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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Men who have sex with men with HIV
Evaluate the acceptability, uptake, and completion of HPV vaccination.
干预措施: Non-infectious adjuvanted recombinant nonavalent HPV vaccine (Biological)
Transgender women with HIV
Evaluate the acceptability, uptake, and completion of HPV vaccination.
干预措施: Non-infectious adjuvanted recombinant nonavalent HPV vaccine (Biological)
Men who have sex with men without HIV
Evaluate the acceptability, uptake, and completion of HPV vaccination.
干预措施: Non-infectious adjuvanted recombinant nonavalent HPV vaccine (Biological)
Transgender women without HIV
Evaluate the acceptability, uptake, and completion of HPV vaccination.
干预措施: Non-infectious adjuvanted recombinant nonavalent HPV vaccine (Biological)
结局指标
主要结局
Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited.
时间窗: 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.
次要结局
- Frequency of anal HPV genotypes(12 months)
- Frequency of anal HPV related cytologic lesions(12 months)
研究者
FLORENCIA MARINA CAHN
MD
Fundación Huésped