Uterine Cervical Neoplasm
Conditions
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.
Interventions
BEHAVIORALHPV Self-Sampling
HPV self-sampling kit
BEHAVIORALGroup Education
Small-group education led by bilingual health educator
Sponsors
Pennsylvania Breast Cancer Coalition
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility | 1 month | The number of participants in the intervention arm who attend at least one session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participation in screening | 1 month | The number of participants who return a self-collected sample |
Countries
United States
Outcome results
None listed