Impact of an educational intervention on women's knowledge and confidence in human papillomavirus self-sampling

ISRCTN ISRCTN78123709
DOI https://doi.org/10.1186/ISRCTN78123709
Protocol serial number N/A
Sponsor International Solidarity Geneva (Solidarité Internationale Genève) (Switzerland)
Funders International Solidarity (Solidarité Internationale), Geneva (Switzerland), The University Hospitals of Geneva (Switzerland), UBS, Geneva (Switzerland)
Submission date
17/12/2013
Registration date
10/01/2014
Last edited
28/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Human papillomavirus (HPV) self-sampling (Self-HPV) has the potential to be used as a primary cervical cancer screening method in low resource settings. Before introducing a new method of screening, especially a self-screening method, women should be aware of the importance of screening and women must accept to collect the samples themselves. However, reports reveal that in Sub-Saharan Africa, women's knowledge about HPV and cervical cancer is low. In addition, although women gladly welcome self-HPV testing, they do not feel comfortable in handling the device and are more confident in the results obtained by a gynaecologist. The aim of this study was to evaluate whether an educational intervention would improve women’s knowledge and confidence in the Self-HPV method.

Who can participate?
Women aged between 25 and 65 years old eligible for cervical cancer screening were enrolled in four health care centers in Yaoundé and the surrounding countryside.

What does the study involve?
Participants were randomly allocated to receive either standard information (control group) or standard information followed by an educational intervention (interventional group). Standard information included explanations about what the test detects (HPV), the link between HPV and cervical cancer and how to perform HPV self-sampling. The educational intervention consisted of a culturally tailored video about HPV, cervical cancer, Self-HPV and its relevancy as a screening test.

What are the possible benefits and risks of participating?
Benefits were an early free screening and the cost of treatment is paid by the sponsor's study.
There were no risk of participating in this study.

Where is the study run from?
This study run form the Faculty of Medicine, University of Geneva, Geneva, Switzerland, the
Department of Gynecology and Obstetrics, University Center Hospital, Yaoundé, Cameroon,
the Department of Gynecology and Obstetrics, Gynecologic Division, Geneva University Hospitals, Geneva,
Switzerland and the Geneva Foundation for Medical Education and Research, Geneva, Switzerland.

When is the study starting and how long is it expected to run for?
This study started in July 2012 and ran for a month.

Who is funding the study?
This study was supported by a grant from International Solidarity Geneva, the University Hospitals of Geneva and UBS Geneva (Switzerland).

Who is the main contact?
Mr Michel Zbinden
Mr Gaëtan Sossauer

Contact information

Mr Michel Zbinden
Scientific

Rue de la Fontenette 9
Geneva
1227
Switzerland

Study information

Primary study designInterventional
Study designRandomized controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleImpact of an educational intervention on women's knowledge and confidence in human papillomavirus self-sampling: a randomized controlled trial in Cameroon
Study objectivesHuman papillomavirus (HPV) self-sampling (Self-HPV) has the potential to be used as a primary cervical cancer screening method in a low resource setting. Our aim was to evaluate whether an educational intervention would improve women’s knowledge and confidence in the Self-HPV method.
Ethics approval(s)National Research Committee of Cameroon, ref: 159/CNE/SE/2012
Health condition(s) or problem(s) studiedEducational video improves cervix cancer knowledge
InterventionParticipants 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.
Intervention typeOther
Primary outcome measure(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.

Key secondary outcome measure(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”.

Completion date12/08/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration302
Key inclusion criteria1. Women aged between 25 and 65 years old eligible for cervical cancer screening
2. Willing to give written informed consent
Key exclusion criteria1. Pregnancies
2. Previous hysterectomies or cervical surgery
Date of first enrolment15/07/2012
Date of final enrolment12/08/2012

Locations

Countries of recruitment

  • Cameroon
  • Switzerland

Study participating centre

Rue de la Fontenette 9
Geneva
1227
Switzerland

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/10/2014 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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