HPV DNA Screening With Self-Collection Method and Its Management in the Context of Population-Based Cervical Cancer Screening Pilot Project in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 8,000
- 试验地点
- 3
- 主要终点
- Success Rate of HPV Self-Collection
研究概览
简要总结
The purpose of this study is to implement human papillomavirus (HPV) self-collection in Indonesia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HPV Self-Collection
Participants will perform HPV self-collection.
干预措施: HPV Self-Collection (Diagnostic Test)
结局指标
主要结局
Success Rate of HPV Self-Collection
时间窗: 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
次要结局
- 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)
- HPV Self-Collection Participation Rate(from enrollment to receipt of results, up to 8 weeks)
- HPV Self-Collection Invitation Coverage(from enrollment to receipt of results, up to 8 weeks)
- 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)
- Patient Follow-up Rate(from receipt of results to follow-up exam, up to 60 days)