Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon (PCCCP)

Prof. Patrick Petignat

Status: Active, not recruiting

Conditions: Cervical Cancer

Treatments: Diagnostic Test: HPV Test

Study type: Interventional

Funder types: Other

Identifiers

NCT03757299

2017-01110

Details and patient eligibility

About

In sub-Saharan Africa, cervical cancer is the leading cause of cancer death among women because of the difficulty in implementing screening programs. The main obstacles in these countries are poverty, lack of healthcare infrastructures and trained practitioners. With the availability of new technologies, researchers are looking for new strategies adapted to low- and middle-income countries to identify cervical precancerous lesions.

Current evidence shows that Human Papilloma Virus (HPV) testing is more effective than cytology (Pap smear) for cervical cancer screening in resource-limited settings. Indeed, the GeneXpert® HPV test offers the opportunity to prevent cervical cancer (CC) in a single visit: rapid detection of high-risk HPV (HPV) infection followed by same day treatment of HPV-positive women during the same visit (screen-and-treat approach).

However only a small proportion of HPV-positive women will develop cervical (pre)cancer, making it important to select those to treat. This triage can be achieved by colposcopy, cytology and visual inspection after application of acetic acid (VIA). Though VIA is the triage test recommended by WHO for resource-limited countries, it has not yet been widely assessed in sub-Saharan Africa (SSA).

The main objective of the investigators is to assess the performance of HPV-test followed by Visual Inspection after application of Acetic acid and Lugol's iodine VIA/VILI to detect cervical precancerous lesions in a screen-and-treat strategy in Cameroon (sub-Saharan Africa) where there is no cervical cancer-screening program.

The investigators organized a successful free screening campaign in Cameroon in 2015 that allowed to identify the expectations of women and their eagerness to benefit from prevention of gynecological cancers and sexually transmitted diseases.

Enrollment: 4,473 patients

Sex: Female

Ages: 30 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 30-49 years, able to comply with the study protocol

Exclusion criteria

• Pregnancy
• Previous total hysterectomy
• Conditions impairing examination of the cervix

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,473 participants in 1 patient group

Self HPV

Experimental group

Treatment:

Diagnostic Test: HPV Test