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Completed

NCT Number: NCT03757299

Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

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.

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Key information

Conditions

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

Age range

30 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Geneva

Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%.

Other names: VIA/VILI,, Pap smear,, Cervical biopsy, ECC

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

    Time frame: 3 - 5 years

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

Secondary outcomes

  1. Prevalence of HPV infection

    Time frame: 3 - 5 years

    HPV self-test analysed by GeneXpert machine

  2. Prevalence of cervical pre-cancer and cancer among Cameroonian women

    Time frame: 3 - 5 years

    Histological analyses of cervical biopsies and endocervical brushing

  3. HPV clearance

    Time frame: 3 - 5 years

    Measured by self HPV performed at 6 and 12 months follow up

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

    Time frame: 3 - 5 years

    Histological analyses of cervical biopsies and endocervical brushing

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

    Time frame: 3 - 5 years

    images database

  6. 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).

  7. Proportion of side effects and complications after thermoablation or LEEP

    Time frame: 3 - 5 years

    questionnaire

  8. VIA test-positive rate (HPV-positive women);

    Time frame: 3 - 5 years

    VIA/VILI is assessed by pelvic examination

  9. 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

  10. 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

  11. 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)

  12. Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,

    Time frame: 2 years

    SF12, Asex, STAI 6 Y-form

  13. Number of women screened with and without community health care workers.

    Time frame: 2 years

    community health workers registre

  14. 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

Sponsors and collaborators

Lead sponsor

Prof. Patrick Petignat

Other

Registry information

Acronym: PCCCP

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Nov 28, 2018
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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