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Clinical Trial NCT06588257 (HPVac) for HPV is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study (HPVac) Phase 4 101 Vaccine Study
Clinical Trial NCT06588257 (HPVac) is designed to study Prevention for HPV. It is a Phase 4 interventional study that is active, not recruiting, having started on 9 October 2024, with plans to enroll 101 participants. Led by Fundación Huésped, it is expected to complete by 9 April 2026. The latest data from ClinicalTrials.gov was last updated on 13 June 2025.
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.-
- Deter...
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
Conditions
HPVOther Study IDs
- HPVac
- FH-79
NCT ID Number
Start Date (Actual)
2024-10-09
Last Update Posted
2025-06-13
Completion Date (Estimated)
2026-04-09
Enrollment (Estimated)
101
Study Type
Interventional
PHASE
Phase 4
Status
Active, not recruiting
Keywords
HPV
MSM
TGW
Acceptability
vaccine
MSM
TGW
Acceptability
vaccine
Primary Purpose
Prevention
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherMen who have sex with men with HIV Evaluate the acceptability, uptake, and completion of HPV vaccination. | 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). |
OtherTransgender women with HIV Evaluate the acceptability, uptake, and completion of HPV vaccination. | 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). |
OtherMen who have sex with men without HIV Evaluate the acceptability, uptake, and completion of HPV vaccination. | 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). |
OtherTransgender women without HIV Evaluate the acceptability, uptake, and completion of HPV vaccination. | 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). |
Primary Outcome Measures
Secondary 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. | 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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Frequency of anal HPV genotypes | 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 | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
Accepts Healthy Volunteers
Yes
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)
- 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.
Fundación HuéspedMSD Pharmaceuticals LLCStudy Responsible Party
FLORENCIA MARINA CAHN, Principal Investigator, MD, Fundación Huésped
No contact data.
1 Study Locations in 1 Countries
Buenos Aires
Fundación Huésped, Ciudad Autónoma de Buenos Aires, Buenos Aires, C1427CEA, Argentina