Cervical Cancers, CIN - Cervical Intraepithelial Neoplasia, Human Papillomavirus (HPV)
Conditions
Keywords
Human Papilomavirus (HPV), Cervical Cancer, Cervical Dysplasia, HPV Self-Collection, HPV Self-Sampling, Primary HPV Test
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.
Interventions
DIAGNOSTIC_TESTHPV Self-Collection
Participants will perform HPV self-collection.
Sponsors
M.D. Anderson Cancer Center
Dharmais National Cancer Center Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of HPV Self-Collection | 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
| Measure | Time frame | Description |
|---|---|---|
| HPV Self-Collection Participation Rate | from enrollment to receipt of results, up to 8 weeks | number of subjects with samples received at the laboratory / number of invited subjects |
| HPV Self-Collection Invitation Coverage | 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 |
| Examination Coverage of HPV Self-Collection | 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 |
| HPV Self-Collection Acceptance Rate | 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 |
| Preference for HPV Self-Collection | from enrollment to specimen collection, up to 2 weeks | number of subjects who choose self-collection / number of subjects who answered survey questions |
| Patient Follow-up Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Time from Receipt of Sample in Lab to Result Reporting | 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 |
| Time from Result Reporting to Patient Follow-up | 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 |
| Average Cycle Threshold Values by Genotype | 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 |
| Time from HPV Self-Collection to Receipt of Sample in Lab | 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 |
| HPV Test Validity | from specimen collection to receipt of results, up to 6 weeks | number of valid HPV test results / number of HPV tests |
Countries
Indonesia
Outcome results
None listed