Feasibility of a single-visit approach using rapid HPV-testing in Cameroon
| ISRCTN | ISRCTN99459678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99459678 |
| Secondary identifying numbers | 15-068 |
- 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
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
Public
Boulevard de la Cluse 30
Geneva
1205
Switzerland
 ORCID ID |
0000-0002-6835-533X |
|---|
Study information
| Study design | Prospective non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 12/06/2014 |
| Completion date | 31/08/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
-
Cameroon
Sponsor information
Hospital/treatment centre
Boulevard de la Cluse 30
Genève
1205
Switzerland
"ROR" |
https://ror.org/01m1pv723 |
|---|
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Geneva University Hospitals, HUG
- Location
- Switzerland
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| 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 |
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.
