| NCT ID | NCT06825689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Human Papilloma Virus (HPV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 735 participants |
| Start Date | 2025-01-28 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 735 participants in total. It began in 2025-01-28 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06825689 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 65 Years, studying Human Papilloma Virus (HPV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06825689 currently recruiting?
Yes, NCT06825689 is actively recruiting participants. Contact the research team at jessica.calderonmora@austin.utexas.edu for enrollment information.
Where is the NCT06825689 trial being conducted?
This trial is being conducted at El Paso, United States.
Who is sponsoring the NCT06825689 clinical trial?
NCT06825689 is sponsored by University of Texas at Austin. The trial plans to enroll 735 participants.