Condition category
Cancer
Date applied
17/12/2013
Date assigned
10/01/2014
Last edited
28/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michel Zbinden

ORCID ID

Contact details

Rue de la Fontenette 9
Geneva
1227
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact of an educational intervention on women's knowledge and confidence in human papillomavirus self-sampling: a randomized controlled trial in Cameroon

Acronym

Study hypothesis

Human 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

National Research Committee of Cameroon, ref: 159/CNE/SE/2012

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Educational video improves cervix cancer knowledge

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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”.

Overall trial start date

15/07/2012

Overall trial end date

12/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged between 25 and 65 years old eligible for cervical cancer screening
2. Willing to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

302

Participant exclusion criteria

1. Pregnancies
2. Previous hysterectomies or cervical surgery

Recruitment start date

15/07/2012

Recruitment end date

12/08/2012

Locations

Countries of recruitment

Cameroon

Trial participating centre

Rue de la Fontenette 9
Geneva
1227
Switzerland

Sponsor information

Organisation

International Solidarity Geneva (Solidarité Internationale Genève) (Switzerland)

Sponsor details

Bureau de la solidarité internationale
15
rue Pierre-Fatio
Geneva
1204
Switzerland

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

International Solidarity (Solidarité Internationale), Geneva (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The University Hospitals of Geneva (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UBS, Geneva (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25333793

Publication citations

  1. Results

    Sossauer G, Zbinden M, Tebeu PM, Fosso GK, Untiet S, Vassilakos P, Petignat P, Impact of an Educational Intervention on Women's Knowledge and Acceptability of Human Papillomavirus Self-Sampling: A Randomized Controlled Trial in Cameroon., PLoS ONE, 2014, 9, 10, e109788, doi: 10.1371/journal.pone.0109788.

Additional files

Editorial Notes