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

NCT06588257 | Active Not Recruiting Phase 4

• 1 other identifier: FH-79
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV

Keywords

HPV; MSM; TGW; Acceptability; vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Frequency of anal HPV genotypes

  12 months

• Frequency of anal HPV related cytologic lesions

  12 months

Other Outcomes (1)

• Acceptability of HPV vaccine

  12 months

Study Arms (4)

Men who have sex with men with HIV

OTHER

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

Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine

Transgender women with HIV

OTHER

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

Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine

Men who have sex with men without HIV

OTHER

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

Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine

Transgender women without HIV

OTHER

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

Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine

Interventions

Non-infectious adjuvanted recombinant nonavalent HPV vaccine 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 with HIV; Men who have sex with men without HIV; Transgender women with HIV; Transgender women without HIV

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Huésped: lead
• MSD Pharmaceuticals LLC: collaborator

Study Sites (1)

Fundación Huésped

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1427CEA, Argentina

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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).

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: October 9, 2024
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

AR (1)