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

NCT07244315 | Completed

• 2 other identifiers: N°/537/29/05/2024/CE/CRERSH-OUAO_2024-00066
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

HPV Infections; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia

Keywords

cytology; post-menopausal women; cervical cancer screening

Outcome Measures

Primary Outcomes (1)

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

  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+);

  1 year

Study Arms (1)

Women from the general population aged 50-65 years old

Women from the general population aged 50-65 years old eligible for screening in the West region of Cameroon. 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.

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

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 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.

Also known as: VIA/VILI, Pap smear, Cervical biopsy, Endo-cervical brushing, HPV test

Women from the general population aged 50-65 years old

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The source population is the entire population of women aged between 50 and 65 years old in the Mifi health district.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Bafoussam Regional Hospital

Bafoussam, Cameroon

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Dysplasia

Interventions

Papanicolaou Test; Human Papillomavirus DNA Tests

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Gynecologic Division

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-11

Locations

CA (1)