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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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The purpose of this study is to implement human papillomavirus (HPV) self-collection in Indonesia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Self-Collection | Experimental | Participants will perform HPV self-collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Self-Collection | Diagnostic Test | Participants will perform HPV self-collection. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| HPV Self-Collection Participation Rate |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Widyorini L Hanafi, MD | Dharmais National Cancer Center Hospital | Principal Investigator |
| Dian T Sinulingga, MD, M.Epid | Dharmais National Cancer Center Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puskesmas Lebak | Lebak | Banten | Indonesia | |||
| Dharmais National Cancer Center Hospital |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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number of subjects with samples received at the laboratory / number of invited subjects |
| 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 |
| 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 |
| Jakarta |
| Jakarta Special Capital Region |
| 11420 |
| Indonesia |
| Puskesmas Depok | Depok | West Java | Indonesia |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |