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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
101
Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD).
Fundación Huésped
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited.
To evaluate uptake HPV vaccination, the proportion of who receiving the first dose of HPV vaccine among those who have entered the study will be estimated, and to assess HPV vaccination completion, the proportion of who receiving three doses of HPV vaccine among those enrolled will be estimated.
Time frame: 12 months
Frequency of anal HPV genotypes
To determine the prevalence and incidence of anal HPV genotypes (considering the genotypes in the nonavalent vaccine), HPV genotype from anal samples will be performed to determine the frequency of anal HPV at baseline (day 1), month 6 and month 12.
Time frame: 12 months
Frequency of anal HPV related cytologic lesions
To determine the prevalence and incidence of anal HPV-associated cytological lesions, anal cytology will be performed to determine the frequency of anal HPV associated cytological lesions at baseline (day 1), month 6 and month 12.
Time frame: 12 months
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