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NCT06825689 | RECRUITING | Human Papilloma Virus (HPV)


United against HPV
Sponsor:

University of Texas at Austin

Information provided by (Responsible Party):

Jessica Calderon-Mora

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.

Condition or disease

Human Papilloma Virus (HPV)

Cervical Cancers

Intervention/treatment

Self-sampling with urine

Self-sampling with swab

In-clinic Pap/HPV co-testing

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 735 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Unidos Contra el VPH: Screening Preference and Uptake of HPV Self-sampling Among Latinxs Along the US-Mexico Border
Actual Study Start Date : 2025-01-28
Estimated Primary Completion Date : 2028-10
Estimated Study Completion Date : 2029-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 65 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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.

United against HPV

Location Details

NCT06825689


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Texas

Project Life Health Center

The step, Texas, United States, 79905

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