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

December 8, 2023 updated by: Prof. Patrick Petignat

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4473

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • University of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self HPV
Diagnostic test: HPV 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%.
Other Names:
  • Cervical biopsy
  • VIA/VILI,
  • Pap smear,
  • ECC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of HPV infection
Time Frame: 3 - 5 years
HPV self-test analysed by GeneXpert machine
3 - 5 years
Prevalence of cervical pre-cancer and cancer among Cameroonian women
Time Frame: 3 - 5 years
Histological analyses of cervical biopsies and endocervical brushing
3 - 5 years
HPV clearance
Time Frame: 3 - 5 years
Measured by self HPV performed at 6 and 12 months follow up
3 - 5 years
Persistance of CIN2+ disease at the 12-month follow-up
Time Frame: 3 - 5 years
Histological analyses of cervical biopsies and endocervical brushing
3 - 5 years
Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)
Time Frame: 3 - 5 years
images database
3 - 5 years
Acceptability rate of self-HPV test and cervical cancer screening procedures
Time Frame: 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).
3 years
Proportion of side effects and complications after thermoablation or LEEP
Time Frame: 3 - 5 years
questionnaire
3 - 5 years
VIA test-positive rate (HPV-positive women);
Time Frame: 3 - 5 years
VIA/VILI is assessed by pelvic examination
3 - 5 years
VIA test-positive rate after 1- year follow-up of VIA-negative tests
Time Frame: 3 - 5 years
VIA/VILI is assessed by pelvic examination
3 - 5 years
Thermal ablation efficacy rate
Time Frame: 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
3 - 5 years
Acceptability rate of thermoablation
Time Frame: 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)
3 years
Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,
Time Frame: 2 years
SF12, Asex, STAI 6 Y-form
2 years
Number of women screened with and without community health care workers.
Time Frame: 2 years
community health workers registre
2 years
Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,
Time Frame: 3-5 years
questionnaire
3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Patrick Petignat

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 5, 2022

Study Completion (Estimated)

December 5, 2024

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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