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

• Register: ISRCTN
• Last refreshed on: 9 January 2023
• Main ID: ISRCTN99459678
• Date of registration: 01/11/2015
• Prospective Registration: No
• Primary sponsor: Geneva University Hospitals (Hôpitaux Universitaires de Genève)
• Public title: Feasibility of a single-visit approach using rapid HPV-testing in Cameroon
• Scientific title: Cervical cancer screening in Cameroon: feasibility of a single-visit approach using rapid HPV-testing
• Date of first enrolment: 08/07/2015
• Target sample size: 1000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN99459678
• Study type: Interventional
• Study design: Prospective non-randomised study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Cameroon

Contacts

• Name: Patrick Petignat

Key inclusion & exclusion criteria

Inclusion criteria:
1. Women aged 30-49
2. Understanding of study procedures

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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical cancer
Cancer
Cervical cancer

Intervention(s)

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.

Primary Outcome(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

Secondary Outcome(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

Secondary ID(s)

15-068

Source(s) of Monetary Support

Geneva University Hospitals, National Fight Against Cancer Committee

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/08/2016