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NCT Number: NCT06825689

Unidos Contra el VPH

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.

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Key information

Conditions

Human Papilloma Virus (HPV) Cervical Cancers Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-sampling with urine

Device

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

Self-sampling with swab

Device

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

In-clinic Pap/HPV co-testing

Device

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

Primary outcomes

  1. Comparison of Completion Rates Among Three Cervical Cancer Screening Methods

    Time frame: 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.

Secondary outcomes

  1. Comparison of Participant Beliefs and Preferences for HPV Self-Collection Versus Clinician-Collected Samples

    Time frame: Participants will complete surveys at two time points: baseline (at enrollment) and follow-up (within 2 weeks of screening completion).

    We will assess participant beliefs and preferences regarding three cervical cancer screening methods: (1) in-home HPV self-sampling using urine, (2) in-home HPV self-sampling using a vaginal swab, and (3) in-clinic clinician-collected samples. Participants will complete surveys measuring their perceptions, acceptability, and preferences for the different screening options. The surveys include items based on Health Belief Model constructs such as perceived susceptibility, severity, benefits, barriers, and self-efficacy. Test preference will be measured on ease, pain, embarrassment, confidence in screening method, fear of harm, and convenience.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Calderón-Mora, DrPH

CONTACT

[email protected]

915-443-0272

Yanneth Rivera, MPH

CONTACT

[email protected]

512-417-9617

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Texas Tech University Health Sciences Center, El Paso

Registry information

Official study title

Unidos Contra el VPH: Screening Preference and Uptake of HPV Self-sampling Among Latinxs Along the US-Mexico Border

Acronym: Unidos

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 13, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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