Meatal Swab Yourself With Testing for Infections Collectively (MYSTIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,250
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity for gonorrhoea, chlamydia and LGV diagnosis using NAATS
研究概览
简要总结
The goal of this study is
- to improve the accuracy of chlamydia multi-site testing in men who have sex with men (MSM) and trans-women, whilst saving diagnostic costs, by comparing two new pooling methods with the 3-samples tested separately
- to assess the diagnostic accuracy of pooled specimens for lymphogranuloma venereum detection (LGV) - a type of chlamydia infection
Chlamydia and gonorrhoea testing for MSM and trans-women usually involves 3 samples from the throat, bum and wee-pipe. The tests can be combined into a single sample pot (pooled sample) which reduces costs, but in a previous study this reduced the accuracy for finding chlamydia.
The main question for this study is:
Can the accuracy of chlamydia testing in a pooled sample be improved by reducing the amount of urine added to minimise dilution, or by using a meatal sample instead of a urine sample?
Participants will be asked to complete two sets of their own throat and bum samples, and then combine these into two pooled samples with 1)a meatal swab and 2)a smaller amount of first catch urine. The order of these samples will be randomised. These samples will be compared against separate samples taken at the same visit, to see how accurate the pooled samples are at diagnosing chlamydia and gonorrhoea with the different sampling techniques.
详细描述
Testing for chlamydia and gonorrhoea in men who have sex with men (MSM) and trans-women is recommended every three months for those taking HIV Pre-Exposure Prophylaxis (PrEP). Testing requires throat and bottom samples, and samples from the urethra (wee-pipe), usually a urine sample. However, many sexual health services struggle to afford the costs of these 3-samples, four-times per year, which may restrict numbers given PrEP.
The investigators' previous research has shown that the 3-samples (throat, bottom, urine) can be combined into one pooled specimen to accurately find gonorrhoea and reduce laboratory costs. However, the chlamydia results of pooled samples were not as good, finding only 92 out of 100 infections compared with 99 out of 100 with 3 separate samples. The investigators' past research showed no difference in diagnostic accuracy between clinician and self-taken rectum and pharynx swabs for NG and CT detection. People prefer to take their own swabs and self-taken swabs were more cost effective than clinician taken. Self-taken swabs are now used routinely in clinical practice and are available as on-line ordered commercial kits.
This study aims to improve the accuracy of chlamydia results by comparing two new pooling methods with the 3-samples tested separately.
MSM, and trans-women, aged 18 years or over, attending a large UK city sexual health service for chlamydia and gonorrhoea testing will be invited to take part in the study.
The pooling methods will be: 1) pooling with a smaller amount of urine to reduce the dilution of the other samples; and 2) pooling with a swab sample from the outside of the tip of the penis (meatal swab) instead of urine. Meatal swabs are taken by the person themselves. The swab does not go inside the penis so is easy to do and not painful. Studies suggest meatal swabs may be better at finding chlamydia than urine samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Laboratory staff will be masked and will not be able to link pooled samples (sent under a unique study number) to comparator standard care separate samples (sent under a unique patient identifier).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years and over. Willing to perform self-taken swabs in addition to any clinician required swabs. Able to provide informed consent
排除标准
- •Antibiotics taken in the past 14 days (excluding metronidazole). Previous participation in this trial
结局指标
主要结局
Sensitivity and specificity for gonorrhoea, chlamydia and LGV diagnosis using NAATS
时间窗: 14 months
To improve the accuracy of chlamydia diagnoses in MSM and trans-women by comparing two new pooling methods with the 3-samples tested separately, and to assess the diagnostic accuracy of pooled specimens for lymphogranuloma venereum detection (LGV) - a type of chlamydia infection
次要结局
- Participant satisfaction with using meatal swabs compared with first catch urine for the diagnosis of gonorrhoea, chlamydia, and LGV as measured by a Likert scale(14 months)
- Participant satisfaction with taking and pooling combined site samples, compared with individually analysed samples for the diagnosis of gonorrhoea, chlamydia, and LGV as measured by a Likert scale(14 months)