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Study Title and Description

Efficacy of latrine promotion on emergence of infection with ocular Chlamydia trachomatis after mass antibiotic treatment: a cluster-randomized trial



Key Questions Addressed
1 What is the effect of environmental sanitary interventions for preventing active trachoma?
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Primary Publication Information
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TitleData
Title Efficacy of latrine promotion on emergence of infection with ocular Chlamydia trachomatis after mass antibiotic treatment: a cluster-randomized trial
Author Stoller NE, Gebre T, Ayele B, Zerihun M, Assefa Y, Habte D, et al
Country
Year 2011
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Environmental sanitary interventions for preventing active trachoma 2012
Arms
Number Title Description Comments
1 Fly control interventions Mass treatment with azithromycin or topical tetracycline. 12 communities were randomised to intensive latrine promotion.
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2 No intervention
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 75-84
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Methods Cluster-randomised trial of 24 communities in Ethiopia. A random selection of 60 children aged 0-9 years in each was monitored for clinical signs of trachoma and ocular chlamydial infection at baseline, 12 and 24 months
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Interventions Mass treatment with azithromycin or topical tetracycline. 12 communities were randomised to intensive latrine promotion
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Outcomes Active trachoma and ocular infection
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Notes
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Participants Children resident in trachoma endemic communities
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Recruitment bias:Authors' judgement Low risk
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Recruitment bias:Support for judgement The subkebeles were randomly selected and the children to be examined in each sentinel team were randomly selected at all measurement intervals
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Baseline imbalance:Authors' judgement Low risk
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Baseline imbalance:Support for judgement Random selection of subkebeles and children to be examined Baseline variables reported and were comparable except for antibiotics coverage which was higher in control arm Table 1 page 79
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Blinding of participants and personnel (performance bias)Active trachoma:Authors' judgement Unclear risk
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Blinding of participants and personnel (performance bias)Active trachoma:Support for judgement Latrine provision is difficult to mask but unclear the effect this would have had on the participants
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Blinding of participants and personnel (performance bias)Other outcomes:Authors' judgement Unclear risk
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Blinding of participants and personnel (performance bias)Other outcomes:Support for judgement Latrine provision is difficult to mask but unclear the effect this would have had on the participants
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Blinding of outcome assessment (detection bias)Active trachoma:Authors' judgement Unclear risk
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Blinding of outcome assessment (detection bias)Active trachoma:Support for judgement For clinical trachoma grading assessors could not be effectively masked. Outcome assessors were from outside the area
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Blinding of outcome assessment (detection bias)Other outcomes:Authors' judgement Low risk
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Blinding of outcome assessment (detection bias)Other outcomes:Support for judgement For the primary outcome measure – ocular chlamydial infection using PCR, the assessors in the lab were masked
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Incomplete outcome data (attrition bias):Authors' judgement Low risk
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Incomplete outcome data (attrition bias):Support for judgement A random sample of 60 participants sampled from each community at each time point
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Selective reporting (reporting bias):Authors' judgement Low risk
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Selective reporting (reporting bias):Support for judgement Relevant outcomes reported. Authors have reported all outcomes measures they assessed
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Study design Cluster randomized trial
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Unit of analysis Individual
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Number randomly assigned 60 children randomly selected from each of 24 communities at each time point: 720 azithromycine, 720 topical tetracycline; 12 communities randomly assigned to intensive latrine promotion
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Losses to follow-up None
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Number analyzed 60 children from each of 24 communities (1440 children)
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Country Ethiopia
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Age of participants 0 - 9 years
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Equivalence of baseline characteristics Baseline variables reported and were comparable except for antibiotics coverage which was higher in control arm
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Intervention 1 Mass treatment with azithromycin
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Intervention 2 Mass treatment with topical tetracycline
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Length of follow up 2 years
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Primary outcome, as defined in study report Active trachoma
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Secondary outcome(s), as defined in study report ocular infection
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Times at which outcome(s) are assessed Baseline, 12 months, and 24 months
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Intervention 3 Intensive latrine promotion
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Results & Comparisons


Results Data
Outcome: Number of participants with TF or TI      Population: All Participants Between-Arm Comparisons
Time Point Measure Fly control interventions No intervention Comparison Measure Fly control interventions vs. No intervention


12 months

N Analyzed 720 720 Risk Difference (RD)
Counts P-Value > 0.05


24 months

N Analyzed 720 720 Risk Difference (RD)
Counts P-Value > 0.05
Outcome: Latrine utilisation      Population: All Participants
Time Point Measure Fly control interventions No intervention


12 months

N Analyzed 720 720
Counts 80.8% 30.0%


24 months

N Analyzed 720 720
Counts 61.7% 25.0%

Adverse Events
Arm or Total Title Description Comments