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临床试验/NCT07788599
NCT07788599尚未招募不适用

Renforcement, Orientation, Santé, Empowerment

University Hospital, Montpellier0 个研究点目标入组 200 人开始时间: 2026年9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
入组人数
200
主要终点
Care cascade following home self-sampling for STI screening

研究概览

简要总结

The goal of this interventional study is to describe the care pathway following the use of an innovative home self-sampling method for the screening of six sexually transmitted infections (STIs) among sex workers met during physical or virtual outreach activities conducted by the ROSELA programme of Médecins du Monde in Montpellier and the surrounding area.

The main questions it aims to answer are:

  • How many people are offered STI self-sampling, receive a self-sampling kit, and return the collected samples for laboratory testing
  • What proportion of participants are recontacted and attend a consultation following the screening results Participants will receive a self-sampling kit allowing them to collect samples at home or at a place of their choice and complete a questionnaire covering socio-demographic information and information related to their sex work activity.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being a sex worker or identifying as a sex worker
  • Being an adult (18 years or older)
  • Providing free and informed consent to participate in the study

排除标准

  • Inability to understand the study
  • Being under guardianship, curatorship or a future protection mandate
  • Participation in another research study with an exclusion period that is still ongoing at the time of pre-inclusion

结局指标

主要结局

Care cascade following home self-sampling for STI screening

时间窗: From study inclusion until completion of the care cascade, up to 3 months after inclusion

The care cascade will be assessed through the following steps: 1. \- number of people offered the self-sampling test 2. \- percentage of people who receive a self-sampling kit among those offered the test 3. \- percentage of people who return the self-sampling kit to the laboratory or hand it to the ROSELA team among those who received a kit 4. \- percentage of people who are successfully recontacted among those who returned the kit to the laboratory 5. \- percentage of people who attend a consultation among those who are recontacted and offered an appointment

次要结局

  • Reasons for refusal of the kit(At Inclusion)
  • Sociodemographic and clinical characteristics of the study population(At inclusion)
  • Screening for at least one of the six STIs before and during the intervention(At inclusion and through study completion, up to 3 months after inclusion)
  • Screening for each of the six STIs before and during the intervention(At inclusion and through study completion, up to 3 months after inclusion)
  • Number of outreach activities(Throughout the 1-year enrollment period)
  • Number of people involved in outreach activities(Throughout the 1-year enrollment period)
  • Prevalence of the six sexually transmitted infections(Up to 3 months after study inclusion)

研究者

申办方类型
Other
责任方
Sponsor

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