Uterine Cervical NeoplasmNCT06439706
HPV Self-sampling for Underscreened Latinas
A study testing HPV Self-Sampling and Group Education in people with Uterine Cervical Neoplasm, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
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?… 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
- Uterine Cervical Neoplasm
- What is being tested?
- HPV Self-Sampling and Group Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Uterine Cervical Neoplasm
- Being tested
- HPV Self-Sampling, Group Education
- 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.
HPV Self-SamplingBehavioural
HPV self-sampling kit
Group EducationBehavioural
Small-group education led by bilingual health educator
| Study group | Role | What they receive |
|---|---|---|
| Mailed Kit Only Control | Active comparator | 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. Receives: Behavioral: HPV Self-Sampling |
| Education Plus Mailed Kit | Experimental | 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. Receives: Behavioral: HPV Self-Sampling; Behavioral: Group Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
The number of participants in the intervention arm who attend at least one session
Measured: 1 month
Secondary outcomes (1)
Participation in screening
The number of participants who return a self-collected sample
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start4 Oct 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Fang, PhD, Fox Chase Cancer Center
- Investigators
- Carolyn Fang, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439706
- Sponsor's protocol ID
- 23-1027
- Status last verified
- Sep 2026
- First submitted
- 28 May 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Fang CY, Cora-Cruz M, Koirala P, Perez S, Li M, Egleston BL, Chen Y, Mantia-Smaldone G, Martinez O. Juntas Contra el Virus del Papiloma Humano: protocol for a pilot randomized controlled trial of an HPV self-sampling intervention for underscreened Latinas. Pilot Feasibility Stud. 2025 May 10;11(1):65. doi: 10.1186/s40814-025-01648-y.
PubMed 40349085
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Acceptability of Juntas Contra el Virus Del Papiloma Humano, an HPV Self-sampling Intervention for Underscreened Latinas
- ClinicalTrials.gov ID
- NCT06439706
- Acronym / sponsor ID
- 23-1027
- Conditions
- Uterine Cervical Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 Jun 2024 (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 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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mailed Kit Only Control | Active comparator | Behavioral: HPV Self-SamplingParticipants 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. |
| Education Plus Mailed Kit | Experimental | Behavioral: HPV Self-Sampling, Behavioral: Group EducationParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| HPV Self-SamplingHPV self-sampling kit | Behavioural | Education Plus Mailed Kit, Mailed Kit Only Control |
| Group EducationSmall-group education led by bilingual health educator | Behavioural | Education Plus Mailed Kit |
Primary outcome
Intervention Feasibility
Time frame: 1 month
The number of participants in the intervention arm who attend at least one session
1 secondary outcome
Participation in screening
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 40349085Fang CY, Cora-Cruz M, Koirala P, Perez S, Li M, Egleston BL, Chen Y, Mantia-Smaldone G, Martinez O. Juntas Contra el Virus del Papiloma Humano: protocol for a pilot randomized controlled trial of an HPV self-sampling intervention for underscreened Latinas. Pilot Feasibility Stud. 2025 May 10;11(1):65. doi: 10.1186/s40814-025-01648-y.
- Individual participant dataSharing planned: No. 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.
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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. This study is not recruiting at the moment.
Carolyn Fang, PhD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Self-Sampling and Group Education in people with Uterine Cervical Neoplasm, run by Fox Chase Cancer Center 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 3 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06439706, which also lists 1 linked publication.
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 3 Sep 2026.