Feasibility of Community-based Distribution of HPV Self-Collection Kits for At Home Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of participants who returned HPV samples
研究概览
简要总结
This study is testing and implementing an equity-focused, community-based intervention that improves women's access to cervical cancer screening and adherence to follow up after an abnormal result. The study's objective is to assess and compare the feasibility of different methods of distributing at-home HPV testing kits for cervical cancer screening among individuals who are under-screened.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Are age 25 or older
- •Has an intact cervix
- •Self-reports that they have not been screened for cervical cancer within the last 3 years for 25-64, 5 years for 65 or older
- •Has a cellphone that can receive texts (including verification codes) and an email account
- •Has access to the internet to engage with the Teal Health mobile app and complete a Zoom interview
- •Can read, speak, write and understand English well enough to take a survey and complete an interview
排除标准
- •Abnormal vaginal bleeding or discharge
- •A history of cancer of the reproductive system
- •A compromised immune system
- •Prior Diethylstilbestrol (DES) exposure
- •Currently pregnant or are within 6 weeks of giving birth
- •Treatment for a cervical precancer (e.g., loop electrosurgical excision procedure or conization) in the last 25 years.
研究组 & 干预措施
Aim 1: Standard instructions
Participants will complete a sociodemographic questionnaire and will receive the standard instructions. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.
干预措施: Qualitative Interview (Behavioral)
Aim 1: Standard instructions
Participants will complete a sociodemographic questionnaire and will receive the standard instructions. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.
干预措施: Virtual Visit Standard Instructions (Behavioral)
Aim 1: Standard instructions + in-person guidance
Participants will complete a sociodemographic questionnaire and will receive the standard instructions and in-person navigation for registering for a consult to receive the at-home testing kit. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.
干预措施: Qualitative Interview (Behavioral)
Aim 1: Standard instructions + in-person guidance
Participants will complete a sociodemographic questionnaire and will receive the standard instructions and in-person navigation for registering for a consult to receive the at-home testing kit. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.
干预措施: Virtual Visit Standard Instructions + In-Person Registration Navigation (Behavioral)
结局指标
主要结局
Proportion of participants who returned HPV samples
时间窗: Up to eight weeks after enrollment
Feasibility of the distribution methods between groups will be measured by the return rate of at home, self-collected HPV samples. Outcome will be reported via Pearson's chi-square test.
Proportion of participants with completed referral visits
时间窗: Up to eight weeks after enrollment
Outcome will be reported via Pearson's chi-square test.
Time to sample return
时间窗: Up to eight weeks after enrollment
Outcome will be analyzed by nominal regression model.
Time to referral
时间窗: Up to eight weeks after enrollment
Outcome will be analyzed by nominal regression model.
Thematic findings addressing opportunity
时间窗: Eight weeks after enrollment
Will be assessed during semi-structured interviews with participants and analyzed according to the Capability, Opportunity, Motivation, Behavior (COM-B) model. Questions during the semi-structure interview will follow a guide. Answers to the questions will be analyzed for thematic findings. The following questions on the guide asked to the returners of kits: * What was your reaction for when you were offered the Teal kit? * How did the support from event staff, the virtual care visit, or people in your life influence your decision about using the kit? The following questions on the guide asked to the non-returners of kits: * What, if any, were the barriers that prevented you from completing it? \*Probe: For example, finding the time to use the kit or understanding the instructions * Was there anything that changed between the time you enrolled in the study and receiving the kit that made you decide to not complete the kit?
Thematic findings addressing capability
时间窗: Eight weeks after enrollment
Will be assessed during semi-structured interviews with participants \& analyzed according to the COM-B model. Questions during the semi-structure interview will follow a guide. Answers will be analyzed for thematic findings. The following will be asked to returners of kits: * How confident are you in the results you received? Do you trust them? Why/why not? * Did you feel like you received enough information when you got the kit to know what to do? * How did you feel about your ability to correctly use the self-sampling kit? * Were there any physical difficulties or health issues that made it challenging for you to use the kit? If so, can you describe them? * Do you have any recommendations for improving access to Teal kits for at-home cervical cancer screening? The following will be asked to non-returners of kits: * What suggestions/changes do you think would make it easier for you to use the kit in the future?
Thematic findings addressing motivation
时间窗: Eight weeks after enrollment
Will be assessed during semi-structured interviews with participants \& analyzed according to COM-B model. Questions will follow a guide. Answers will be analyzed for thematic findings. The following will be asked to returners of kits: * Feelings about cervical cancer screening? * Previous pap smear/HPV test for cervical cancer screening? Describe the experience. * Any concerns/uncertainties you had about using the kit? * What made you decide to use the kit? * What did you like/not like about using the kit? * What things got in the way of using the kit or made it easier? * Would you recommend the kit to a friend? * Would you use the kit in the future? * Thoughts on the importance/urgency of completing the kit? * Explanation of your beliefs about the potential benefits/downsides of using the kit? The following will be asked to non-returners of kits: -Can you describe any situations/experiences/barriers that influenced your decision not to complete \& return the kit?
Thematic findings addressing behavior
时间窗: Eight weeks after enrollment
Will be assessed during semi-structured interviews with participants and analyzed according to the COM-B model. Questions during the semi-structure interview follow a guide. Answers to the questions will be analyzed for thematic findings. The following questions on the guide asked to all participants: -Before receiving the kit, what were some of the reasons you were overdue for cervical cancer screening?
次要结局
- Proportion of participants with positive results who completed follow-up(Up to eight weeks after results available)