Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT06588257
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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06588257
Study Brief:
Protocol Section:
NCT06588257