Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| STUDY00005986 | Other Identifier | University of Texas at Austin Dell Medical School |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Texas Tech University Health Sciences Center, El Paso | OTHER |
Not provided
Not provided
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?
o In-home HPV self-sampling with a vaginal swab
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
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Group 3: In-Clinic Co-Testing | Active Comparator | Participants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-sampling with urine | Device | Urine is self-collected at home using a urine sample cup. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening completion within 60 days of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Calderón-Mora, DrPH | Contact | 915-443-0272 | jessica.calderonmora@austin.utexas.edu | |
| Yanneth Rivera, MPH | Contact | 512-417-9617 | yanneth.rivera@austin.utexas.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Vida Health Center | Recruiting | El Paso | Texas | 79905 | United States |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Self-sampling with swab | Device | A vaginal cell sample is self-collected at home using a swab and collection tube. |
|
| In-clinic Pap/HPV co-testing | Device | Cervico-vaginal cell samples are collected by a clinician during a Pap smear/HPV co-test appointment. |
|
| Participants will complete surveys at two time points: baseline (at enrollment) and follow-up (within 2 weeks of screening completion). |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |