Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II).
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 azi...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2018-08-01
|
| Series: | PLoS Medicine |
| Online Access: | http://europepmc.org/articles/PMC6091918?pdf=render |
| _version_ | 1819042034558697472 |
|---|---|
| author | Jeremy D Keenan Zerihun Tadesse Sintayehu Gebresillasie Ayalew Shiferaw Mulat Zerihun Paul M Emerson Kelly Callahan Sun Y Cotter Nicole E Stoller Travis C Porco Catherine E Oldenburg Thomas M Lietman |
| author_facet | Jeremy D Keenan Zerihun Tadesse Sintayehu Gebresillasie Ayalew Shiferaw Mulat Zerihun Paul M Emerson Kelly Callahan Sun Y Cotter Nicole E Stoller Travis C Porco Catherine E Oldenburg Thomas M Lietman |
| author_sort | Jeremy D Keenan |
| collection | DOAJ |
| 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). |
| first_indexed | 2024-12-21T09:34:28Z |
| format | Article |
| id | doaj.art-17253aa89a6840cc9176a5d3788a3e17 |
| institution | Directory Open Access Journal |
| issn | 1549-1277 1549-1676 |
| language | English |
| last_indexed | 2024-12-21T09:34:28Z |
| publishDate | 2018-08-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Medicine |
| spelling | doaj.art-17253aa89a6840cc9176a5d3788a3e172022-12-21T19:08:40ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762018-08-01158e100263310.1371/journal.pmed.1002633Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II).Jeremy D KeenanZerihun TadesseSintayehu GebresillasieAyalew ShiferawMulat ZerihunPaul M EmersonKelly CallahanSun Y CotterNicole E StollerTravis C PorcoCatherine E OldenburgThomas M LietmanBACKGROUND: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).http://europepmc.org/articles/PMC6091918?pdf=render |
| spellingShingle | Jeremy D Keenan Zerihun Tadesse Sintayehu Gebresillasie Ayalew Shiferaw Mulat Zerihun Paul M Emerson Kelly Callahan Sun Y Cotter Nicole E Stoller Travis C Porco Catherine E Oldenburg Thomas M Lietman Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II). PLoS Medicine |
| title | Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II). |
| title_full | Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II). |
| title_fullStr | Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II). |
| title_full_unstemmed | Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II). |
| title_short | Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II). |
| title_sort | mass azithromycin distribution for hyperendemic trachoma following a cluster randomized trial a continuation study of randomly reassigned subclusters tana ii |
| url | http://europepmc.org/articles/PMC6091918?pdf=render |
| work_keys_str_mv | AT jeremydkeenan massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT zerihuntadesse massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT sintayehugebresillasie massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT ayalewshiferaw massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT mulatzerihun massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT paulmemerson massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT kellycallahan massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT sunycotter massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT nicoleestoller massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT traviscporco massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT catherineeoldenburg massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii AT thomasmlietman massazithromycindistributionforhyperendemictrachomafollowingaclusterrandomizedtrialacontinuationstudyofrandomlyreassignedsubclusterstanaii |