Clinical trial NCT06942286: Primary HPV Self-Collection in Indonesia
Official title: HPV DNA Screening With Self-Sampling Method and Its Management in the Context of Population-Based Cervical Cancer Screening Pilot Project in Indonesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Dharmais National Cancer Center Hospital
Sponsor class: OTHER_GOV
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2025-04-24
Enrollment: 8000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

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.

Eligibility criteria: 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
* Speak Indonesian or English

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

Primary outcomes:
measure: Success Rate of HPV Self-Collection
timeFrame: from enrollment to receipt of results, up to 8 weeks
Secondary outcomes:
measure: HPV Self-Collection Participation Rate
timeFrame: from enrollment to receipt of results, up to 8 weeks
measure: HPV Self-Collection Invitation Coverage
timeFrame: from enrollment to receipt of results, up to 8 weeks
measure: Examination Coverage of HPV Self-Collection
timeFrame: from enrollment to receipt of results, up to 8 weeks
measure: HPV Self-Collection Acceptance Rate
timeFrame: from enrollment to specimen collection, up to 2 weeks
measure: Preference for HPV Self-Collection
timeFrame: from enrollment to specimen collection, up to 2 weeks
measure: Patient Follow-up Rate
timeFrame: from receipt of results to follow-up exam, up to 6 months
Other outcomes:
measure: HPV Test Validity
timeFrame: from specimen collection to receipt of results, up to 6 weeks
measure: Time from HPV Self-Collection to Receipt of Sample in Lab
timeFrame: from specimen collection to receipt of sample in laboratory, up to 2 weeks
measure: Time from Receipt of Sample in Lab to Result Reporting
timeFrame: receipt of sample in laboratory to receipt of results, up to 4 weeks
measure: Time from Result Reporting to Patient Follow-up
timeFrame: from receipt of results to follow-up exam, up to 6 months
measure: Average Cycle Threshold Values by Genotype
timeFrame: from specimen collection to receipt of results, up to 6 weeks
Locations:
city: West Jakarta
country: Indonesia
facility: Dharmais National Cancer Center Hospital
state: Jakarta
Study officials:
affiliation: Dharmais National Cancer Center Hospital
name: Widyorini L Hanafi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dharmais National Cancer Center Hospital
name: Dian T Sinulingga, MD, M.Epid
role: PRINCIPAL_INVESTIGATOR
References: