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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: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN78123709
Date of registration: 10/01/2014
Prospective Registration: No
Primary sponsor: International Solidarity Geneva (Solidarité Internationale Genève) (Switzerland)
Public title: Impact of an educational intervention on women's knowledge and confidence in human papillomavirus self-sampling
Scientific title: 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: 15/07/2012
Target sample size: 302
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN78123709
Study type:  Interventional
Study design:  Randomized controlled trial (Treatment)  
Phase: 
Countries of recruitment
Cameroon
Contacts
Name: Michel    Zbinden
Address:  Rue de la Fontenette 9 1227 Geneva Switzerland
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
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Affiliation: 
Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender: Female
Health Condition(s) or Problem(s) studied
Educational video improves cervix cancer knowledge
Cancer
Intervention(s)
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.
Primary Outcome(s)
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.
Secondary Outcome(s)
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?.
Secondary ID(s)
N/A
Source(s) of Monetary Support
International Solidarity (Solidarité Internationale), Geneva (Switzerland), The University Hospitals of Geneva (Switzerland), UBS, Geneva (Switzerland)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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