Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study (HPVac)
May 13, 2026 updated by: FLORENCIA MARINA CAHN, Fundación Huésped
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 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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Buenos Aires
-
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1427CEA
- Fundación Huésped
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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:
- 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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Men who have sex with men with HIV
Evaluate the acceptability, uptake, and completion of HPV vaccination.
|
Non-infectious adjuvanted recombinant nonavalent HPV vaccine.
Three doses (0, 2, 6 months).
(Trade name GARDASIL 9 -MSD).
|
|
Other: Transgender women with HIV
Evaluate the acceptability, uptake, and completion of HPV vaccination.
|
Non-infectious adjuvanted recombinant nonavalent HPV vaccine.
Three doses (0, 2, 6 months).
(Trade name GARDASIL 9 -MSD).
|
|
Other: Men who have sex with men without HIV
Evaluate the acceptability, uptake, and completion of HPV vaccination.
|
Non-infectious adjuvanted recombinant nonavalent HPV vaccine.
Three doses (0, 2, 6 months).
(Trade name GARDASIL 9 -MSD).
|
|
Other: Transgender women without HIV
Evaluate the acceptability, uptake, and completion of HPV vaccination.
|
Non-infectious adjuvanted recombinant nonavalent HPV vaccine.
Three doses (0, 2, 6 months).
(Trade name GARDASIL 9 -MSD).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited.
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of anal HPV genotypes
Time Frame: 12 months
|
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.
|
12 months
|
|
Frequency of anal HPV related cytologic lesions
Time Frame: 12 months
|
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.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of HPV vaccine
Time Frame: 12 months
|
Through in-depth interviews will evaluate barriers and facilitators, as well as prospective and retrospective acceptability of HPV vaccine.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2024
Primary Completion (Actual)
May 4, 2026
Study Completion (Actual)
May 4, 2026
Study Registration Dates
First Submitted
August 29, 2024
First Submitted That Met QC Criteria
September 6, 2024
First Posted (Actual)
September 19, 2024
Study Record Updates
Last Update Posted (Actual)
May 15, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FH-79
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It will be shared upon request, 6 months after last patient´s last visit.
URL not yet available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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