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
- 4
- 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
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)