Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

NCT03757299 | Completed DMC

• 1 other identifier: 2017-01110
• Study Type: interventional
• Target: 4,473
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard

  VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard

  3 - 5 years

Secondary Outcomes (14)

• Prevalence of HPV infection

  3 - 5 years

• Prevalence of cervical pre-cancer and cancer among Cameroonian women

  3 - 5 years

• HPV clearance

  3 - 5 years

• Persistance of CIN2+ disease at the 12-month follow-up

  3 - 5 years

• Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)

  3 - 5 years

Study Arms (1)

Self HPV

EXPERIMENTAL

Diagnostic Test: HPV Test

Interventions

HPV Test DIAGNOSTIC_TEST

Vaginal 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%.

Also known as: VIA/VILI,, Pap smear,, Cervical biopsy, ECC

Self HPV

Eligibility Criteria

• Age: 30 Years - 49 Years
• Gender Eligibility Details: Only women will be recruited by the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Prof. Patrick Petignat: lead

Study Sites (1)

University of Geneva

Geneva, 1205, Switzerland

Location

Related Publications (4)

• Sormani J, Moukam A, Wisniak A, Yakam V, Schmidt NC, Kenfack B, Petignat P. Psychological and sexual impact of human papillomavirus screening in women in Cameroon: a prospective cohort study. BMC Womens Health. 2025 Dec 19;25(1):602. doi: 10.1186/s12905-025-04083-6.

  PMID: 41420163 DERIVED

• Broquet C, Vassilakos P, Ndam Nsangou FM, Kenfack B, Noubom M, Tincho E, Jeannot E, Wisniak A, Petignat P. Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy. BMJ Open. 2022 Dec 22;12(12):e057234. doi: 10.1136/bmjopen-2021-057234.

  PMID: 36549727 DERIVED

• Petignat P, Kenfack B, Wisniak A, Saiji E, Tille JC, Tsuala Fouogue J, Catarino R, Tincho E, Vassilakos P. ABCD criteria to improve visual inspection with acetic acid (VIA) triage in HPV-positive women: a prospective study of diagnostic accuracy. BMJ Open. 2022 Apr 4;12(4):e052504. doi: 10.1136/bmjopen-2021-052504.

  PMID: 35379615 DERIVED

• Metaxas T, Kenfack B, Sormani J, Tincho E, Lemoupa Makajio S, Wisniak A, Vassilakos P, Petignat P. Acceptability and safety of thermal ablation to prevent cervical cancer in sub-Saharan Africa. BMC Cancer. 2022 Feb 2;22(1):132. doi: 10.1186/s12885-022-09202-2.

  PMID: 35109806 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Human Papillomavirus DNA Tests; Papanicolaou Test

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Molecular Diagnostic Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Biopsy; Cytodiagnosis; Cytological Techniques; Specimen Handling; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the gynecology departement

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 28, 2018
• Study Start: October 1, 2018
• Primary Completion: December 5, 2022
• Study Completion: July 9, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

CH (1)