HPV Self-sampling for Underscreened Latinas
- Conditions
- Uterine Cervical Neoplasm
- Interventions
- Behavioral: HPV Self-SamplingBehavioral: Group Education
- Registration Number
- NCT06439706
- Lead Sponsor
- Fox Chase Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 108
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mailed Kit Only Control HPV Self-Sampling 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. Education Plus Mailed Kit HPV Self-Sampling 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. Education Plus Mailed Kit Group Education 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.
- Primary Outcome Measures
Name Time Method Intervention Feasibility 1 month The number of participants in the intervention arm who attend at least one session
- Secondary Outcome Measures
Name Time Method Participation in screening 1 month The number of participants who return a self-collected sample
Trial Locations
- Locations (1)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States