Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Diagnostic Test: HPV Test

• Registration Number: NCT03757299
• Lead Sponsor: Prof. Patrick Petignat

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Primary Completion: 2022-12-05
• Study Completion: 2024-07-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4473

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self HPV	HPV Test	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard	3 - 5 years	VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard

Secondary Outcome Measures

Name	Time	Method
Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)	3 - 5 years	images database
Acceptability rate of self-HPV test and cervical cancer screening procedures	3 years	To assess the acceptability of self-HPV, patients complete a questionnaire comprising different questions about the collection device (embarassment, comfort, anxiety and confidence about the test).; Likert Scale 4 points : 1 (not at all) to 4 (very).
Thermal ablation efficacy rate	3 - 5 years	Thermal ablation efficacy rate will be assessed according to the biopsy proven CIN2+ rate after thermoablation treatment at the 6 and 12-month follow-up. The absence of CIN2+ will determine the success of the treatment in a patient who previously had a CIN2+ lesion.; Adverses event : bleeding, complications, hospitalization
Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,	2 years	SF12, Asex, STAI 6 Y-form
VIA test-positive rate after 1- year follow-up of VIA-negative tests	3 - 5 years	VIA/VILI is assessed by pelvic examination
Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,	3-5 years	questionnaire
Prevalence of HPV infection	3 - 5 years	HPV self-test analysed by GeneXpert machine
Prevalence of cervical pre-cancer and cancer among Cameroonian women	3 - 5 years	Histological analyses of cervical biopsies and endocervical brushing
Proportion of side effects and complications after thermoablation or LEEP	3 - 5 years	questionnaire
Acceptability rate of thermoablation	3 years	To assess the acceptability of thermoablation, patients completed a questionnaire comprising different questions about treatment tolerance, pain and following side effects. Respondent were invited to rate answers on a likert scale of 1 (no accpetability) to 4 (high acceptability)
Number of women screened with and without community health care workers.	2 years	community health workers registre
VIA test-positive rate (HPV-positive women);	3 - 5 years	VIA/VILI is assessed by pelvic examination
HPV clearance	3 - 5 years	Measured by self HPV performed at 6 and 12 months follow up
Persistance of CIN2+ disease at the 12-month follow-up	3 - 5 years	Histological analyses of cervical biopsies and endocervical brushing

Trial Locations

Locations (1)

University of Geneva; 🇨🇭 Geneva, Switzerland