Recruiting

VPH

Sponsor:

University of Texas at Austin

Code:

NCT06825689

Conditions

Human Papilloma Virus (HPV)

Cervical Cancers

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

Interventions

Self-sampling with urine

Self-sampling with swab

In-clinic Pap/HPV co-testing

Study Details

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.

Conditions

Human Papilloma Virus (HPV)

Cervical Cancers

Study ID

NCT06825689

Start date

Jan 28, 2025

Status verified date

Mar, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

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

Enrollment

735 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Self-sampling with urine

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

Self-sampling with swab

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

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 measure

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

Central Contacts and Locations

Central contacts

Jessica Calderón-Mora, DrPH

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

Yanneth Rivera, MPH

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

Locations

Project Vida Health Center

Recruiting

El Paso, Texas, United States, 79905

Contacts

Yanneth Rivera, MPH

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

Mariah Alvarez, MPH

915-308-1148mariah.alvarez@austin.utexas.edu

Principal Investigator:

Jessica Calderón-Mora, DrPH

More Information

Sponsor

University of Texas at Austin

Last update posted

Jun 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-06-10.