Status:
ACTIVE_NOT_RECRUITING
Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study
Lead Sponsor:
Fundación Huésped
Collaborating Sponsors:
MSD Pharmaceuticals LLC
Conditions:
HPV
Eligibility:
MALE
18-90 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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:
- 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
- CD4 cell count ≥ 200 cells/ml in the last 6 months (participant can bring a laboratory report from the last 6 months)
Exclusion
- 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\'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.
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2026
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06588257
Start Date
October 9 2024
End Date
April 9 2026
Last Update
June 13 2025
Active Locations (1)
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1
Fundación Huésped
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1427CEA