search
Back to results

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

Primary Purpose

Trachoma

Status
Recruiting
Phase
Phase 3
Locations
Ethiopia
Study Type
Interventional
Intervention
Water, sanitation, and hygiene (WASH) intervention
Standard of care WASH intervention
Azithromycin
Tetracycline
Control
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trachoma focused on measuring trachoma, soil transmitted helminths, sanitation, face washing, antibiotics

Eligibility Criteria

1 Day - 120 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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]

Sites / Locations

  • The Carter Center EthiopiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Other

Experimental

Other

Active Comparator

Arm Label

WASH arm (WUHA)

Standard of care WASH arm (WUHA)

Targeted antibiotics arm (TAITU)

Delayed mass antibiotics arm (TAITU)

Mass antibiotics arm (TAITU)

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Quantitative PCR chlamydia load
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.
Follicular trachoma scores; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU)
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.
Inflammatory trachoma scores; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU)
Inflammatory trachoma grades will be modeled in the same way as Follicular Trachoma.
Clinical trachoma improvement as measured in photography
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.
Chlamydial load, individual level analysis
Quantitative PCR results at the individual level will be modeled using standard procedures for semi-continuous variables.
Ocular chlamydia; age-stratified (6-9, 10 and up for WUHA; 8-12 for TAITU)
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.
Nasopharyngeal pneumococcal macrolide resistance
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.
Proportion of the population with clean faces at the village level
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.
Childhood growth (height)
Longitudinal analysis of anthropometric measurements between the two arms will be conducted using growth curve models.
Childhood growth (weight)
Longitudinal analysis of anthropometric measurements between the two arms will be conducted using growth curve models.
Soil-transmitted helminth prevalence
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.
Soil-transmitted helminth density
Quantitative soil transmitted helminth results at the individual level will be modeled using standard procedures for semi-continuous variables.
Prevalence of chlamydia and other antigen positivity from serological tests
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.
Prevalence of stool-based antigen (diarrheal pathogens, soil transmitted helminths) positivity from serological tests
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.
Intestinal microbiome from rectal sample
Intestinal microbiome from rectal sample, using 16S rRNA deep sequencing and/or next generation sequencing
Sensitivity and specificity of detecting STH using rectal swabs
Sensitivity and specificity of detecting STH using rectal swabs with logistic mixed-effects. Bulk stool samples will be used as the gold standard.

Full Information

First Posted
October 15, 2015
Last Updated
August 16, 2023
Sponsor
University of California, San Francisco
Collaborators
The Carter Center, Amhara Public Health Institute, Emory University, National Eye Institute (NEI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02754583
Brief Title
Sanitation, Water, and Instruction in Face-washing for Trachoma I/II
Acronym
SWIFT I/II
Official Title
Sanitation, Water, and Instruction in Face-washing for Trachoma I/II
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2015 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
The Carter Center, Amhara Public Health Institute, Emory University, National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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. Our monitoring has revealed a high uptake of the SWIFT I/WUHA I intervention as well as evidence of subsequent hygiene behavior changes. However, communities started out with a high burden of ocular chlamydia and preliminary data suggests that elimination will be unlikely. We therefore were granted an continuation grant (SWIFT II) to determine the long-term benefit of WASH for trachoma when combined with antibiotics, and second, to explore possibilities for low-cost, highly accurate point-of-care test for chlamydia. With SWIFT II, we are extending the WUHA I trial by performing a single mass azithromycin distribution in all 40 communities after the final study visit (i.e., month 36), and continuing the WASH intervention in the 20 communities originally randomized to WASH. We are monitoring for ocular chlamydia via PCR of conjunctival swabs. We ask whether antibiotic distributions combined with a comprehensive, well-functioning WASH package is more likely to eliminate trachoma than antibiotics alone. We will also collect extra swabs and dried blood spots during routine monitoring visits and compare several inexpensive, commercially available NAATs and serologic tests for chlamydia. The SWIFT II trial leverages our existing SWIFT I research infrastructure and takes advantage of the fact that the intervention has already been implemented, and will have been operating for more than six years by the end of the proposed study. WASH interventions are thought to take a long time to work given their reliance on changing behavior, and thus we will increase the chances of finding an effect if one truly exists. Moreover, we will advance knowledge regarding trachoma surveillance, which has become increasingly important as the world moves towards global elimination. The results of the SWIFT II study will be of interest to the trachoma community, and regardless of the outcome will directly help trachoma programs decide how to spend their limited resources.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma
Keywords
trachoma, soil transmitted helminths, sanitation, face washing, antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
340000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WASH arm (WUHA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care WASH arm (WUHA)
Arm Type
Other
Arm Description
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.
Arm Title
Targeted antibiotics arm (TAITU)
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed mass antibiotics arm (TAITU)
Arm Type
Other
Arm Description
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.
Arm Title
Mass antibiotics arm (TAITU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Water, sanitation, and hygiene (WASH) intervention
Other Intervention Name(s)
WASH Upgrades for Health in Amhara (WUHA)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care WASH intervention
Other Intervention Name(s)
WUHA
Intervention Description
Stand of care WASH arm
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
20mg/kg
Intervention Type
Drug
Intervention Name(s)
Tetracycline
Intervention Description
Tetracycline will be administered in lieu of azithromycin if individual is under 6 months, has a known azithromycin allergy, or is severely ill.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control group will receive no intervention during the trial. They will be enrolled in mass antibiotic treatment at the conclusion of the trial.
Primary Outcome Measure Information:
Title
Village-specific ocular chlamydia among 0-5 children over time (first trial: WUHA)
Description
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.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Ocular chlamydia among 8-12 year olds (second trial: TAITU-A)
Description
Cluster-specific prevalence of ocular chlamydia among individuals aged 8-12 years, compared between the targeted azithromycin arm and the mass azithromycin arm.
Time Frame
24 months
Title
Incident ocular chlamydia in 0-5 year-olds (third trial: TAITU-B)
Description
Incidence of new ocular chlamydia infection in 0-5 year-olds, compared between the targeted azithromycin arm and the delayed mass azithromycin arm.
Time Frame
24 months
Title
Trial-based cost-effectiveness of intervention (intervention costs per percent of chlamydia reduction)
Description
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.
Time Frame
24 months for TAITU, 36 months for WUHA
Secondary Outcome Measure Information:
Title
Quantitative PCR chlamydia load
Description
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.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Follicular trachoma scores; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU)
Description
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.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Inflammatory trachoma scores; age-stratified (0-5, 6-9, 10 and up for WUHA; 0-5, 8-12 for TAITU)
Description
Inflammatory trachoma grades will be modeled in the same way as Follicular Trachoma.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Clinical trachoma improvement as measured in photography
Description
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.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Chlamydial load, individual level analysis
Description
Quantitative PCR results at the individual level will be modeled using standard procedures for semi-continuous variables.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Ocular chlamydia; age-stratified (6-9, 10 and up for WUHA; 8-12 for TAITU)
Description
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.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Nasopharyngeal pneumococcal macrolide resistance
Description
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.
Time Frame
12, 24, 36, 84 months
Title
Proportion of the population with clean faces at the village level
Description
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.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Childhood growth (height)
Description
Longitudinal analysis of anthropometric measurements between the two arms will be conducted using growth curve models.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Childhood growth (weight)
Description
Longitudinal analysis of anthropometric measurements between the two arms will be conducted using growth curve models.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Soil-transmitted helminth prevalence
Description
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.
Time Frame
12, 24, 36 months
Title
Soil-transmitted helminth density
Description
Quantitative soil transmitted helminth results at the individual level will be modeled using standard procedures for semi-continuous variables.
Time Frame
12, 24, 36 months
Title
Prevalence of chlamydia and other antigen positivity from serological tests
Description
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.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Prevalence of stool-based antigen (diarrheal pathogens, soil transmitted helminths) positivity from serological tests
Description
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.
Time Frame
12, 24, 36, 48, 60, 72, 84 months
Title
Intestinal microbiome from rectal sample
Description
Intestinal microbiome from rectal sample, using 16S rRNA deep sequencing and/or next generation sequencing
Time Frame
24 months
Title
Sensitivity and specificity of detecting STH using rectal swabs
Description
Sensitivity and specificity of detecting STH using rectal swabs with logistic mixed-effects. Bulk stool samples will be used as the gold standard.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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]
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dionna M Wittberg, MPH
Email
dionna.wittberg@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy D Keenan, MD, MPH
Email
jeremy.keenan@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zerihun Tadese, MD, MPH
Organizational Affiliation
The Carter Center Ethiopia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeremy D Keenan, MD, MPH
Organizational Affiliation
University of California San Francisco Proctor Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dionna M Wittberg, MPH
Organizational Affiliation
UCSF Proctor Foundation
Official's Role
Study Director
Facility Information:
Facility Name
The Carter Center Ethiopia
City
Addis Ababa
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zerihun Tadesse, MD
Phone
251-11-661-5980
Email
zerihtad@yahoo.co.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
34919861
Citation
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.
Results Reference
derived
PubMed Identifier
33619183
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs