NCT06588257

Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study

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: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Fundación Huésped · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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 men)and 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

Conditions

• HPV

Interventions

Type	Name	Description
BIOLOGICAL	Non-infectious adjuvanted recombinant nonavalent HPV vaccine	Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD).

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-04-09
• Completion: 2026-04-09
• First posted: 2024-09-19
• Last updated: 2025-06-13

Locations

1 site across 1 country: Argentina