TrachomaPhase 3SWIFT I/IINCT02754583
Sanitation, Water, and Instruction in Face-washing for Trachoma I/II
A Phase 3 study testing Water, sanitation, and hygiene (WASH) intervention, Azithromycin and Tetracycline in people with Trachoma, run by University of California, San Francisco at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Trachoma
- What is being tested?
- Water, sanitation, and hygiene (WASH) intervention, Azithromycin and Tetracycline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47,605 participants
- Where
- 1 siteEthiopia
- Study dates
- 5 Dec 2015to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
- Refusal of participant [or parent/guardian]
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Trachoma
- Being tested
- Water, sanitation, and hygiene (WASH) intervention, Standard of care WASH intervention, Azithromycin, Tetracycline, Control
- Keywords
- trachoma, soil transmitted helminths, sanitation, face washing, antibiotics
- Medical subject headings
- Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water, sanitation, and hygiene (WASH) interventionBehavioural
Also called WASH Upgrades for Health in Amhara (WUHA)
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.
Standard of care WASH interventionBehavioural
Also called WUHA
Stand of care WASH arm
AzithromycinDrug
20mg/kg
TetracyclineDrug
Tetracycline will be administered in lieu of azithromycin if individual is under 6 months, has a known azithromycin allergy, or is severely ill.
ControlOther
The control group will receive no intervention during the trial. They will be enrolled in mass antibiotic treatment at the conclusion of the trial.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Azithromycin; Drug: Tetracycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months for TAITU, 36 months for WUHA
Secondary outcomes (16)
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.
Measured: 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)
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.
Measured: 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)
Inflammatory trachoma grades will be modeled in the same way as Follicular Trachoma.
Measured: 12, 24, 36, 48, 60, 84, 96 months
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.
Measured: 12, 24, 36, 48, 60, 84, 96 months
Chlamydial load, individual level analysis
Quantitative PCR results at the individual level will be modeled using standard procedures for semi-continuous variables.
Measured: 12, 24, 36, 48, 60, 84, 96 months
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.
Measured: 12, 24, 36, 48, 60, 84, 96 months
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.
Measured: 0, 36, 96 months
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.
Measured: 12, 24, 36, 48, 60, 84, 96 months
Childhood growth (height)
Longitudinal analysis of anthropometric measurements between the two arms will be conducted using growth curve models.
Measured: 12, 24, 36 months
Childhood growth (weight)
Longitudinal analysis of anthropometric measurements between the two arms will be conducted using growth curve models.
Measured: 12, 24, 36 months
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.
Measured: 12, 24, 36 months
Soil-transmitted helminth density
Quantitative soil transmitted helminth results at the individual level will be modeled using standard procedures for semi-continuous variables.
Measured: 12, 24, 36 months
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.
Measured: 12, 24, 36, 48, 60, 84, 96 months
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.
Measured: 12, 24, 36, 48, 60, 84, 96 months
Intestinal microbiome from rectal sample
Intestinal microbiome from rectal sample, using 16S rRNA deep sequencing and/or next generation sequencing
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start5 Dec 2015
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TrachomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47,605 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- The Carter Center, Amhara Public Health Institute, Emory University, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Zerihun Tadese, MD, MPH, Study director, The Carter Center EthiopiaJeremy D Keenan, MD, MPH, Principal investigator, University of California San Francisco Proctor FoundationDionna M Wittberg, MPH, Study director, UCSF Proctor Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754583
- Sponsor's protocol ID
- 14-14004
- Other IDs
- U10EY023939
- Acronym
- SWIFT I/II
- Status last verified
- Jun 2026
- First submitted
- 15 Oct 2015
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41548574Frank 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.
PubMed 41314021Caleon 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.
PubMed 38991011Tedijanto 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.
PubMed 38134305Aragie 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.
PubMed 34919861Wittberg 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.
PubMed 33619183
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sanitation, Water, and Instruction in Face-washing for Trachoma I/II
- ClinicalTrials.gov ID
- NCT02754583
- Acronym / sponsor ID
- SWIFT I/II / 14-14004
- Conditions
- Trachoma
- Keywords
- trachoma, soil transmitted helminths, sanitation, face washing, antibiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47,605 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- The Carter Center, Amhara Public Health Institute, Emory University, National Eye Institute (NEI)
- Study start
- 5 Dec 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| WASH arm (WUHA) | Experimental | Behavioral: Water, sanitation, and hygiene (WASH) intervention, Drug: Azithromycin, Drug: TetracyclineWUHA 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. |
| Standard of care WASH arm (WUHA) | Other | Behavioral: Standard of care WASH intervention, Drug: Azithromycin, Drug: TetracyclineWUHA 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 antibiotics arm (TAITU) | Experimental | Drug: Azithromycin, Drug: TetracyclineTargeted 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 antibiotics arm (TAITU) | Other | Other: ControlDelayed 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 antibiotics arm (TAITU) | Active comparator | Drug: Azithromycin, Drug: TetracyclineMass 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. |
Who may qualify
- Ages
- 1 day to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
- Individual Level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water, sanitation, and hygiene (WASH) interventionAlso: WASH Upgrades for Health in Amhara (WUHA)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. | Behavioural | WASH arm (WUHA) |
| Standard of care WASH interventionAlso: WUHAStand of care WASH arm | Behavioural | Standard of care WASH arm (WUHA) |
| Azithromycin20mg/kg | Drug | Mass antibiotics arm (TAITU), Standard of care WASH arm (WUHA), Targeted antibiotics arm (TAITU), WASH arm (WUHA) |
| TetracyclineTetracycline will be administered in lieu of azithromycin if individual is under 6 months, has a known azithromycin allergy, or is severely ill. | Drug | Mass antibiotics arm (TAITU), Standard of care WASH arm (WUHA), Targeted antibiotics arm (TAITU), WASH arm (WUHA) |
| ControlThe control group will receive no intervention during the trial. They will be enrolled in mass antibiotic treatment at the conclusion of the trial. | Other | Delayed mass antibiotics arm (TAITU) |
Primary outcome
Village-specific ocular chlamydia among 0-5 children over time (first trial: WUHA)
Time frame: 12, 24, 36, 48, 60, 84, 96 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.
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.
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.
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.
16 secondary outcomes
Quantitative PCR chlamydia load
Time frame: 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)
Time frame: 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)
Time frame: 12, 24, 36, 48, 60, 84, 96 months
Clinical trachoma improvement as measured in photography
Time frame: 12, 24, 36, 48, 60, 84, 96 months
Chlamydial load, individual level analysis
Time frame: 12, 24, 36, 48, 60, 84, 96 months
Ocular chlamydia; age-stratified (6-9, 10 and up for WUHA; 8-12 for TAITU)
Time frame: 12, 24, 36, 48, 60, 84, 96 months
Nasopharyngeal pneumococcal macrolide resistance
Time frame: 0, 36, 96 months
Proportion of the population with clean faces at the village level
Time frame: 12, 24, 36, 48, 60, 84, 96 months
Childhood growth (height)
Time frame: 12, 24, 36 months
Childhood growth (weight)
Time frame: 12, 24, 36 months
Soil-transmitted helminth prevalence
Time frame: 12, 24, 36 months
Soil-transmitted helminth density
Time frame: 12, 24, 36 months
Prevalence of chlamydia and other antigen positivity from serological tests
Time frame: 12, 24, 36, 48, 60, 84, 96 months
Prevalence of stool-based antigen (diarrheal pathogens, soil transmitted helminths) positivity from serological tests
Time frame: 12, 24, 36, 48, 60, 84, 96 months
Intestinal microbiome from rectal sample
Time frame: 24 months
Sensitivity and specificity of detecting STH using rectal swabs
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 41548574Wittberg 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.
- Derived from this study: PubMed 41314021Frank 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.
- Derived from this study: PubMed 38991011Caleon 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.
- Derived from this study: PubMed 38134305Tedijanto 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.
- Derived from this study: PubMed 34919861Aragie 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.
- Derived from this study: PubMed 33619183Wittberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zerihun Tadese, MD, MPH study director
The Carter Center Ethiopia
Jeremy D Keenan, MD, MPH principal investigator
University of California San Francisco Proctor Foundation
Dionna M Wittberg, MPH study director
UCSF Proctor Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Water, sanitation, and hygiene (WASH) intervention, Azithromycin and Tetracycline in people with Trachoma, run by University of California, San Francisco at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Village-specific ocular chlamydia among 0-5 children over time (first trial: WUHA) (time frame: 12, 24, 36, 48, 60, 84, 96 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754583, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.