Human Papilloma Virus (HPV)UnidosNCT06825689
Unidos Contra el VPH
A study testing Self-sampling with urine, Self-sampling with swab and In-clinic Pap/HPV co-testing in people with Human Papilloma Virus (HPV) and Cervical Cancers, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus (HPV), Cervical Cancers
- What is being tested?
- Self-sampling with urine, Self-sampling with swab and In-clinic Pap/HPV co-testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 735 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with a cervix who are 30-65 years and have not undergone a Pap test in at least three years.
Who cannot join
- Having had a hysterectomy or a personal history of cervical cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Project Vida Health Center
El Paso, Texas, 79905
Yanneth Rivera, MPH, 512-417-9617, yanneth.rivera@austin.utexas.edu
Mariah Alvarez, MPH, 915-308-1148, mariah.alvarez@austin.utexas.edu
About this study
Official title: Unidos Contra el VPH: Screening Preference and Uptake of HPV Self-sampling Among Latinxs Along the US-Mexico Border
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:
Read more
- How do the following three cervical cancer screening methods compare for improving screening completion rates?
- 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
- 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
- Being tested
- Self-sampling with urine, Self-sampling with swab, In-clinic Pap/HPV co-testing
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-sampling with urineDevice
Urine is self-collected at home using a urine sample cup.
Self-sampling with swabDevice
A vaginal cell sample is self-collected at home using a swab and collection tube.
In-clinic Pap/HPV co-testingDevice
Cervico-vaginal cell samples are collected by a clinician during a Pap smear/HPV co-test appointment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Urine Self-Sampling | Experimental | 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. Receives: Device: Self-sampling with urine |
| Group 2: Swab Self-Sampling | Experimental | 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. Receives: Device: Self-sampling with swab |
| Group 3: In-Clinic Co-Testing | Active comparator | Participants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment. Receives: Device: In-clinic Pap/HPV co-testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Completion Rates Among Three Cervical Cancer Screening Methods
This study will compare the effectiveness of three cervical cancer screening methods in achieving screening completion. Participants will be randomized to one of the following groups:
In-home HPV self-sampling using a urine sample In-home HPV self-sampling using a cervico-vaginal swab In-clinic cervical cancer screening via clinician-collected HPV and Pap test
The primary outcome will be the screening completion rate-- the proportion of participants who successfully complete their assigned screening method within the study period.
Measured: Screening completion within 60 days of enrollment
Secondary outcomes (1)
Comparison of Participant Beliefs and Preferences for HPV Self-Collection Versus Clinician-Collected Samples
We will assess participant beliefs and preferences regarding three cervical cancer screening methods: (1) in-home HPV self-sampling using urine, (2) in-home HPV self-sampling using a vaginal swab, and (3) in-clinic clinician-collected samples. Participants will complete surveys measuring their perceptions, acceptability, and preferences for the different screening options. The surveys include items based on Health Belief Model constructs such as perceived susceptibility, severity, benefits, barriers, and self-efficacy. Test preference will be measured on ease, pain, embarrassment, confidence in screening method, fear of harm, and convenience.
Measured: Participants will complete surveys at two time points: baseline (at enrollment) and follow-up (within 2 weeks of screening completion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start28 Jan 2025
- Primary completionOct 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus (HPV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 735 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center, El Paso
- Responsible party
- Principal investigator, Jessica Calderon-Mora, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825689
- Sponsor's protocol ID
- CPRIT-RP240208
- Other IDs
- STUDY00005986
- Acronym
- Unidos
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unidos Contra el VPH: Screening Preference and Uptake of HPV Self-sampling Among Latinxs Along the US-Mexico Border
- ClinicalTrials.gov ID
- NCT06825689
- Acronym / sponsor ID
- Unidos / CPRIT-RP240208
- Conditions
- Human Papilloma Virus (HPV), Cervical Cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 735 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center, El Paso
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do the following three cervical cancer screening methods compare for improving screening completion rates?
- 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
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Urine Self-Sampling | Experimental | Device: Self-sampling with urineParticipants 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. |
| Group 2: Swab Self-Sampling | Experimental | Device: Self-sampling with swabParticipants 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. |
| Group 3: In-Clinic Co-Testing | Active comparator | Device: In-clinic Pap/HPV co-testingParticipants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with a cervix who are 30-65 years and have not undergone a Pap test in at least three years.
Key exclusion criteria (1 listed)
- Having had a hysterectomy or a personal history of cervical cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-sampling with urineUrine is self-collected at home using a urine sample cup. | Device | Group 1: Urine Self-Sampling |
| Self-sampling with swabA vaginal cell sample is self-collected at home using a swab and collection tube. | Device | Group 2: Swab Self-Sampling |
| In-clinic Pap/HPV co-testingCervico-vaginal cell samples are collected by a clinician during a Pap smear/HPV co-test appointment. | Device | Group 3: In-Clinic Co-Testing |
Primary outcome
Comparison of Completion Rates Among Three Cervical Cancer Screening Methods
Time frame: Screening completion within 60 days of enrollment
This study will compare the effectiveness of three cervical cancer screening methods in achieving screening completion. Participants will be randomized to one of the following groups: In-home HPV self-sampling using a urine sample In-home HPV self-sampling using a cervico-vaginal swab In-clinic cervical cancer screening via clinician-collected HPV and Pap test The primary outcome will be the screening completion rate-- the proportion of participants who successfully complete their assigned screening method within the study period.
1 secondary outcome
Comparison of Participant Beliefs and Preferences for HPV Self-Collection Versus Clinician-Collected Samples
Time frame: Participants will complete surveys at two time points: baseline (at enrollment) and follow-up (within 2 weeks of screening completion).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-sampling with urine, Self-sampling with swab and In-clinic Pap/HPV co-testing in people with Human Papilloma Virus (HPV) and Cervical Cancers, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Calderón-Mora, DrPH (915-443-0272, jessica.calderonmora@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Completion Rates Among Three Cervical Cancer Screening Methods (time frame: Screening completion within 60 days of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.