Risk-Stratified versus Cytology-Based Triage of Non-HPV 16/18-Positive for Detection of High-Grade Cervical Intraepithelial Neoplasia: A Non-Inferiority Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202606895128487

Enrollment

148

Registered

2026-06-02

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Risk stratified triage

Cytology based triage

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women aged 30–65 years Women with laboratory confirmation of hrHPV infection with one or more non-HPV16/18 types (e.g., 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, or 68) using the validated Xpert® HPV platform Women who are willing to provide written informed consent and comply with study follow-up.

Exclusion criteria

Exclusion criteria: Women with laboratory detection of HPV16 and/or HPV18 infection (triaged per standard-of-care protocols) Women with a previous diagnosis of CIN2+, cervical cancer, or a history of hysterectomy Women with a current pregnancy Women with immunosuppression unrelated to HIV Women with prior HPV vaccination Women with an inability to provide informed consent or complete study procedures.

Design outcomes

Primary

Measure	Time frame
The detection of histologically confirmed CIN2+ lesions in each study arm	—

Secondary

Measure	Time frame
Diagnostic performance metrics (sensitivity, specificity, PPV, NPV) of the risk-stratified algorithm versus cytology for CIN2+ detection	—

Countries

Nigeria

Contacts

Public ContactKehinde Okunade

Professor of Obstetrics and Gynaecology

sokunade@unilag.edu.ng+2348034728139

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026