Primary HPV Self-Collection in Indonesia

Dharmais National Cancer Center Hospital

Status: Not yet enrolling

Conditions: CIN - Cervical Intraepithelial Neoplasia; Cervical Cancers; Human Papillomavirus (HPV)

Treatments: Diagnostic Test: HPV Self-Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT06942286

DP.04.03/11.10/041/2025

Details and patient eligibility

About

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

Full 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.

Enrollment: 8,000 estimated patients

Sex: Female

Ages: 30 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 30-69 years old
• Have not had a Pap test within the last 3 years or an HPV test within the last 5 years
• Have never been diagnosed with cervical cancer or high-grade dysplasia
• Have no history of hysterectomy with cervical removal
• Expressed willingness to participate in the study, including conducting HPV self-collection, follow-up treatment, and related surveys
• Speak Indonesian or English

Exclusion criteria

• Being pregnant or within 6 weeks postpartum
• Women who have never engaged in sexual activity
• Medical, psychiatric, or other conditions that may interfere with compliance with protocols, security assessments, and/or ability/competence to give informed consent
• Adults who do not have the capacity to give consent may be excluded, as participants must be able to perform activities required by the protocol

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8,000 participants in 1 patient group

HPV Self-Collection

Experimental group

Description:

Participants will perform HPV self-collection.

Treatment:

Diagnostic Test: HPV Self-Collection