Unidos Contra el VPH

Part of paid clinical trials in El Paso, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT06825689
Status
Recruiting
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Conditions

  • Cervical Cancers
  • Human Papilloma Virus (HPV)

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 28, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
735 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Group 1: Urine Self-Sampling
    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.
  • Experimental: Group 2: Swab Self-Sampling
    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.
  • Active Comparator: Group 3: In-Clinic Co-Testing
    Participants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment.

Primary Outcome Measure

Comparison of Completion Rates Among Three Cervical Cancer Screening Methods [ Time Frame: Screening completion within 60 days of enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Project Vida Health CenterEl PasoTexas79905
Yanneth Rivera, MPH
[email protected]
512-417-9617
Mariah Alvarez, MPH
[email protected]
915-308-1148
Jessica Calderón-Mora, DrPH (PRINCIPAL_INVESTIGATOR)

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Project Vida Health Center· El Paso, TX

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