NCT06825689 · University of Texas at Austin
Unidos Contra el VPH
(Unidos)
What this study is 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.
View original scientific description
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.
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- El Paso, Texas
Collaborators
Texas Tech University Health Sciences Center, El Paso
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations