Primary HPV Self-Collection in Indonesia

NCT06942286 | Enrolling By Invitation

• 1 other identifier: DP.04.03/11.10/041/2025
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Keywords

Human Papilomavirus (HPV); Cervical Cancer; Cervical Dysplasia; HPV Self-Collection; HPV Self-Sampling; Primary HPV Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• HPV Self-Collection Invitation Coverage

  from enrollment to receipt of results, up to 8 weeks

• HPV Self-Collection Participation Rate

  from enrollment to receipt of results, up to 8 weeks

• Examination Coverage of HPV Self-Collection

  from enrollment to receipt of results, up to 8 weeks

• HPV Self-Collection Acceptance Rate

  from enrollment to specimen collection, up to 2 weeks

• Preference for HPV Self-Collection

  from enrollment to specimen collection, up to 2 weeks

Other Outcomes (5)

• HPV Test Validity

  from specimen collection to receipt of results, up to 6 weeks

• Time from HPV Self-Collection to Receipt of Sample in Lab

  from specimen collection to receipt of sample in laboratory, up to 2 weeks

• Time from Receipt of Sample in Lab to Result Reporting

  receipt of sample in laboratory to receipt of results, up to 4 weeks

Study Arms (1)

HPV Self-Collection

EXPERIMENTAL

Participants will perform HPV self-collection.

Diagnostic Test: HPV Self-Collection

Interventions

HPV Self-Collection DIAGNOSTIC_TEST

Participants will perform HPV self-collection.

HPV Self-Collection

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dharmais National Cancer Center Hospital: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (3)

Puskesmas Lebak

Lebak, Banten, Indonesia

Location

Dharmais National Cancer Center Hospital

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

Location

Puskesmas Depok

Depok, West Java, Indonesia

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Study Officials

• Widyorini L Hanafi, MD

  Dharmais National Cancer Center Hospital

  PRINCIPAL INVESTIGATOR

• Dian T Sinulingga, MD, M.Epid

  Dharmais National Cancer Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 24, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)