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

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ClinicalTrials.gov Identifier: NCT02754583
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : February 15, 2017
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 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.

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 4

Detailed Description:

Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Amhara region of Ethiopia for the past 10 years, through a series of clinical trials. We have found that repeated mass administration of oral azithromycin can greatly reduce the prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate infection.

The World Health Organization recommends not only antibiotics for control of trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial hygiene promotion, and Environmental improvements such as latrines and water points). The rationale for the SAFE strategy is based on many years of observational studies on trachoma. Cross-sectional studies have found that clinically active trachoma and ocular chlamydial infection are associated with several indicators of poor hygiene, including dirty faces, face-seeking flies, long distance to water supply, and lack of household latrine. There are few randomized trials testing the impact of WASH improvements on trachoma.

In the past, the WHO has recommended targeted antibiotic treatments to those individuals with active disease, so this could be an alternative treatment strategy that would limit antibiotic use in the community and perhaps be cost-saving. However, little research has assessed targeted treatments as a strategy for trachoma elimination following repeated mass azithromycin distributions.

Our long term goal is to eliminate trachoma even in the most hyperendemic communities. This cluster-randomized clinical trial will determine the role of a comprehensive package of sanitation measures for the elimination of trachoma. We will monitor clinical disease with photography, and monitor infection with a newer chlamydial polymerase chain reaction (PCR) test (Abbott m2000) that is more sensitive than earlier generation tests, and provides quantification. We will monitor other potential health benefits of a WASH intervention and test its overall cost effectiveness. We will also assess a competing strategy for minimizing antibiotic use: that of targeted azithromycin treatments to children testing positive for ocular chlamydia. We will model the long-term cost-effectiveness of these competing strategies for trachoma control after completion of several rounds of mass azithromycin distributions.

As an ancillary trial, we will examine whether albendazole and oral azithromiacin distribution alters the intestinal microbiome. We will also examine the validity of using rectal swabs versus bulk stool samples for measuring soil transmitted helminths (STHs). For this ancillary trial, the randomization unit is the person not the community.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sanitation, Water, and Instruction in Face-washing for Trachoma
Study Start Date : November 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: WASH arm
Behavioral: Water, sanitation, and hygiene (WASH) intervention: Communities will receive the water, sanitation, and hygiene (WASH) intervention including water point construction, hygiene and sanitation promotion, and educational materials.
Behavioral: Water, sanitation, and hygiene (WASH) intervention
WASH arm: Communities will receive the water, sanitation, and hygiene (WASH) intervention including water point construction, hygiene and sanitation promotion, and educational materials.
Other Name: WASH Upgrades for Health in Amhara (WUHA)

Standard of care WASH arm
Standard of care WASH intervention: Communities will continue to receive the standard of care WASH programming offered by the Ethiopian government. These communities will receive a WASH package at the conclusion of the 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

Experimental: Targeted antibiotics arm
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
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
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
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
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
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 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 months ]
  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 months ]
  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 months ]
  4. Ocular chlamydia; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU) [ Time Frame: 12, 24, 36 months ]
  5. Nasopharyngeal pneumococcal macrolide resistance [ Time Frame: 12, 24, 36 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.

  6. Proportion of the population with clean faces at the village level [ Time Frame: 12, 24, 36 months ]
  7. Childhood growth (height) [ Time Frame: 12, 24, 36 months ]
  8. Childhood growth (weight) [ Time Frame: 12, 24, 36 months ]
  9. Soil-transmitted helminth prevalence [ Time Frame: 12, 24, 36 months ]
  10. Soil-transmitted helminth density [ Time Frame: 12, 24, 36 months ]
  11. Prevalence of chlamydia and other antigen positivity from serological tests [ Time Frame: 12, 24, and 36 months ]
  12. Prevalence of stool-based antigen (diarrheal pathogens, soil transmitted helminths) positivity from serological tests [ Time Frame: 12, 24, and 36 months ]
  13. Ancillary study: Intestinal microbiome from rectal sample, using 16S rRNA deep sequencing and/or next generation sequencing [ Time Frame: 12 months ]
  14. Ancillary study: sensitivity and specificity of detecting STH using rectal swabs with logistic mixed-effects [ Time Frame: 12 months ]
    Bulk stool samples will be used as the gold standard



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Ages Eligible for Study:   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
  • Area within each school district that is in need of a well

Exclusion Criteria:

  • School districts that are too difficult to reach (more than a 3-hour walk from the farthest place reachable by a four-wheel drive vehicle)
  • School districts in the 2 urban regions of the study area
  • Refusal of village chief

Individual Level

Inclusion Criteria:

  • All residents residing near to the well sites that are randomly selected for this 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
Contact: Dionna M Fry, MPH dionna.fry@ucsf.edu
Contact: Jeremy D Keenan, MD, MPH jeremy.keenan@ucsf.edu

Locations
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
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

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: February 15, 2017
Last Verified: February 2017

Keywords provided by Jeremy Keenan, Francis I. Proctor Foundation:
trachoma
soil transmitted helminths
sanitation
face washing
antibiotics

Additional relevant MeSH terms:
Conjunctivitis, Bacterial
Conjunctivitis
Trachoma
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
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