Cancer
Conditions
Interventions
HPV E6 E7 Oncoprotein Rapid Test
Sponsors
University of Lagos
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women aged 25 years or older. Presenting with an abnormal cervical cancer screening test result, defined as: Abnormal Pap smear cytology (e.g., ASC-US, LSIL, HSIL), Positive HPV DNA test and abnormal findings on Visual Inspection with Acetic Acid (VIA). Willing and able to provide written informed consent. Willing to undergo both the HPV E6/E7 oncoprotein test and Pap smear, as well as colposcopy with or without biopsy. Able to understand and follow instructions for self-sampling
Exclusion criteria
Exclusion criteria: Confirmed diagnosis of invasive cervical cancer. Current pregnancy Ongoing vaginal bleeding that would interfere with sample collection. History of total hysterectomy (removal of cervix). Known allergy or sensitivity to any component of the test kits or sampling devices. Declines or withdraws consent at any point in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy (sensitivity and specificity) of the HPV E6/E7 oncoprotein rapid point-of-care test and the Pap smear in detecting histologically confirmed high-grade cervical lesions (CIN2 or worse), using colposcopy with or without biopsy as the reference (gold) standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of the HPV E6/E7 oncoprotein rapid test Measured using a brief post-test questionnaire evaluating participants' comfort, ease of use, and willingness to use the test again or recommend it to others. | — |
Countries
Nigeria
Contacts
Public ContactAyokunle Olumodeji
Lagos State University Teaching Hopsital
Outcome results
None listed