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

NCT ID: NCT06588257

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2026-04-09

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

Conditions

HPV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Men who have sex with men with HIV

Evaluate the acceptability, uptake, and completion of HPV vaccination.

Group Type: OTHER

Non-infectious adjuvanted recombinant nonavalent HPV vaccine

Intervention Type: BIOLOGICAL

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

Transgender women with HIV

Evaluate the acceptability, uptake, and completion of HPV vaccination.

Group Type: OTHER

Non-infectious adjuvanted recombinant nonavalent HPV vaccine

Intervention Type: BIOLOGICAL

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

Men who have sex with men without HIV

Evaluate the acceptability, uptake, and completion of HPV vaccination.

Group Type: OTHER

Non-infectious adjuvanted recombinant nonavalent HPV vaccine

Intervention Type: BIOLOGICAL

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

Transgender women without HIV

Evaluate the acceptability, uptake, and completion of HPV vaccination.

Group Type: OTHER

Non-infectious adjuvanted recombinant nonavalent HPV vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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).

Intervention Type: BIOLOGICAL

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'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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

MSD Pharmaceuticals LLC

INDUSTRY

Sponsor Role: collaborator

Fundación Huésped

OTHER

Sponsor Role: lead

Responsible Party

FLORENCIA MARINA CAHN

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fundación Huésped

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Countries

Argentina

Other Identifiers

FH-79

Identifier Type: -

Identifier Source: org_study_id