NCT06942286

Primary HPV Self-Collection in Indonesia

HPV DNA Screening With Self-Collection Method and Its Management in the Context of Population-Based Cervical Cancer Screening Pilot Project in Indonesia

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,000 (estimated)
• Sponsor: Dharmais National Cancer Center Hospital · Other Government
• Sex: Female
• Age: 30 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to implement human papillomavirus (HPV) self-collection in Indonesia.

Detailed description

After participants give informed consent, they will receive a short educational session about cervical cancer and HPV, after which they will be offered the opportunity to undergo primary HR-HPV testing via self-collection. Participants will be contacted within 4 weeks with their results. Those who test positive for high-risk HPV will receive a follow-up appointment, at which time visual assessment with acetic acid and/or colposcopy will be performed. Those with detectable lesions and/or HPV 16/18+ will undergo treatment with thermal ablation. If they are ineligible for thermal ablation, they will undergo cervical biopsy, endocervical curettage, and/or loop electrosurgical excision procedure (LEEP) as indicated. Anyone with suspicion for cancer will undergo biopsies and referral to a gynecologic oncologist.

Conditions

• Cervical Cancers
• CIN - Cervical Intraepithelial Neoplasia
• Human Papillomavirus (HPV)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HPV Self-Collection	Participants will perform HPV self-collection.

Timeline

• Start date: 2025-08-13
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-04-24
• Last updated: 2025-09-17

Locations

3 sites across 1 country: Indonesia