About this trial
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:
1. 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 2. 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.
Eligibility criteria
Qualifiers
Individuals with a cervix who are 30-65 years and have not undergone a Pap test in at least three years.
Disqualifiers
Having had a hysterectomy or a personal history of cervical cancer.
Trial design
Treatments tested in this trial
- Self-sampling with urine
- Self-sampling with swab
- In-clinic Pap/HPV co-testing
Treatment groups
Sponsors and collaborators
University of Texas at Austin
Lead sponsor
Texas Tech University Health Sciences Center, El Paso
Collaborator