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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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13 January 2015 |
Main ID: |
ISRCTN78123709 |
Date of registration:
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10/01/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Impact of an educational intervention on women's knowledge and confidence in human papillomavirus self-sampling
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Scientific title:
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Impact of an educational intervention on women's knowledge and confidence in human papillomavirus self-sampling: a randomized controlled trial in Cameroon |
Date of first enrolment:
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15/07/2012 |
Target sample size:
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302 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN78123709 |
Study type:
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Interventional |
Study design:
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Randomized controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Cameroon
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Contacts
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Name:
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Michel
Zbinden |
Address:
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Rue de la Fontenette 9
1227
Geneva
Switzerland |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Women aged between 25 and 65 years old eligible for cervical cancer screening 2. Willing to give written informed consent
Exclusion criteria: 1. Pregnancies 2. Previous hysterectomies or cervical surgery
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Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Educational video improves cervix cancer knowledge Cancer
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Intervention(s)
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Participants were randomly chosen to receive standard information (control group) or standard information followed by educational intervention (interventional group). 1. Standard information included explanations about what the test detects (HPV), the link between HPV and cervical cancer and how to perform HPV self-sampling. 2. The educational intervention consisted of a culturally tailored video about HPV, cervical cancer, Self-HPV and its relevancy as a screening test.
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Primary Outcome(s)
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Assess the impact of an educational intervention on women?s knowledge about HPV. A 7-item questionnaire was addressed to participants, with 3-point scale answers.
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Secondary Outcome(s)
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Assess the impact of an educational intervention on women?s confidence regarding the Self-HPV test. We conducted a scientific literary review of the questionnaires on cervical cancer knowledge, attitudes and confidence about Self-HPV, in order to base our methodology on previous studies. The acceptability indices were scored on a 4-point scale. For each method, we calculated mean scores for embarrassment, pain, anxiety, discomfort, degree of relaxation (reverse score) and confidence (reverse score). Responses were on a 4-point scale as follows: ?not at all?, ?slightly?, ?moderately? and ?very?. A total ??acceptability score?? for each method was calculated by adding the mean scores of each of these 6 items. A higher score indicates a more negative attitude toward the test. The willingness to perform Self-HPV was tested by the following two questions: ??Do you agree to perform regularly Self-HPV??? and ??Would you recommend the Self-HPV to friends and/or family???. Willingness to test oneself at home was also assessed and possible answers were ?yes?, ?no? and ?do not know?.
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Source(s) of Monetary Support
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International Solidarity (Solidarité Internationale), Geneva (Switzerland), The University Hospitals of Geneva (Switzerland), UBS, Geneva (Switzerland)
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Results
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Results available:
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