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Enrolling by invitation NCT06942286

Primary HPV Self-Collection in Indonesia

No phase Interventional Cervical Cancers CIN - Cervical Intraepithelial Neoplasia Human Papillomavirus (HPV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HPV Self-Collection.
Who it may be relevant to
Registry conditions: Cervical Cancers, CIN - Cervical Intraepithelial Neoplasia, Human Papillomavirus (HPV). Basic parameters: 30 years — 69 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test HPV Self-Collection
    Participants will perform HPV self-collection.

Primary outcome measures

  • Success Rate of HPV Self-Collection [Time frame: from enrollment to receipt of results, up to 8 weeks]
Secondary outcome measures (6)
  • HPV Self-Collection Invitation Coverage [Time frame: from enrollment to receipt of results, up to 8 weeks]
  • HPV Self-Collection Participation Rate [Time frame: from enrollment to receipt of results, up to 8 weeks]
  • Examination Coverage of HPV Self-Collection [Time frame: from enrollment to receipt of results, up to 8 weeks]
  • HPV Self-Collection Acceptance Rate [Time frame: from enrollment to specimen collection, up to 2 weeks]
  • Preference for HPV Self-Collection [Time frame: from enrollment to specimen collection, up to 2 weeks]
  • Patient Follow-up Rate [Time frame: from receipt of results to follow-up exam, up to 60 days]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Indonesia · 3 centers
  • Puskesmas Lebak — Lebak
  • Dharmais National Cancer Center Hospital — Jakarta
  • Puskesmas Depok — Depok

Identifiers

NCT: NCT06942286 · DP.04.03/11.10/041/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗