Ontology highlight
ABSTRACT: Trial design
Trachoma is targeted for global elimination. Infection rates with Chlamydia trachomatis are higher in new arrivals to a community and in travelers who leave for extended periods, suggesting they are sources of re-infection. This community-randomized, clinical trial was designed to determine if a surveillance program that targeted newcomers and travelers, identified weekly, would result in more communities achieving levels of infection of ?1%.Methods
52 communities were randomly allocated 1:1 to the control (annual MDA alone if warranted) or intervention arm (annual MDA if warranted, plus a surveillance program to identify and treat newcomers and travelers). In each community, surveys were completed every six months on a random sample of 100 children ages 1-9 years for trachoma and infection. The primary outcome was the proportion of communities in the intervention arm, compared to the control arm, which had a prevalence of infection at ?1% by 24 months. Registered: clinicaltrials.gov(NCT01767506).Results
Intervention communities experienced an average of 110 surveillance events per month. At 24 months, 7 (27%) of 26 intervention communities achieved a prevalence of infection ?1% compared to 4 (15%) of the 26 control communities (odds ratio = 2·6, 95%CI = 0·56-11·9). At 24 months, the average infection prevalence in the intervention communities was 4·8, compared to 6·9 in the control communities (p = ·06).Conclusion
Despite surveillance programs for community newcomers and travelers, the proportion of intervention communities with a level of infection ?1% was lower than expected and not significantly different from control communities.
SUBMITTER: West SK
PROVIDER: S-EPMC5490954 | biostudies-literature | 2017
REPOSITORIES: biostudies-literature
West Sheila K SK Munoz Beatriz B Mkocha Harran H Dize Laura L Gaydos Charlotte A CA Swenor Bonnie B Ervin Ann-Margret AM Quinn Thomas C TC
PloS one 20170629 6
<h4>Trial design</h4>Trachoma is targeted for global elimination. Infection rates with Chlamydia trachomatis are higher in new arrivals to a community and in travelers who leave for extended periods, suggesting they are sources of re-infection. This community-randomized, clinical trial was designed to determine if a surveillance program that targeted newcomers and travelers, identified weekly, would result in more communities achieving levels of infection of ≤1%.<h4>Methods</h4>52 communities we ...[more]