NCT06656611尚未招募不适用
PAPMOBILE: Mobile Outreach Screening of High-Risk Human Papillomavirus Infection in Women with Limited Access to Health Services in Seine-Saint-Denis (greater Paris Area, France)
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Total number and proportion of eligible women (age 30 to 65, unscreened for cervical cancer for 3 to 5 years) who had an HPV PCR test on a self-collected vaginal sample when offered in a nonclinical setting by the Bus Santé de Seine-Saint-Denis
研究概览
简要总结
The study is a prospective cervical cancer screening intervention in the nonclinical setting of a mobile testing unit in a vehicle, using point-of-care HPV PCR tests with self-collected vaginal swabs.
It is designed for women with limited access to healthcare and prevention in underprivileged municipalities in the greater Paris area (Seine-Saint-Denis department, detailed in Annexe 3).
HPV positive participants will receive counseiling and guidance to help them find a healthcare professional to take care of their needs
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- Women from 30 to 65 years of age presenting to the " Bus Santé " nonclinical testing unit, eligible to cervical cancer screening by an HPV-HR test
- •Women affiliated to the French social security or immigrants benefiting from the state medical aid program for undocumented immigrants (Aide Médicale d'Etat). The inclusion of people not affiliated to a social security system is an exception and depends on the decision of the Personal Protection Committee, if it is based on an expected benefit for these people of a nature to justify the foreseeable risk incurred.
- •The intervention is designed for vulnerable women with limited access to healthcare, including but not limited to:
- •Women living in shelters and hostels, women living in the streets, in squats, hot-bedding arrangements, emergency social housing;
- •Recent immigrants, documented or undocumented;
- •Young adults from priority neighbourhoods,
- •Isolated or marginalized women
- •Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any sampling carried out as part of the trial (article L1122-1-1 of the Public Health Code)
- •The Bus will operate in underprivileged neighbourhoods in the greater Paris area (eastern Seine-Saint-Denis department.
排除标准
- •Screened for cervical cancer by a PAP smear in the last 3 years or by an HPV test in the last 5 years,
- •Women on their period (haemoglobin inhibits PCRs)
- •Pregnancy in the 2nd and 3rd trimesters
- •Total hysterectomy; absence of a vagina
- •Women under guardianship/tutelage
结局指标
主要结局
Total number and proportion of eligible women (age 30 to 65, unscreened for cervical cancer for 3 to 5 years) who had an HPV PCR test on a self-collected vaginal sample when offered in a nonclinical setting by the Bus Santé de Seine-Saint-Denis
时间窗: Day 0
次要结局
- Declined to participate: number and why(Day 0)
- Description of the barriers to cervical cancer screening in the target population(Day 0)
- Proportion of complete HPV-HR PCRs run onboard the Bus and proportion with same-day results available to the participants(Day 0)
- Frequency of positive HPV-HR tests and of invalid HPV-HR tests using SCVS samples(Day 0)
- Description of HPV types in the participant population(Day 0)
- Comparison of HPV-HR negative and HPV-HR positive participants(Day 0)
- Proportion of secondary pelvic examination and cervical PAP smears in HPV-positive participants ; in Step 1 (laboratory-based PCR) and Step 2 (PCR aboard the Bus with same-day results)(Day 0)
- Proportion of Chlamydiae trachomatis and Neisseria gonorrhoea STIs(Day 0)
- Number and frequency of cytological abnormalities and cervical lesions in participants who had a PAP smear following a positive HPV-HR test ; in Step 1 (laboratory-based PCR) and Step 2 (PCR aboard the Bus with same-day results)(Day 0)
- Proportion of valid self-collected vaginal swabs (cellular density, valid HPV PCR)(Day 0)
- Unavailability of point-of-care HPV-HR PCR: number of days and why (reagent shortage, instrument of power failure, environmental conditions, short-staffing…)(Day 0)
- Reliability of vaginal self-sampling in a nonclinical setting: proportion of valid samples, types of non-conformity(Day 0)
- Participant satisfaction with point-of-care self-sampling and HPV testing; proportion willing to recommend the intervention to their acquaintance(Day 0)
- Staff satisfaction by self-questionnary(Day 0)
- Adverse events; setbacks and adjustments over the study period(From day 0 to the last call (about month 2))
研究者
研究点 (2)
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