Dataset Information

Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma.

ABSTRACT:

Background

The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation-follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines.

Methods

The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission.

Discussion

The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. TRIAL REGISTRATION NUMBER: This study is registered at clinicaltrials.gov ( NCT04185402 ). Registered December 4, 2019; prospectively registered pre-results.

SUBMITTER: Amza A

PROVIDER: S-EPMC7789605 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma.

Amza Abdou A Kadri Boubacar B Nassirou Beido B Arzika Ahmed M AM Austin Ariana A Nyatigo Fanice F Lebas Elodie E Arnold Benjamin F BF Lietman Thomas M TM Oldenburg Catherine E CE

BMC ophthalmology 20210106 1

<h4>Background</h4>The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation-follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether ...[more]

PMID: 33407263

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Project description:BACKGROUND:The World Health Organization recommends annual mass azithromycin administration in communities with at least 10% prevalence of trachomatous inflammation-follicular (TF) in children, with further treatment depending on reassessment after 3-5 years. However, the effect of stopping mass azithromycin distribution after multiple rounds of treatment is not well understood. Here, we report the results of a cluster-randomized trial where communities that had received 4 years of treatments were then randomized to continuation or discontinuation of treatment. METHODS AND FINDINGS:In all, 48 communities with 3,938 children aged 0-9 years at baseline in northern Ethiopia had received 4 years of annual or twice yearly mass azithromycin distribution as part of the TANA I trial. We randomized these communities to either continuation or discontinuation of treatment. Individuals in the communities in the continuation arm were offered either annual or twice yearly distribution of a single directly observed dose of oral azithromycin. The primary outcome was community prevalence of ocular chlamydial infection in a random sample of children aged 0-9 years, 36 months after baseline. We also assessed the change from baseline to 36 months in ocular chlamydia prevalence within each arm. We compared 36-month ocular chlamydia prevalence in communities randomized to continuation versus discontinuation in a model adjusting for baseline ocular chlamydia prevalence. A secondary prespecified analysis assessed the rate of change over time in ocular chlamydia prevalence between arms. In the continuation arm, mean antibiotic coverage was greater than 90% at all time points. In the discontinuation arm, the mean prevalence of infection in children aged 0-9 years increased from 8.3% (95% CI 4.2% to 12.4%) at 0 months to 14.7% (95% CI 8.7% to 20.8%, P = 0.04) at 36 months. Ocular chlamydia prevalence in communities where mass azithromycin distribution was continued was 7.2% (95% CI 3.3% to 11.0%) at baseline and 6.6% (95% CI 1.1% to 12.0%, P = 0.64) at 36 months. The 36-month prevalence of ocular chlamydia was significantly lower in communities continuing treatment compared with those discontinuing treatment (P = 0.03). Limitations of the study include uncertain generalizability outside of trachoma hyperendemic regions. CONCLUSIONS:In this study, ocular chlamydia infection rebounded after 4 years of periodic mass azithromycin distribution. Continued distributions did not completely eliminate infection in all communities or meet WHO control goals, although they did prevent resurgence. TRIAL REGISTRATION:This study was prospectively registered at clinicaltrials.gov (clinicaltrials.gov NCT01202331).

Project description:BackgroundMass drug administration with antibiotics predominantly with azithromycin is one of the four arms of the SAFE strategy. The elimination of ocular chlamydial infection is only achieved as long as the azithromycin mass treatments (AMT) are given frequently enough and at a high enough coverage. This study was conducted to assess the coverage of azithromycin mass treatment and its determinants in Awi Zone, Northwestern Ethiopia.MethodsHouse to house survey using a structured questionnaire was done between July 7 to July 25, 2013. Coverage is defined as the proportion of individuals in the eligible population who actually ingested the Azithromycin during the Campaign.ResultsA total of 1267 households were enrolled in the survey in which 5826 eligible members were living in these households. Almost half (54.6%) of the community members who were eligible for all six campaigns had participated in more than three campaigns of azithromycin mass treatment. The overall average self-reported coverage of the azithromycin mass treatment (AMT) in all six campaigns was 62.8% (64% in rural vs. 61.6% urban). On average, each eligible person had taken the drug 3.77 times. The rural residents were significantly more likely to have received treatment during the last round of AMT in 2012 {AOR?=?2.35; 95% CI [1.80-3.06]}. Azithromycin uptake status of female household heads was less than the corresponding male household heads {AOR?=?0.41; 95% CI [0.24-0.72]}. Household heads' awareness about trachoma (AOR?=?2.55; 95% CI [1.19-5.44]) and AMT {AOR?=?7.19; 95% CI [3.27-15.82]} had positive association with acceptability.ConclusionThe overall average AMT coverage was found to be low. There was low coverage of the treatment in the urban community as compared to the rural residents. Misconceptions of household heads about trachoma and azithromycin have negatively affected the coverage. Further work on why female household heads are associated with higher risk of non-participation in AMT is warranted. Strengthening awareness creation and consideration of additional campaigns is essential.

Dataset Information

Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma.

Background

Methods

Discussion

Publications

Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma.

Similar Datasets

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