Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing: Concurrence in Non-Clinical Settings vs. Clinical Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- Chlamydia trachomatis detected by nucleic acid amplification test in vaginal swabs
研究概览
简要总结
To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be compared to the result obtained with an SOVS collected in the clinic on multiple platforms (Direct Tube Sampling (DTS) / Panther / Tigris). The term "home-collected" is used to refer to any specimen that is not collected in a clinic, since there is no certainty that a specimen is collected "at home" or in a restroom in an office setting, etc. To compare the SOVS results to an FDA cleared predicate test with the collection of two clinician collected vaginal swabs.
详细描述
All potential participants enrolled in this study will undergo the following procedures:
- Informed consent (written) to participate in this study along with review of the Participant Information Sheet and Experimental Subject's Bill of Rights (per site requirements)
- Assessment of eligibility by nurse/clinician
- Collection of two SOVS in clinic
- Collection of two clinician collected vaginal swabs in the clinic
- Assessment of clinical signs or symptoms
- Group 1 - participants will collect two SOVS before clinic visit and deliver specimens to study staff at the clinic visit.
- Group 2 - participants will repeat collection of two SOVS at home after clinic visit and mail the specimens directly to the laboratory.
Clinical examinations will be conducted as appropriate to the reason for the visit/exam but the clinic procedures are not included as part of the protocol.
The enrollment strategy is designed to recruit a total of 3500 women with an average of 42-60 women per month over a 12-month recruitment period (500-700 women per site over the recruitment period). Participants will be seen and recruited in clinics at the participating STI-CTG, and other site clinics. At each participating clinical center, recruitment personnel will follow a site specific process that is designed to help identify potential participants. Only one visit is required to complete the study procedures. The total time required for a participant to complete this study may vary but is expected to be 45 minutes total time over 1 or 2 days. Intervals of several days between collection of the two specimens are likely for some women.
Clinic staff will approach women in the clinic or via phone and explain the object of the study and requirements of participation. The consenting process adopted by each site will be dependent on their IRB approval. Written consent will be obtained for all participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic and symptomatic females ages 16-75
- •Subjects scheduled for visits or presenting at Family Planning, OB/Gyn, STD or other clinics requesting (or candidates for) routine screening for Ct/GC
- •Willing to provide informed consent (written per site institutional review board approval)
排除标准
- •Inability to provide informed consent
- •Inability or unwillingness to collect a specimen at home (and mail it)
- •On antibiotic therapy within the last 30 days
- •Clinical conditions, such as cervicitis or pelvic inflammatory disease that would indicate presumptive treatment
- •Contact to person with Ct or GC in need of epidemiologic treatment
结局指标
主要结局
Chlamydia trachomatis detected by nucleic acid amplification test in vaginal swabs
时间窗: 24 hrs (at clinic visit)
AC2 testing on the DTS, Panther, and Tigris platforms for the presence or absence of Ct on "Home-collected" vs. "Clinic-collected" swab specimens, and clinician collected swabs.
次要结局
- Neisseria gonorrhoeae detected by nucleic acid amplification test in vaginal swabs(24 hrs (at clinic visit))