Clinical trial NCT06588257: Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HPV
Keywords: HPV
MSM
TGW
Acceptability
vaccine
Lead sponsor: Fundación Huésped
Sponsor class: OTHER
Collaborators: name: MSD Pharmaceuticals LLC
First posted: 2024-09-19
Enrollment: 101
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot study of mixed quantitative and qualitative methodology is proposed. A prospective cohort of 100 men who have sex with men and transgender women, with and without HIV will be organized at Fundación Huésped to study acceptability of HPV vaccine and effect of HPV vaccine on anal HPV infection. Moreover, 20 people from the cohort along with 5 additional people who shall not agree to receive the HPV vaccine will participate in in depth interviews. (qualitative component).
Primary purpose: PREVENTION

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 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

Eligibility criteria: Inclusion Criteria:

* Accept participation in the study by signing informed consent
* Age ≥18 years old
* People who consider themselves men who have sex with men or transgender women
* All eligible people with HIV must meet the following:

  1. stable antiretroviral treatment during the last 6 months and with undetectable viral load (depending on the method used for measurement) within the same period (the participant can bring a laboratory report carried out in the last 6 months). Regarding ART, a change associated with toxicity or simplification may be allowed before 12 weeks of the selection visit, with undetectable VL between 12 weeks and the selection visit; and
  2. CD4 cell count ≥ 200 cells/ml in the last 6 months (participant can bring a laboratory report from the last 6 months)

Exclusion Criteria:

* Have a history or current suspicion of cancer
* Have a known history or current suspicion of high-grade lesion or anal intraepithelial neoplasia related to HPV.
* Have received any dose of HPV vaccine at some time in your life.
* Have received any vaccine in the last 30 days.
* Have a known allergy to any of the components of the HPV vaccine.
* Have a history of a previous severe allergic reaction, regardless of the cause.
* Presenting an acute illness that could alter the study evaluations or could put the participant at risk, according to the researcher\&#39;s criteria.
* Present chronic or acute immunosuppression (except HIV).
* Have received antineoplastic and immunomodulatory agents or radiotherapy in the 6 months prior to the study or plan to receive these treatments during the study period.
* Having chronic diseases without adequate control.
* Have a diagnosis of ongoing malignant disease.
* Having received immunoglobulins, blood or blood products in the last 3 months.
* Do not participate in another intervention study
* That he is not an employee or first-degree relative of any member of the institution.
* Any condition or clinical situation where it is considered that participation in the study may pose a risk to the patient.\* \* People with chronic HBV infection, who are receiving treatment and have normal transaminases for the last 6 months can be included in the study. People with chronic HCV infection can enter the study if they have normal transaminases for the last 6 months and do not plan to start treatment during the study. In either case, transaminases can be requested through the study if they are not available.

Primary outcomes:
measure: Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited.
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of anal HPV genotypes
timeFrame: 12 months
measure: Frequency of anal HPV related cytologic lesions
timeFrame: 12 months
Other outcomes:
measure: Acceptability of HPV vaccine
timeFrame: 12 months
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Huésped
state: Buenos Aires
Study officials:
References: