Clinical trial NCT06439706: HPV Self-sampling for Underscreened Latinas
Official title: Assessing the Feasibility and Acceptability of Juntas Contra el Virus Del Papiloma Humano, an HPV Self-sampling Intervention for Underscreened Latinas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasm
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: Pennsylvania Breast Cancer Coalition
First posted: 2024-06-03
Enrollment: 108
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention Feasibility
timeFrame: 1 month
Secondary outcomes:
measure: Participation in screening
timeFrame: 1 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Carolyn Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References: