Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
735 participants
INTERVENTIONAL
2025-01-28
2029-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
Self-sampling with urine
Urine is self-collected at home using a urine sample cup.
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.
Self-sampling with swab
A vaginal cell sample is self-collected at home using a swab and collection tube.
Group 3: In-Clinic Co-Testing
Participants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment.
In-clinic Pap/HPV co-testing
Cervico-vaginal cell samples are collected by a clinician during a Pap smear/HPV co-test appointment.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
65 Years
FEMALE
Yes
Sponsors
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Texas Tech University Health Sciences Center, El Paso
OTHER
University of Texas at Austin
OTHER
Responsible Party
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Jessica Calderon-Mora
Assistant Professor
Locations
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Project Vida Health Center
El Paso, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00005986
Identifier Type: OTHER
Identifier Source: secondary_id
CPRIT-RP240208
Identifier Type: -
Identifier Source: org_study_id
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