Feasibility of a single-visit approach using rapid HPV-testing in Cameroon

ISRCTN	ISRCTN99459678
DOI	https://doi.org/10.1186/ISRCTN99459678
Protocol serial number	15-068
Sponsor	Geneva University Hospitals (Hôpitaux Universitaires de Genève)
Funders	Geneva University Hospitals, National Fight Against Cancer Committee

Submission date: 13/09/2015
Registration date: 01/11/2015
Last edited: 30/12/2022

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 papilloma viruses (HPV) are a family of viruses which affect the skin and moist membranes (mucosa) lining the body. HPVs are very common viruses, and will affect most people at some point in their lives. These viruses easily spread from person to person via skin-to-skin contact or contact during sex. There are over 100 different types of HPV, with more than 40 affecting the genital area. Some types of HPV, known as high risk types, have been linked to the development of abnormal cells in the cervix. If left untreated, this can greatly increase a woman’s risk of developing cervical cancer. Studies have shown that a large proportion of new cervical cancer cases are found in less developed countries. A possible reason for this is that women in these countries do not have access to vaccinations or a structured screening programme testing for the abnormal cells (Pap smear), due to high costs and a lack of trained healthcare professionals. Rapid HPV self-testing is where the woman herself is able to take a sample which can be tested. This has the advantage of being very inexpensive, and can reach a lot more women, especially in rural areas. The aim of this study is to test how practical and safe self-testing for HPV can be at preventing cervical cancer.

Who can participate?
Healthy women between 30 and 49 years old, with a good understanding of the HPV screening procedure

What does the study involve?
Women are given swabs so that they can take samples to be tested for HPV. Women who have a negative HPV test (absence of a HPV type that is linked to cervical cancer) are provided with reassurance and asked to repeat the test in 5 to 10 years. Women who have a positive HPV test (presence of a HPV type that is linked to cervical cancer) are invited for a visual inspection, where digital photographs of the cervix are taken and reviewed by experts. If the result is abnormal, then the women are offered therapy.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Dschang District Hospital (Cameroon)

When is the study starting and how long is it expected to run for?
June 2014 to August 2016

Who is funding the study?
1. Geneva University Hospitals (Switzerland)
2. National Fight Against Cancer Committee (France)

Who is the main contact?
Prof. Patrick Petignat

Contact information

Prof Patrick Petignat
Public

Boulevard de la Cluse 30
Geneva
1205
Switzerland

ORCID ID	0000-0002-6835-533X

Study information

Primary study design	Interventional
Study design	Prospective non-randomised study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Cervical cancer screening in Cameroon: feasibility of a single-visit approach using rapid HPV-testing
Study objectives	Feasibility of a single-visit approach using rapid HPV-testing in low resource setting as Cameroon.
Ethics approval(s)	1. Commission Cantonale d'Ethique de la Recherche (CCER) de Genève, 16/06/2015, ref: 15-068 2. National Ethics Committee for Human Health Research (Cameroon), 27/02/2015, ref: 2015/02/559/CE/CNERSH/SP
Health condition(s) or problem(s) studied	Cervical cancer
Intervention	All women will take an HPV test. HPV-negative women will be reassured and counseled to repeat the test in 5 to 10 years. HPV-positive women with normal VIA/VILI test will undergo an endocervical curettage (ECC) and cytology to exclude presence of occult disease. HPV-positive women with abnormal VIA/VILI test will undergo a biopsy of abnormal area followed by therapy with cold coagulation. Pictures of the cervix and abnormal areas will be taken to assure a control of quality.
Intervention type	Other
Primary outcome measure(s)	Current primary outcome measures as of 26/09/2017: The feasibility of HPV cervical cancer screen-and-treat approach in a low-resource context, assessed by measuring the number of women who took part in the screening campaign and the relative number of drop-outs and invalid test results at baseline Previous primary outcome measures: The prevalence of HPV infection and cervical pre-cancer and cancer will be determined among Cameroonian women at baseline, 6 months and 1 year
Key secondary outcome measure(s)	Current secondary outcome measures as of 26/09/2017: 1. The prevalence of HPV infection, cervical pre-cancer and cancer among Cameroonian women, determined using rapid HPV testing, cytology and histology at baseline 2. Performance of VIA/VILI and HPV16/18/45 genotyping for detection of high grade cervical lesions, determined using the kappa statistic at baseline 3. The association of risk factors leading to high-risk HPV infection and cervical pre-cancer and cancer, determined using calculated odds ratio (OR) at baseline Previous secondary outcome measures: 1. To compare the agreement between histology and VIA results as well as cervical picture and VIA results, measured using the kappa statistic at 6 and 12 months 2. To evaluate the association of risk factors leading to high-risk HPV infection and promoting cervical neoplasia using calculated odds ratio (OR) at 6 months follow up 3. Verification as to whether HPV self-testing alone is an accurate test and can reduce the need for physician-cervical sampling, measured at 6 months follow up 4. HPV clearance is measured at 6 and 12 months
Completion date	31/08/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Female
Target sample size at registration	1000
Key inclusion criteria	1. Women aged 30-49 2. Understanding of study procedures
Key exclusion criteria	1. Pregnancy 2. Previous hysterectomy 3. Conditions that can interfere with visualization of the cervix (menstruation) 4. Women who not able to comply with protocol study
Date of first enrolment	08/07/2015
Date of final enrolment	04/09/2015

Locations

Countries of recruitment

Cameroon

Study participating centre

Dschang District Hospital

Dschang
-
Cameroon

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The dataset is securely stored in the online database SecuTrial. As only the selected study investigators have access to it, the database will not be available to the public.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2017		Yes	No
Basic results		19/09/2017	19/10/2017	No	No
Other publications		07/01/2017	30/12/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN99459678_BasicResults_19Sep17.pdf: Uploaded 19/10/2017

Editorial Notes

30/12/2022: Publication reference added.
19/10/2017: The basic results of this trial have been uploaded as an additional file.
26/09/2017: IPD sharing statement added.
18/09/2017: Publication reference added.