HPV Self-sampling for Underscreened Latinas
September 1, 2026 updated by: Carolyn Fang, PhD, Fox Chase Cancer Center
Assessing the Feasibility and Acceptability of Juntas Contra el Virus Del Papiloma Humano, an HPV Self-sampling Intervention for Underscreened Latinas
The goal of this study is to learn if women of Hispanic/Latina ethnicity are willing to self-collect a cervico-vaginal sample for HPV testing. The main question the study will answer is:
• Does a brief educational intervention increase the feasibility and acceptability of HPV self-sampling among Hispanic/Latina women?
The study team will compare whether including a brief educational intervention with a mailed HPV self-sampling kit is more acceptable than receiving a mailed HPV self-sampling kit alone.
Participants will be asked to complete surveys at study entry (baseline) and then randomized to receive only the HPV self-sampling kit, or the kit plus a small group education that meets with a bilingual health educator.
Participants will then be contacted about one-month later to complete a follow-up survey. The study team will also measure the number of participants in each group who self-collect a sample and mail it in for HPV testing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study team will recruit a sample of underscreened Latinas (n=100) who will be randomly assigned to either the educational intervention (n=50) or a control condition (n=50).
Feasibility will be measured through study enrollment and intervention completion (defined as the proportion of women who self-collect a sample).
Acceptability of intervention materials and self-sampling procedures will be measured using self-report surveys at follow-up assessments.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Self-reported Hispanic/Latina ethnicity
- Assigned female sex at birth
- Age 30-65, consistent with guidelines for HPV DNA testing for cervical cancer screening
- Speak and read English or Spanish
- Computer or other device with internet connection
- Overdue for cervical cancer screening (e.g., no cytology-based screening within the past 3 years; no hrHPV testing either alone or in combination with cytology in the past 5 years).
Exclusion Criteria:
- Prior diagnosis of cervical cancer or abnormality (e.g., dysplasia)
- Had a hysterectomy/removal of the cervix
- Compromised immune system (e.g., known HIV)
- Women who self-report that they are pregnant or are within three months after a pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mailed Kit Only Control
Participants receive an HPV self-sampling kit in the mail with instructions on how to self-collect a sample and return it to the lab for testing.
|
HPV self-sampling kit
|
|
Experimental: Education Plus Mailed Kit
Participants receive information about cervical cancer risks and screening guidelines in a small-group format with a bilingual health educator.
Participants also receive an HPV self-sampling kit in the mail with instructions on how to self-collect a sample and return it to the lab for testing.
|
HPV self-sampling kit
Small-group education led by bilingual health educator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Feasibility
Time Frame: 1 month
|
The number of participants in the intervention arm who attend at least one session
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation in screening
Time Frame: 1 month
|
The number of participants who return a self-collected sample
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn Fang, PhD, Fox Chase Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2023
Primary Completion (Actual)
September 30, 2024
Study Completion (Actual)
September 30, 2024
Study Registration Dates
First Submitted
May 28, 2024
First Submitted That Met QC Criteria
May 28, 2024
First Posted (Actual)
June 3, 2024
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
September 1, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Uterine Cervical Neoplasms
Other Study ID Numbers
- 23-1027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
De-identified data and associated documentation can be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
All procedures will be compliant with NIH regulations on the distribution of unique research resources.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.