Unidos Contra El VPH

The University of Texas System (UT)

Status: Enrolling

Conditions: Human Papilloma Virus (HPV); Cervical Cancers

Treatments: Device: In-clinic Pap/HPV co-testing; Device: Self-sampling with urine; Device: Self-sampling with swab

Study type: Interventional

Funder types: Other

Identifiers

NCT06825689

STUDY00005986 (Other Identifier)

CPRIT-RP240208

Details and patient eligibility

About

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.

Enrollment: 735 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals with a cervix who are 30-65 years and have not undergone a Pap test in at least three years.

Exclusion criteria

• Having had a hysterectomy or a personal history of cervical cancer.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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735 participants in 3 patient groups

Group 1: Urine Self-Sampling

Experimental group

Description:

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.

Treatment:

Device: Self-sampling with urine

Group 2: Swab Self-Sampling

Experimental group

Description:

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.

Treatment:

Device: Self-sampling with swab

Group 3: In-Clinic Co-Testing

Active Comparator group

Description:

Participants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment.

Treatment:

Device: In-clinic Pap/HPV co-testing