Primary HPV Self-Collection in Indonesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-13

Study Completion Date

2027-04-30

Brief Summary

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

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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HPV Self-Collection

Participants will perform HPV self-collection.

Group Type EXPERIMENTAL

HPV Self-Collection

Intervention Type DIAGNOSTIC_TEST

Participants will perform HPV self-collection.

Interventions

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HPV Self-Collection

Participants will perform HPV self-collection.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes