HPV Self-sampling for Underscreened Latinas

Temple University Health System (TUHS)

Status: Completed

Conditions: Uterine Cervical Neoplasm

Treatments: Behavioral: HPV Self-Sampling; Behavioral: Group Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06439706

23-1027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Mailed Kit Only Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: HPV Self-Sampling

Education Plus Mailed Kit

Experimental group

Description:

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.

Treatment:

Behavioral: Group Education

Behavioral: HPV Self-Sampling