跳至主要内容
临床试验/NCT06566677
NCT06566677已完成不适用

Validation of Selected Point of Care Rapid STI Diagnostic Tests for Laboratory Based and Self- Test Use - A Sub-Study of Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expanded Partner Therapy (EPT) (ARISE)

Wits RHI Research Centre Clinical Research Site1 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2023年1月26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
364
试验地点
1
主要终点
GeneXpert

研究概览

简要总结

The purpose of this sub-study (PROVE) is to support and facilitate the validation of commercially available point of care (POC) sexually transmitted infection (STI) diagnostic test kits/devices for potential on-site laboratory use as well as bedside use in parallel to gold standard established testing methodologies. A further extension of bedside testing would include self-testing.

详细描述

Screening and Enrolment procedures for the ARISE study (HREC Ref No. 210614) involves adolescent girls and young women (AGYW) being screened for Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) as determined through testing of clinician-collected genital swabs followed by GeneXpert, OSOM rapid TV testing or through wet mount visualisation of the micro-organisms of interest. This will generate a pool of AGYW with known STI diagnoses who, if positive, will be treated on-site on the day of STI detection. It will also create an ideal opportunity to leverage access to samples from willing participants (prior to STI treatment if STI positive) for validation of a range of alternate STI test kits. Samples provided will enable same-day parallel testing on additional platforms for validation of the sensitivity and specificity of these alternate tests against the known validated platformsThis initiative will expand the menu of cost effective and user friendly STI test kits that may ultimately be used in other research studies, in public clinic settings and as self-tests performed discretely in the convenience and privacy of one's home.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants must meet the following criteria to be eligible for inclusion in the study:
  • Cisgender adolescent girls and young women (18-25 years of age, inclusive), screened for or enrolled in the ARISE study.
  • Willing to provide written informed consent to participate in this sub-study.
  • Willing to provide additional samples including vaginal and endocervical swabs, urine and those collected through the use of tampons and disposable menstrual cups.

排除标准

  • Cisgender male or transgender woman or transgender man
  • Age <18 years
  • Unable or unwilling to provide written informed consent
  • Have any condition that in the opinion of the investigators will interfere with successful completion of sub-study procedures

结局指标

主要结局

GeneXpert

时间窗: 1 year

A PCR instrument was used to assess the presence of chlamydia trichomatis and gonorrhea from samples taken using endocervical swabs.

次要结局

  • Osom rapid testing kit(1 year)

研究者

发起方
Wits RHI Research Centre Clinical Research Site
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thesla Palanee-Phillips

Director of Clinical Trials

Wits RHI Research Centre Clinical Research Site

研究点 (1)

Loading locations...

相似试验

Point of Care Rapid STI Test Optimization and... | 临床试验