Clinical Trials Directory

Trials / Completed

CompletedNCT03757299

Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
4,473 (actual)
Sponsor
Prof. Patrick Petignat · Academic / Other
Sex
Female
Age
30 Years – 49 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTHPV TestVaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators. Two transport mediums will be used for those self-collected vaginal samples: NaCl 0.9%.

Timeline

Start date
2018-10-01
Primary completion
2022-12-05
Completion
2024-07-09
First posted
2018-11-28
Last updated
2025-01-15

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03757299. Inclusion in this directory is not an endorsement.