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Study Title and Description

Impact of face-washing on trachoma in Kongwa, Tanzania.



Key Questions Addressed
1 What is the effect of face washing promotion for preventing active trachoma?
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Primary Publication Information
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TitleData
Title Impact of face-washing on trachoma in Kongwa, Tanzania.
Author West S., Muñoz B., Lynch M., Kayongoya A., Chilangwa Z., Mmbaga BB., Taylor HR.
Country Dana Center for Preventive Ophthalmology, Johns Hopkins University, Baltimore, Maryland.
Year 1995
Numbers Pubmed ID: 7823670

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


Extraction Form: Face washing promotion for preventing active trachoma 2015
Arms
Number Title Description Comments
1 Tetracycline ointment + Face washing 30-day mass treatment campaign with topical tetracycline ointment once daily followed by intensive 1-month community-based participatory hygiene intervention, including neighborhood meetings and several reinforcement activities to improve face washing of the young children, during and after mass treatment.
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2 Tetracycline ointment 30-day mass treatment campaign with topical tetracycline ointment once daily alone.
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 155-8
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Study design cluster-RCT
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Number randomized 6 villages (1417 children); villages paired so that one village was assigned to the intervention and the other assigned to control;
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Exclusions after randomization none reported
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Unit of analysis villages (overall and by pairs)
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Number analyzed 6 villages
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Losses to follow-up 113 children (8% of 1417); "reasons for loss to follow-up were that the child died (2%) or that the family moved out of the village or out of the study area (6%)"
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How was missing data handled? not reported
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Reported power calculation none
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Unusual study design pairs of villages matched for baseline characteristics; "We randomized three pairs of villages-one of each pair would receive mass treatment followed by the health education campaign, and the other would receive mass treatment alone. The pairs of villages were matched for maternal education (years of formal education), baseline prevalence of clean faces in young children, and trachoma status (based on clinical observation at enrolment). Within each village, a complete census was taken by trained field-workers. 250 eligible households containing at least 1 child aged 1-7 years were randomly selected in each village. Within the household, 1 child was randomly selected to take part in the study."
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Country Kongwa, Tanzania
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Age 1 to 7 years
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Gender boys and girls
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Inclusion criteria for community
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Inclusion criteria for children
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Exclusion criteria for community
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Equivalence of baseline characteristics no; pairs of villages were matched for maternal education, and baseline prevalence of clean faces in young children, and trachoma status based on clinical observation at enrolment; however, the prevalence of trachoma may have been higher in the intervention villages based on photographic evidence of trachoma
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Intervention 1 30-day mass treatment campaign with topical tetracycline ointment once daily followed by intensive 1-month community-based participatory hygiene intervention, including neighborhood meetings and several reinforcement activities to improve face washing of the young children, during and after mass treatment
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Intervention 2 30-day mass treatment campaign with topical tetracycline ointment once daily alone
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Intervention 3
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Intervention 4
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Length of follow-up Planned: 12 months; Actual: 12 months
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Primary outcome, as defined in trial reports
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Secondary outcomes, as defined in trial reports
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Adverse events not reported
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Intervals at which outcomes assessed baseline, month 2 (1 month after the end of the mass treatment campaign), 6 and 12 months
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Type of study published
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Funding sources "This work was supported by the Edna McDonnell Clark Foundation and the Central Eye Health Foundation."
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Disclosures of interest one author (Dr. Sheila West) is a Research to Prevent Blindness senior scientific investigator
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Study period not reported
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Reported subgroup analyses yes (trachoma status at baseline and prevalence of clean faces at baseline, 2 months, 6 months and 12 months)
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Trial investigators contacted? yes; trial investigator contacted and provided information for previous versions of this review
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Pair 1 178 children in intervention village and 231 in control village;
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Pair 2 248 children in intervention village and 247 in control village;
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Pair 3 254 children in intervention village and 259 in control village;
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Total 680 children in intervention group and 737 in control group
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Inclusion criteria 1) children aged 1 to 7 years in the area where trachoma was endemic; 2) face washing campaign could be carried out at village level; 3) households containing at least 1 child
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Exclusion criteria none reported
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Outcomes, as defined in trial reports facial cleanliness based on the presence or absence of nasal discharge, ocular discharge, and flies on the face; trachoma status evaluated by photographs of the right eye of each index child graded on the WHO simplified grading scheme
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Random sequence generation (selection bias):Authors' judgement Unclear risk
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Random sequence generation (selection bias):Support for judgement Method of randomization not reported.
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Allocation concealment (selection bias):Authors' judgement Unclear risk
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Allocation concealment (selection bias):Support for judgement Allocation concealment not reported.
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Masking outcome assessors:Authors' judgement Low risk
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Masking outcome assessors:Support for judgement "Records of facial cleanliness were made by trained observers who were not part of the hygiene intervention team." "At each time, the tarsal plate of the right eye of each index child was photographed. The photographs were graded on the WHO simplified grading scheme by one examiner who was unaware of the randomization status of the village and the time of the photograph."
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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 "92% were followed up for 1 year. The main reasons for loss to follow-up were that the child died (2%) or that the family moved out of the village or out of the study area (6%)."
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Selective reporting (reporting bias):Authors' judgement Unclear risk
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Selective reporting (reporting bias):Support for judgement No protocol available.
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Other bias:Authors' judgement Low risk
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Other bias:Support for judgement No other sources of bias identified.
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Results & Comparisons


Results Data
Outcome: Number of participants with active trachoma      Population: All Participants Between-Arm Comparisons
Time Point Measure Tetracycline ointment + Face washing Tetracycline ointment Comparison Measure Tetracycline ointment + Face washing vs. Tetracycline ointment


12 months

N Analyzed 3 Villages 3 Villages Odds Ratio 0.81
Mean 95% CI low 0.42
SD 95% CI high 1.59
SE
Outcome: Number of participants with severe trachoma      Population: All Participants Between-Arm Comparisons
Time Point Measure Tetracycline ointment + Face washing Tetracycline ointment Comparison Measure Tetracycline ointment + Face washing vs. Tetracycline ointment


12 months

N Analyzed 3 Villages 3 Villages Odds Ratio 0.62
Mean 95% CI low 0.40
SD 95% CI high 0.97
SE
Outcome: Number of participants with a clean face      Population: All Participants Between-Arm Comparisons
Time Point Measure Tetracycline ointment + Face washing Tetracycline ointment Comparison Measure Tetracycline ointment vs. Tetracycline ointment + Face washing


6 months

N Analyzed 3 Villages 3 Villages Odds Ratio
Mean 33% 30% 95% CI low
SD 95% CI high
SE


12 months

N Analyzed 3 Villages 3 Villages Odds Ratio 0.58
Mean 35% 26% 95% CI low 0.47
SD 95% CI high 0.72
SE

Adverse Events
Arm or Total Title Description Comments