HPV Self-sampling for Underscreened Latinas

NCT06439706 | Completed

• 1 other identifier: 23-1027
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasm

Outcome Measures

Primary Outcomes (1)

• Intervention Feasibility

  The number of participants in the intervention arm who attend at least one session

  1 month

Secondary Outcomes (1)

• Participation in screening

  1 month

Study Arms (2)

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.

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.

Behavioral: HPV Self-Sampling; Behavioral: Group Education

Interventions

HPV Self-Sampling BEHAVIORAL

HPV self-sampling kit

Education Plus Mailed Kit; Mailed Kit Only Control

Group Education BEHAVIORAL

Small-group education led by bilingual health educator

Education Plus Mailed Kit

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Pennsylvania Breast Cancer Coalition: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• 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.

  PMID: 40349085 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Carolyn Fang, PhD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Population Science

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: October 4, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)