Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588257
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men A Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Acceptability of the Human Papillomavirus HPV Vaccine and Anal HPV in Transgender Women TGW and Men Who Have Sex With Men MSM A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPVac
Brief Summary:
Protocol Title Acceptability of the Human Papillomavirus HPV Vaccine and Anal HPV in Transgender Women TGW and Men Who Have Sex with Men MSM A Pilot Study
Detailed Description:
Protocol Number FH-79
Study Objetives
Evaluate the acceptability uptake and completion of HPV vaccination
Determine the baseline prevalence before HPV vaccination and incidence of vaccine-specific genotypes of nonavalent HPV in the anus anatomical site after vaccination
Determine the initial prevalence before HPV vaccination and incidence of anal cytological lesions after HPV vaccination-
Determine the initial prevalence before HPV vaccination and incidence of oral and anogenital lesions associated with HPV according to physical examination after HPV vaccination
Analyze barriers and facilitators to the acceptability uptake and completion of HPV vaccination from the perspective of MSM and TGW
Patient Population MSM men who have sex with men and TGW transgender woman
Study design Phase IV Longitudinal and prospective study for which a cohort of 100 MSM men who have sex with menand TGW transgender woman will be formed at Fundación Huésped Pilot study of mixed quantitative and qualitative methodology
Regimens Non-infectious adjuvanted recombinant nonavalent HPV vaccine Three doses 0 2 6 months Trade name GARDASIL 9 -MSD Duration 12 months
Sample size 105 subjects
Study Objetives
Evaluate the acceptability uptake and completion of HPV vaccination
Determine the baseline prevalence before HPV vaccination and incidence of vaccine-specific genotypes of nonavalent HPV in the anus anatomical site after vaccination
Determine the initial prevalence before HPV vaccination and incidence of anal cytological lesions after HPV vaccination-
Determine the initial prevalence before HPV vaccination and incidence of oral and anogenital lesions associated with HPV according to physical examination after HPV vaccination
Analyze barriers and facilitators to the acceptability uptake and completion of HPV vaccination from the perspective of MSM and TGW
Patient Population MSM men who have sex with men and TGW transgender woman
Study design Phase IV Longitudinal and prospective study for which a cohort of 100 MSM men who have sex with menand TGW transgender woman will be formed at Fundación Huésped Pilot study of mixed quantitative and qualitative methodology
Regimens Non-infectious adjuvanted recombinant nonavalent HPV vaccine Three doses 0 2 6 months Trade name GARDASIL 9 -MSD Duration 12 months
Sample size 105 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None