A Pragmatic Randomized Control Trial Which Evaluates the Potential for HPV Self-testing to Promote Participation in Cervical Screening (PROMOTER) Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The total screening uptake rate in each arm
研究概览
简要总结
To explore the potential for vaginal self-sampling to increase participation in cervical screening, we offer the option of self-sampling to a group of non-participants in cervical screening (intervention), in addition to the routine screening (smear) test. Women in the control group will only receive the routine screening invitation letter. The total screening uptake rate, 2 months since the recruitment in each group will be compared.
详细描述
The aim of this research is to assess the feasibility of making vaginal self sampling available to women who have declined smear testing (defaulters), through the NHS to prevent cervical cancer. We plan to identify all defaulters living in Coventry between 30 and 40 years (n≈6000) from the cervical screening call-recall system. They will be randomized 1:1 to intervention and control arms. Women in the control arm will be sent a routine screening letter reminding them to have a smear test. Women in the intervention arm will be given the option of self-sampling for HPV testing, if they do not wish to have a smear test. They could order a self-HPV test by returning a slip in the pre-paid envelope. We then send the woman a vaginal self-collection kit. Self-collected sample will be returned to the laboratory for HPV testing. Whilst HPV positives (10-15%) will be advised to have a smear test, HPV negatives will be advised to accept their next smear test invitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All cervical screening programme defaulters living in Coventry
排除标准
- •Total hysterectomy (abdominal/laparoscopic/vaginal)
- •Never been sexually active/ intimate
- •Women who cannot give valid, informed, written consent
- •HPV self-sample returned without a signed consent form
- •Women who request the research team to be excluded from the trial
- •Women who have written to the Screening Services to record their refusal to take part in the NHSCSP
- •Women who are identified as becoming pregnant or undergoing hysterectomy following the initial test will be excluded from the analysis of data for secondary outcomes
结局指标
主要结局
The total screening uptake rate in each arm
时间窗: 2 months since the recruitment
In the experimental arm, the numerator will be the total number of smear tests + HPV self-tests. In the active control arm, it will be total number of smear tests.
次要结局
- Assess the women's attitude towards self-sampling and its feasibility(2 months since the recruitment)
- Proportion of smear positive women referred to colposcopy(1 month since the smear result)
- Proportion of women referred to colposcopy had attended colposcopy(3 months since the smear result)
- Proportion of HPV positive women who have subsequently had a smear test(2 months since the HPV test result)
- Proportion of women attended colposcopy had a CIN2+(4 months since the smear result)
- Assess the women's attitude towards the feasibility of self-sampling(2 months since the recruitment)