Unidos Contra El VPH

Not Applicable

Recruiting

• Conditions: Human Papilloma Virus (HPV); Cervical Cancers

• Registration Number: NCT06825689
• Lead Sponsor: University of Texas at Austin

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-28
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2028-10
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 735

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of Completion Rates Among Three Cervical Cancer Screening Methods	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 Outcome Measures

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

Trial Locations

Locations (1)

Project Vida Health Center; 🇺🇸 El Paso, Texas, United States