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)
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
- 是
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
Thesla Palanee-Phillips
Director of Clinical Trials
Wits RHI Research Centre Clinical Research Site
