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Enrolling by Invitation

NCT Number: NCT06942286

Primary HPV Self-Collection in Indonesia

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

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Key information

Conditions

Cervical Cancers CIN - Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus (HPV) Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Puskesmas Lebak, Lebak, Banten, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV Self-Collection

Diagnostic Test

Participants will perform HPV self-collection.

Primary outcomes

  1. Success Rate of HPV Self-Collection

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

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

Secondary outcomes

  1. HPV Self-Collection Invitation Coverage

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

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

  2. HPV Self-Collection Participation Rate

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

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

  3. Examination Coverage of HPV Self-Collection

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

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

  4. HPV Self-Collection Acceptance Rate

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

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

  5. Preference for HPV Self-Collection

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

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

  6. Patient Follow-up Rate

    Time frame: from receipt of results to follow-up exam, up to 60 days

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

Other outcomes

  1. HPV Test Validity

    Time frame: from specimen collection to receipt of results, up to 6 weeks

    number of valid HPV test results / number of HPV tests

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

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

    number of days from HPV self-collection until sample is received in the laboratory

  3. Time from Receipt of Sample in Lab to Result Reporting

    Time frame: receipt of sample in laboratory to receipt of results, up to 4 weeks

    number of days from receipt of HPV sample in laboratory to availability of results

  4. Time from Result Reporting to Patient Follow-up

    Time frame: from receipt of results to follow-up exam, up to 6 months

    number of days from result reporting to patient presenting for follow-up examination

  5. Average Cycle Threshold Values by Genotype

    Time frame: from specimen collection to receipt of results, up to 6 weeks

    average cycle threshold value for each genotype in all subjects with a reportable cycle threshold value for that genotype

Sponsors and collaborators

Lead sponsor

Dharmais National Cancer Center Hospital

Other Gov

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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