Unidos Contra El VPH

Last updated: February 7, 2025
Sponsor: University of Texas at Austin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Human Papilloma Virus (Hpv)

Treatment

Self-sampling with swab

Self-sampling with urine

In-clinic Pap/HPV co-testing

Clinical Study ID

NCT06825689
CPRIT-RP240208
STUDY00005986
  • Ages 30-65
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 735
Treatment Group(s): 3
Primary Treatment: Self-sampling with swab
Phase:
Study Start date:
January 28, 2025
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Project Vida Health Center

    El Paso, Texas 79905
    United States

    Active - Recruiting

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