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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Human Papillomavirus (HPV); CIN - Cervical Intraepithelial Neoplasia; Cervical Cancers
• Intervention / Treatment: Diagnostic test: HPV Self-Collection

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.

• Study Type: Interventional
• Enrollment (Estimated): 8000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Banten
    • Lebak, Banten, Indonesia
      • Puskesmas Lebak
  • Jakarta Special Capital Region
    • Jakarta, Jakarta Special Capital Region, Indonesia, 11420
      • Dharmais National Cancer Center Hospital
  • West Java
    • Depok, West Java, Indonesia
      • Puskesmas Depok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV Self-Collection; Participants will perform HPV self-collection.	Diagnostic test: HPV Self-Collection; Participants will perform HPV self-collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of HPV Self-Collection	number of subjects with valid HPV test results from self-collection / number of eligible subjects	from enrollment to receipt of results, up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Self-Collection Participation Rate	number of subjects with samples received at the laboratory / number of invited subjects	from enrollment to receipt of results, up to 8 weeks
HPV Self-Collection Invitation Coverage	number of subjects with valid HPV test results from self-collection / total eligible population in the catchment area	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	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	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	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	from receipt of results to follow-up exam, up to 60 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Test Validity	number of valid HPV test results / number of HPV tests	from specimen collection to receipt of results, up to 6 weeks
Time from HPV Self-Collection to Receipt of Sample in Lab	number of days from HPV self-collection until sample is received in the laboratory	from specimen collection to receipt of sample in laboratory, up to 2 weeks
Time from Receipt of Sample in Lab to Result Reporting	number of days from receipt of HPV sample in laboratory to availability of results	receipt of sample in laboratory to receipt of results, up to 4 weeks
Time from Result Reporting to Patient Follow-up	number of days from result reporting to patient presenting for follow-up examination	from receipt of results to follow-up exam, up to 6 months
Average Cycle Threshold Values by Genotype	average cycle threshold value for each genotype in all subjects with a reportable cycle threshold value for that genotype	from specimen collection to receipt of results, up to 6 weeks

Collaborators and Investigators

• Sponsor: Dharmais National Cancer Center Hospital
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Widyorini L Hanafi, MD, Dharmais National Cancer Center Hospital; Principal Investigator: Dian T Sinulingga, MD, M.Epid, Dharmais National Cancer Center Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Cervical Cancer; Cervical Dysplasia; Human Papilomavirus (HPV); HPV Self-Collection; HPV Self-Sampling; Primary HPV Test
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Precancerous Conditions; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
• Other Study ID Numbers: DP.04.03/11.10/041/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No