Primary HPV Self-Collection in Indonesia

N/AEnrolling By InvitationNCT06942286

Dharmais National Cancer Center Hospital8,000 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

8,000

Conditions

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

Interventions

HPV Self-CollectionDIAGNOSTIC_TEST

Participants will perform HPV self-collection.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Puskesmas Lebak

Lebak, Banten, Indonesia

Dharmais National Cancer Center Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Puskesmas Depok

Depok, West Java, Indonesia

Outcomes

Primary Outcomes

Success Rate of HPV Self-Collection

number of subjects with valid HPV test results from self-collection / number of eligible subjects

Time frame: from enrollment to receipt of results, up to 8 weeks

Secondary Outcomes

HPV Self-Collection Invitation Coverage

number of subjects with valid HPV test results from self-collection / total eligible population in the catchment area

Time frame: from enrollment to receipt of results, up to 8 weeks

HPV Self-Collection Participation Rate

number of subjects with samples received at the laboratory / number of invited subjects

Time frame: from enrollment to receipt of results, up to 8 weeks

Examination Coverage of HPV Self-Collection

number of subjects with samples received at the laboratory / total eligible population in the catchment area

Time frame: from enrollment to receipt of results, up to 8 weeks

HPV Self-Collection Acceptance Rate

number of subjects who perform self-collection / number of subjects given HPV self-collection kits and instructions

Time frame: from enrollment to specimen collection, up to 2 weeks

Preference for HPV Self-Collection

number of subjects who choose self-collection / number of subjects who answered survey questions

Time frame: from enrollment to specimen collection, up to 2 weeks

Patient Follow-up Rate

number of subjects who receive VIA follow-up within 60 days / number of subjects with positive HPV tests

Data from ClinicalTrials.gov

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