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临床试验/NCT05340322
NCT05340322已完成不适用

Closing the Gap Between Identification and Treatment of Cervical Abnormalities in Lima, Perú Through Integraton of Pocket Colposcopy, Telemedicine and Visual Counseling

Duke University1 个研究点 分布在 1 个国家目标入组 503 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
503
试验地点
1
主要终点
Number of HPV Positive Women Examined

研究概览

简要总结

The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. The objective is to provide colposcopy capability to rural communities in Peru potentially using Telehealth. Approximately 10,000 women will receive self HPV test kit for community health workers. Of these participants, approximately 1,000 HPV+ participants will be invited to participate in this pocket colposcopy study. Approximately 500 of these participants may require treatment using thermocoagulation.

详细描述

The goal is to demonstrate that the combination of self-sampling, the Pocket colposcope and the thermocoagulator will yield a high proportion of HPV positive women who complete treatment and follow-up care. The bulk of this trial will occur over a two-year period in Peru. Duke will provide the Pocket colposcope and the Calla application to run the device only. Dr. Garcia will recruit and train community women for the distribution of self-collection HPV test kits, identify and partner with 10 to 12 health centers in the Andean region of Peru, conduct baseline data collection in each health center, procure necessary equipment and technology, and conduct training for HPV testing, Pocket colposcopy, and thermocoagulation. Within 18 months trained community women will distribute 10,000 HPV tests to women within the region. The investigators anticipate that 10% of the women screened will be HPV positive and they will be recruited for our trial. As part of the study the participants will be followed to determine if the participants attend a health center, receive Pocket colposcopy, and if needed whether the participants are treated with the thermocoagulator device. All women will be appointed to return to the health center for a follow-up evaluation six months post-treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • HPV+ pap smear
  • Women must between the ages of 30-49yo

排除标准

  • HPV (-) pap smear
  • people without a cervix

结局指标

主要结局

Number of HPV Positive Women Examined

时间窗: up to approximately 1 year

Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope

次要结局

  • Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment(6 months after initial visit)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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