Unidos Contra el VPH: Screening Preference and Uptake of HPV Self-sampling Among Latinxs Along the US-Mexico Border
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 735
- 试验地点
- 2
- 主要终点
- Comparison of Completion Rates Among Three Cervical Cancer Screening Methods
研究概览
简要总结
The purpose of the Unidos Contra el VPH study is to help find options to screen, or check, for cervical cancer that individuals can do at home to help prevent and detect cervical cancer early. Usually, people get screened for cervical cancer with a Pap smear and human papillomavirus (HPV) test by a health care provider. This is not always easy for individuals who are not able to get to a clinic or feel uncomfortable having the procedure done. That is why we want to find other ways that may be easier and more comfortable for people to be screened for cervical cancer.
The two main questions the study aims to answer are:
- How do the following three cervical cancer screening methods compare for improving screening completion rates?
o In-home HPV self-sampling with a vaginal swab
- In-home HPV self-sampling with urine testing
- In-clinic traditional Pap smear with HPV test
- What are participant beliefs and preferences regarding these three screening methods?
Participants in the study will be randomly assigned to one of three groups. This means each person has an equal chance of being placed in any group. They will also complete two surveys as part of the study. The three screening method groups are described below:
Group 1: Urine Self-Sampling
- Participants in this group will receive a kit with a urine sample cup to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the urine sample to the lab.
Group 2: Vaginal Swab Self-Sampling o Participants in this group will receive a kit with a vaginal swab and collection tube to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the sample to the lab.
Group 3: In-Clinic Screening
- An in-clinic co-testing appointment is scheduled for a Pap smear and HPV test done together at Project Vida Health Center.
By comparing these approaches, this study aims to improve access to cervical cancer screening and provide better options for those who face barriers to clinic-based screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals with a cervix who are 30-65 years and have not undergone a Pap test in at least three years.
排除标准
- •Having had a hysterectomy or a personal history of cervical cancer.
研究组 & 干预措施
Group 2: Swab Self-Sampling
Participants in this group receive a kit with a vaginal swab and collection tube to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the sample to the lab.
干预措施: Self-sampling with swab (Device)
Group 1: Urine Self-Sampling
Participants in this group receive a kit with a urine sample cup to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the urine sample to the lab.
干预措施: Self-sampling with urine (Device)
Group 3: In-Clinic Co-Testing
Participants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment.
干预措施: In-clinic Pap/HPV co-testing (Device)
结局指标
主要结局
Comparison of Completion Rates Among Three Cervical Cancer Screening Methods
时间窗: Screening completion within 60 days of enrollment
This study will compare the effectiveness of three cervical cancer screening methods in achieving screening completion. Participants will be randomized to one of the following groups: In-home HPV self-sampling using a urine sample In-home HPV self-sampling using a cervico-vaginal swab In-clinic cervical cancer screening via clinician-collected HPV and Pap test The primary outcome will be the screening completion rate-- the proportion of participants who successfully complete their assigned screening method within the study period.
次要结局
- Comparison of Participant Beliefs and Preferences for HPV Self-Collection Versus Clinician-Collected Samples(Participants will complete surveys at two time points: baseline (at enrollment) and follow-up (within 2 weeks of screening completion).)
研究者
Jessica Calderon-Mora
Assistant Professor
University of Texas at Austin