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Cervical Cancer Screening of Postmenopausal Women in Low- and Middle-income Countries Using HPV Self-sampling and Triage by Genotyping and Cytology

NCT07244315 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-01-21

No results posted yet for this study

Summary

Cervical cancer remains a major cause of mortality in low- and middle-income countries, especially among women aged 50 years and older who are often under-screened. In post-menopausal women, the transformation zone is frequently not visible, which makes visual inspection with acetic acid (VIA) less reliable and limits access to adequate screening. Human papillomavirus (HPV) self-sampling offers a simple and acceptable primary screening method, but effective triage options for HPV-positive women in this age group remain limited.

This study aims to evaluate the feasibility and diagnostic performance of a screening strategy based on HPV self-sampling followed by Pap cytology triage among HPV-positive women aged 50 to 65 years in Cameroon. Approximately 500 women will be invited to perform self-HPV testing at the Mifi District Hospital. HPV-positive women will undergo Pap cytology, endocervical brushing and digital cervicography, and eligible participants will receive treatment with thermal ablation at Bafoussam Regional Hospital. Follow-up at 12 months will include repeat HPV testing, cytology, and endocervical brushing.

The primary outcome is the diagnostic accuracy of HPV + cytology triage for detecting CIN2+. Secondary outcomes include prevalence of high-risk HPV, treatment outcomes, acceptability, and adherence to follow-up.

Conditions

  • Cervical Cancer Screening
  • HPV Infections
  • Cervical Intraepithelial Neoplasia

Interventions

DIAGNOSTIC_TEST

Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators.

Women will perform a self-collected vaginal sample for the detection of high-risk human papillomavirus (HPV) DNA using a molecular assay (HPV DNA test). The sample will be collected using a sterile flocked swab and placed in a transport medium. Laboratory analysis will be conducted at the Mifi District Hospital using the GeneXpert HPV assay (Cepheid, USA). Women who test positive for high-risk HPV will undergo cytology triage (Pap test) and, if cytology is positive (≥ASC-US), will be offered thermal ablation at Bafoussam Regional Hospital.

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Cameroon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07244315 on ClinicalTrials.gov