Unidos Contra el VPH

NCT06825689 | Recruiting FDA Device

• 2 other identifiers: CPRIT-RP240208STUDY00005986
• Study Type: interventional
• Target: 735
• Locations: 1 country
• Sites: 1

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:

• In-home HPV self-sampling with urine testing
• In-clinic traditional Pap smear with HPV test
• What are participant beliefs and preferences regarding these three screening methods?
• 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.

Conditions

Human Papilloma Virus (HPV); Cervical Cancers

Outcome Measures

Primary Outcomes (1)

• Comparison of Completion Rates Among Three Cervical Cancer Screening Methods

  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.

  Screening completion within 60 days of enrollment

Secondary Outcomes (1)

• 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).

Study Arms (3)

Group 1: Urine Self-Sampling

EXPERIMENTAL

Participants in this group 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.

Device: Self-sampling with urine

Group 2: Swab Self-Sampling

EXPERIMENTAL

Participants in this group 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.

Device: Self-sampling with swab

Group 3: In-Clinic Co-Testing

ACTIVE COMPARATOR

Participants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment.

Device: In-clinic Pap/HPV co-testing

Interventions

Self-sampling with urine DEVICE

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

Group 1: Urine Self-Sampling

Self-sampling with swab DEVICE

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

Group 2: Swab Self-Sampling

In-clinic Pap/HPV co-testing DEVICE

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

Group 3: In-Clinic Co-Testing

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Texas Tech University Health Sciences Center, El Paso: collaborator

Study Sites (1)

Project Vida Health Center

El Paso, Texas, 79905, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Jessica Calderón-Mora, DrPH

CONTACT

915-443-0272; jessica.calderonmora@austin.utexas.edu

Yanneth Rivera, MPH

CONTACT

512-417-9617; yanneth.rivera@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: January 28, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 13, 2025

Record last verified: 2025-01

Locations

US (1)