Clinical trial NCT06825689: Unidos Contra el VPH
Official title: Unidos Contra el VPH: Screening Preference and Uptake of HPV Self-sampling Among Latinxs Along the US-Mexico Border
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papilloma Virus (HPV)
Cervical Cancers
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Texas Tech University Health Sciences Center, El Paso
First posted: 2025-02-13
Enrollment: 735
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility 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.

Primary outcomes:
measure: Comparison of Completion Rates Among Three Cervical Cancer Screening Methods
timeFrame: Screening completion within 60 days of enrollment
Secondary outcomes:
measure: Comparison of Participant Beliefs and Preferences for HPV Self-Collection Versus Clinician-Collected Samples
timeFrame: Participants will complete surveys at two time points: baseline (at enrollment) and follow-up (within 2 weeks of screening completion).
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Project Vida Health Center
state: Texas
Study officials:
References: