Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439706
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
HPV Self-sampling for Underscreened Latinas
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Assessing the Feasibility and Acceptability of Juntas Contra el Virus Del Papiloma Humano an HPV Self-sampling Intervention for Underscreened Latinas
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn if women of HispanicLatina 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 HispanicLatina 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
Does a brief educational intervention increase the feasibility and acceptability of HPV self-sampling among HispanicLatina 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 n100 who will be randomly assigned to either the educational intervention n50 or a control condition n50 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None