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Clinical Trials |

Can We Stop Mass Drug Administration Prior to 3 Annual Rounds in Communities With Low Prevalence of Trachoma?  PRET Ziada Trial Results

Jithin Yohannan, BA; Beatriz Munoz, MS; Harran Mkocha, BS; Charlotte A. Gaydos, PhD; Robin Bailey, MD, PhD; Thomas A. Lietman, MD; Thomas Quinn, MD; Sheila K. West, PhD
JAMA Ophthalmol. 2013;131(4):431-436. doi:10.1001/jamaophthalmol.2013.2356.
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Importance The World Health Organization recommends at least 3 annual mass drug administrations (MDAs) of azithromycin in places where the prevalence of follicular trachoma (FT) is greater than 10%. However, stopping MDA prior to 3 rounds, if monitoring indicates an absence of infection with Chlamydia trachomatis even if FT persists, may be more cost-effective.

Objective To determine the prevalence of infection in communities randomized to 3 rounds of annual MDAs with azithromycin compared with communities randomized to a stopping rule, where MDA could cease if the infection rate was low.

Design A 1:1 community randomized trial comparing usual care with a cessation rule. The Partnership for the Rapid Elimination of Trachoma–Ziada Trial was conducted from February 1, 2010, through September 1, 2011.

Setting Sixteen communities in Tanzania with trachoma prevalence rates between 10% and 20%.

Participants A total of 100 children aged 5 years or younger randomly drawn from each community. Children had to reside in an eligible community, have no ocular condition that prevented trachoma grading or ocular specimen collection, and have a guardian who could provide consent for participation.

Interventions Cessation of MDA with azithromycin if the community had no infection in their sample at 6 months or 18 months.

Main Outcome Measure The prevalence of C trachomatis at 18 months.

Results None of the intervention communities met criteria to stop MDA based on the 6-month or 18-month survey; all, as well as the usual care communities, were scheduled for a third MDA round. There was no difference in infection (2.9% vs 4.7%; P = .25) between the usual care and cessation rule communities at 18 months.

Conclusions and Relevance In this setting, communities with low (10%-20%) initial prevalence of active trachoma did not have MDA stopped before 3 annual rounds on the basis of monitoring for infection. Infection with C trachomatis in communities with average trachoma rates at 12% to 13% cannot be eliminated before 3 rounds of MDA with azithromycin.

Trial Registration clinicaltrials.gov Identifier: NCT00792922.

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Figure 1. Consort diagram of the design and characteristics of the Partnership for the Rapid Elimination of Trachoma–Ziada Trial. The usual care arm received 3 rounds of MDAs, while the cessation rule group received MDA at baseline and thereafter only if infection prevalence was greater than 0% at the 6-month or 18-month follow-up visit.

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Figure 2. Graphs indicating infection/disease rates in villages over time. A, Graph shows the prevalence of Chlamydiatrachomatis infection over time in the usual care and cessation rule arms. The dashed lines indicate the mean prevalence in each arm, and the thin lines indicate community-level prevalence. B, Graph shows the prevalence of follicular trachoma over time in the usual care and cessation rule arms. The dashed lines indicate the mean prevalence in each arm, and the thin lines indicate community-level prevalence.

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