Evaluating the HPV vaccine's acceptability in transgender women and men who have sex with men
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
This study is testing how well transgender women and men who have sex with men accept and complete the HPV vaccine to understand their experiences and any challenges they face.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Fundación Huésped Academic / other |
| Locations | 1 site (Ciudad Autónoma de Buenos Aires, Buenos Aires) |
| Trial ID | NCT06588257 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the acceptability, uptake, and completion of the HPV vaccine among transgender women and men who have sex with men. It will evaluate the baseline prevalence and incidence of vaccine-specific HPV genotypes and anal cytological lesions before and after vaccination. The study will utilize a mixed-methods approach, combining quantitative and qualitative data from a cohort of 100 participants over a 12-month period. Participants will receive three doses of the nonavalent HPV vaccine, GARDASIL 9, and their experiences and barriers to vaccination will be analyzed.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and older who identify as men who have sex with men or transgender women.
Not a fit: Patients with a history of cancer or high-grade lesions related to HPV may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve HPV vaccination rates and health outcomes in transgender women and men who have sex with men.
How similar studies have performed: While there have been studies on HPV vaccination in general populations, this specific focus on transgender women and men who have sex with men is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ciudad Autónoma de Buenos Aires, Buenos Aires
- Fundación Huésped — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (Recruiting)
Study contacts
- Study coordinator: Florencia M Cahn, MD
- Email: florencia.cahn@huesped.org.ar
- Phone: 1121209999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.