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

What this trial studies

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.

Conditions in scope

• Cervical Cancer Screening
• HPV Infections
• Cervical Intraepithelial Neoplasia

Interventions

• Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators. (Diagnostic Test) — 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…

Who can join

Women only · Ages 50 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Women aged 50 to 65 years old;
• Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).

Exclusion criteria

• Women who is pregnant;
• Women with a condition that interfere with visualization of the cervix;
• Women with vaginal bleeding outside the menstrual period;
• Women who have had a total hysterectomy;
• Women with a history of cervical cancer;
• Women screened for cervical cancer in the last 5 years or in the last 3 years if HIV-positive;
• Women in the terminal phase of an illness.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2024-06-01
• Primary completion: 2024-12-31
• Last update posted: 2026-01-21
• First posted: 2025-11-24

Sponsor & contact

Lead sponsor: University Hospital, Geneva (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Sensitivity and specificity of HPV test followed by cytology to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard (1 year)
  To determine the diagnostic performance of screening strategies using HPV testing with cytology triage and/or extended genotyping in women aged between 50 and 65 years for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+);

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