azithromycin and a single dose of albendazole; the only difference is that the doses will be spaced 1 week apart.
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.

Drug: Albendazole



Primary Outcome Measures :
  1. Village-specific ocular chlamydia among 0-5 children over time (first trial: WUHA) [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    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.

  2. Ocular chlamydia among 8-12 year olds (second trial: TAITU-A) [ Time Frame: 24 months ]
    Cluster-specific prevalence of ocular chlamydia among individuals aged 8-12 years, compared between the targeted azithromycin arm and the mass azithromycin arm.

  3. Incident ocular chlamydia in 0-5 year-olds (third trial: TAITU-B) [ Time Frame: 24 months ]
    Incidence of new ocular chlamydia infection in 0-5 year-olds, compared between the targeted azithromycin arm and the delayed mass azithromycin arm.

  4. Trial-based cost-effectiveness of intervention (intervention costs per percent of chlamydia reduction) [ Time Frame: 24 months for TAITU, 36 months for WUHA ]
    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.


Secondary Outcome Measures :
  1. Quantitative PCR chlamydia load [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]

    The analysis is proposed to be identical to that of the ocular chlamydia outcome, except that a village-specific index of chlamydia load at baseline and at follow-up times is used instead of prevalence. The analysis is two-sided at an alpha of 0.05.

    This is a prespecified secondary analysis and will be reported as such.


  2. Follicular trachoma scores; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU) [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    Follicular trachoma scores (using the 5 level system) will be modeled longitudinally using linear mixed effects regression. Scores are indexed by participant, grader, visit, and village. Participant and village will be modeled as random effects; grader will be modeled as a fixed effect. We will use an AR(1) correlation structure.

  3. Inflammatory trachoma scores; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU) [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    Inflammatory trachoma grades will be modeled in the same way as Follicular Trachoma.

  4. Clinical trachoma improvement as measured in photography [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    We anticipate having the following information available. For each child in the sampling frame, we will have a binary improvement score, based on baseline and follow-up photography. We propose to conduct clustered logistic regression (taking into account the clustered nature of the design) using village assignment as the predictor. We will estimate the log odds of the treatment effect. Significance testing will be conducted at 0.05 based on Monte Carlo permutation testing.

  5. Chlamydial load, individual level analysis [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    Quantitative PCR results at the individual level will be modeled using standard procedures for semi-continuous variables.

  6. Ocular chlamydia; age-stratified (6-9, 10 and up for WUHA; 8-12 for TAITU) [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    Longitudinal analysis of ocular chlamydia in the age 6-9 group will be modeled at the village level. A similar analysis will consider the 10 and over segment of the population.

  7. Nasopharyngeal pneumococcal macrolide resistance [ Time Frame: 12, 24, 36, 84 months ]
    Using standard microbiological techniques, the lab will process the swabs using media selective for Streptococcus pneumoniae, and then test for antibiotic resistance. Nasopharyngeal macrolide resistance in age 0-5 will be modeled at the village level, using treatment arm as a covariate.

  8. Proportion of the population with clean faces at the village level [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    The proportion of the population with clean faces will be compared (at the village level) between the two groups, using ANCOVA with baseline values and treatment arm as covariates.

  9. Childhood growth (height) [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    Longitudinal analysis of anthropometric measurements between the two arms will be conducted using growth curve models.

  10. Childhood growth (weight) [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    Longitudinal analysis of anthropometric measurements between the two arms will be conducted using growth curve models.

  11. Soil-transmitted helminth prevalence [ Time Frame: 12, 24, 36 months ]
    The prevalence of soil transmitted helminths will be compared between the WUHA treatment arms in a linear mixed effects regression as described above for ocular chlamydia.

  12. Soil-transmitted helminth density [ Time Frame: 12, 24, 36 months ]
    Quantitative soil transmitted helminth results at the individual level will be modeled using standard procedures for semi-continuous variables.

  13. Prevalence of chlamydia and other antigen positivity from serological tests [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    The prevalence of chlamydia antigen positivity will be compared between the treatment arms in a linear mixed effects regression as described above for ocular chlamydia.

  14. Prevalence of stool-based antigen (diarrheal pathogens, soil transmitted helminths) positivity from serological tests [ Time Frame: 12, 24, 36, 48, 60, 72, 84 months ]
    The prevalence of soil transmitted helminths will be compared between the treatment arms in a linear mixed effects regression as described above for ocular chlamydia.

  15. Ancillary study: Intestinal microbiome from rectal sample [ Time Frame: 12 months ]
    Intestinal microbiome from rectal sample, using 16S rRNA deep sequencing and/or next generation sequencing

  16. Ancillary study: sensitivity and specificity of detecting STH using rectal swabs [ Time Frame: 12 months ]
    Sensitivity and specificity of detecting STH using rectal swabs with logistic mixed-effects. Bulk stool samples will be used as the gold standard.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754583


Contacts
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Contact: Dionna M Fry, MPH dionna.fry@ucsf.edu
Contact: Jeremy D Keenan, MD, MPH jeremy.keenan@ucsf.edu

Locations
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Ethiopia
The Carter Center Ethiopia Recruiting
Addis Ababa, Ethiopia
Contact: Zerihun Tadesse, MD    251-11-661-5980    zerihtad@yahoo.co.uk   
Sponsors and Collaborators
Francis I. Proctor Foundation
The Carter Center
Bahir Dar Regional Health and Research Laboratory
Emory University
National Eye Institute (NEI)
Investigators
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Study Director: Zerihun Tadese, MD, MPH The Carter Center Ethiopia
Principal Investigator: Jeremy D Keenan, MD, MPH University of California San Francisco Proctor Foundation
Study Director: Dionna M Fry, MPH UCSF Proctor Foundation

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Responsible Party: Jeremy Keenan, Associate Professor, Francis I. Proctor Foundation
ClinicalTrials.gov Identifier: NCT02754583     History of Changes
Other Study ID Numbers: 14-14004
U10EY023939 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeremy Keenan, Francis I. Proctor Foundation:
trachoma
soil transmitted helminths
sanitation
face washing
antibiotics
Additional relevant MeSH terms:
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Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Anti-Bacterial Agents
Tetracycline
Antibiotics, Antitubercular
Albendazole
Anti-Infective Agents
Antitubercular Agents
Anthelmintics
Antiparasitic Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Synthesis Inhibitors