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

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Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Quantitative PCR chlamydia load

Condition

Trachoma

Intervention

Water, sanitation, and hygiene (WASH) intervention

Study Arms / Comparison Groups

 WASH arm (WUHA)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

220000

Start Date

November 1, 2015

Completion Date

August 31, 2024

Primary Completion Date

January 31, 2024

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]
      

Gender

All

Ages

N/A - 120 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Zerihun Tadese, MD, MPH, , [email protected]

Location Countries

Ethiopia

Location Countries

Ethiopia

Administrative Informations


NCT ID

NCT02754583

Organization ID

14-14004

Secondary IDs

U10EY023939

Responsible Party

Principal Investigator

Study Sponsor

Francis I. Proctor Foundation

Collaborators

 The Carter Center

Study Sponsor

Zerihun Tadese, MD, MPH, Study Director, The Carter Center Ethiopia


Verification Date

May 2020