Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9,000
- 试验地点
- 26
- 主要终点
- STI predictive model
研究概览
简要总结
Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.
Methods: Ambispective cohort study, multicentric (23 Spanish hospitals). All PrEP users, with follow-up within the program, will be included. Entry into the program will be considered as the baseline visit. From there, patients are followed quarterly, following the national protocols for monitoring PrEP users in Spain. At each visit, diagnosis of different STIs (serum, pharyngeal swab, urethral or urine sample, rectal swab, endocervical/vaginal swab, ulcer) is performed. Primary outcome variable: development of an STI (Yes/No). The following STIs will be considered: syphilis, Neisseria gonorrhoeae (NG) infection, Chlamydia trachomatis (CT) infection, lymphogranuloma venereum (LGV), Mycoplasma genitalium (MG) infection, genital herpes, hepatitis A, hepatitis B, hepatitis C, HIV infection, and MPOX. Secondary outcome variable: number of diagnosed STIs. In order to determine factors associated with acquiring an STI, multivariate analyses will be conducted using logistic regression. The best models will be analyzed in the validation population. To compare the models, we will follow the Bayesian approach suggested by Benavoli et al.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All individuals with documented initiation of oral PrEP (daily or event-driven regimens), who have collected the medication at least once and have taken at least one pill, will be included in the study.
- •The approved criteria for the use of oral PrEP in Spain, as recommended by the Spanish Gesida guidelines (GeSIDA. Recomendaciones sobre la Profilaxis Pre-Exposición para la Prevención de la Infección por VIH en España. Marzo
- •Available at http://.gesida-seimc.org/category/guias-clinicas/otras-guias-vigentes/), are as follows:
- •People without HIV infection at the time of cohort inclusion
- •Age ≥ 16 yr who meet the following criteria:
- •MSM and transgender women with at least two of the following criteria during the last year: > 10 sexual partners; Condomless anal sex; Chemsex; PEP; ≥ 1 STI
- •Sex worker women who report non-habitual use of condoms.
- •Cisgender males/females, who report condomless and present at least two of the same criteria as MSM and transgender.
- •PWID with unsafe injection practices
排除标准
- 未提供
结局指标
主要结局
STI predictive model
时间窗: through study completion, an average of 5 years
Predictive model for the acquisition of sexually transmitted infections in individuals using PrEP within the national provision program for this strategy
次要结局
- PrEP discontinuation(through study completion, an average of 5 years)
- HIV incident infection(through study completion, an average of 5 years)
- Time to discontinuation(through study completion, an average of 5 years)
- STI incidence(through study completion, an average of 5 years)
- asymptomatic STIs(through study completion, an average of 5 years)
- behavioral changes(through study completion, an average of 5 years)
- STI dynamics(through study completion, an average of 5 years)
- DOXYPEP(through study completion, an average of 5 years)
- Predictor of PrEP discontinuation(through study completion, an average of 5 years)
- PrEP adherence(through study completion, an average of 5 years)
研究者
Anais Corma-Gomez
Medical Doctor, PhD
Hospital Clínico Universitario de Valencia