HPV Self-sampling for Underscreened Latinas

Last updated: October 11, 2024
Sponsor: Fox Chase Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Cervical Cancer

Uterine Disorders

Treatment

Group Education

HPV Self-Sampling

Clinical Study ID

NCT06439706
23-1027
  • Ages 30-65
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Self-reported Hispanic/Latina ethnicity

  • Assigned female sex at birth

  • Age 30-65, consistent with guidelines for HPV DNA testing for cervical cancerscreening

  • 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 thepast 3 years; no hrHPV testing either alone or in combination with cytology in thepast 5 years).

Exclusion

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 apregnancy

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: Group Education
Phase:
Study Start date:
October 04, 2023
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

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