HPV Self-sampling for Underscreened Latinas

Uterine Cervical Neoplasm Clinical Trial

Official title:

Assessing the Feasibility and Acceptability of Juntas Contra el Virus Del Papiloma Humano, an HPV Self-sampling Intervention for Underscreened Latinas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439706
• Other study ID #: 23-1027
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Fox Chase Cancer Center
• Contact: Carolyn Fang, PhD
• Phone: 2157284062
• Email: carolyn.fang[@]fccc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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?

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.

Description:

We 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• HPV Self-Sampling
HPV self-sampling kit
• Group Education
Small-group education led by bilingual health educator

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	Pennsylvania Breast Cancer Coalition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	The number of participants who attend at least one session in the intervention arm	1 month
Secondary	Participation in screening	The number of participants who return a self-collected sample	1 month