Unidos Contra el VPH

Summary

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.

Conditions

• Human Papilloma Virus (HPV)
• Cervical Cancers

Interventions

DEVICE

Self-sampling with urine

Urine is self-collected at home using a urine sample cup.

DEVICE

Self-sampling with swab

A vaginal cell sample is self-collected at home using a swab and collection tube.

DEVICE

In-clinic Pap/HPV co-testing

Cervico-vaginal cell samples are collected by a clinician during a Pap smear/HPV co-test appointment.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso

  collaborator OTHER

• University of Texas at Austin

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-28

Primary Completion

2028-10-31

Completion

2029-02-28

FDA Device

Yes

Countries

• United States

Study Locations