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OpenTrials
Completed

NCT Number: NCT06439706

HPV Self-sampling 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.

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV self-sampling

Behavioral

HPV self-sampling kit

Group Education

Behavioral

Small-group education led by bilingual health educator

Primary outcomes

  1. Intervention Feasibility

    Time frame: 1 month

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

Secondary outcomes

  1. Participation in screening

    Time frame: 1 month

    The number of participants who return a self-collected sample

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • Pennsylvania Breast Cancer Coalition

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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