Feasibility and Impact of Online HIV/STI Screening Addressed to Men Who Have Sex With Men and Transgender Women Pre-exposure Prophylaxis (PrEP) Users in Spain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 218
- 主要终点
- Healthcare burden
研究概览
简要总结
Non-blinded randomized controlled non-inferiority trial to evaluate the feasibility, acceptability and impact of an innovative internet-accessed HIV and STIs screening intervention (TÉSTATE PrEP) addressed to gays, bisexuals and other men who have sex with men (GBMSM) and transgender women users of PrEP in Spain as part of PrEP follow up.
详细描述
The objectives of the study are 1) To design and implement an e-HIV/STI testing pilot intervention (TÉSTATE PrEP) to offer self-sampling kits to detect HIV, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP) among gays, bisexuals and other men who have sex with men (GBMSM) and transgender women users of pre-exposure prophylaxis (PrEP) as part of PrEP follow up. 2) To evaluate if the pilot does not cause a reduction of the retention to PrEP follow up among the target population. 3) To analyze the capacity of the intervention to reduce the healthcare burden of the PrEP service. 4) To evaluate the acceptability of the intervention among PrEP users and healthcare workers of the PrEP services; and 5) To validate dried blood samples (DBS) for confirmation of TP infection and performing RPR to determine stage and activity of infection comparing with blood drawn by venous puncture. Investigators will perform a non-blinded randomized controlled non-inferiority trial among PrEP users on follow up in one of the main PrEP services of Spain. Participants on the control arm will follow the usual follow up protocol with quarterly face-to-face visits where they will be tested for HIV and STIs. Participants in the experimental arm will alternate face-to-face meetings with online screening of HIV and STIs. This project is based on the TÉSTATE project (PI17 00355). The website https://testate.org/ will include a module for online follow-up visits of participants on PrEP. Participants of the experimental arm will register in the website and will receive self-sampling kits to their home to get tested for HIV, CT, NG and TP. Participants will send the samples to the reference laboratory and check their results online. The investigators will compare the retention to follow up among PrEP users in the control and experimental arm and the healthcare burden in each group. The acceptability of the intervention among the PrEP users and healthcare workers will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
盲法说明
Due to the nature of the intervention, participants will know to which arm they have been allocated. So, it would not be possible to blind either the participants or healthcare professionals
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •GBMSM or transgender women
- •PrEP users with more than 1 year of follow up in the collaborating center (The Centre for International Health and Infectious Diseases Drassanes Vall d'Hebron (Barcelona))
- •Not having altered renal function
- •Resident in Spain
排除标准
- •Not able to read in Spanish
- •Not able to give their consent
研究组 & 干预措施
Control
Participants will have 4 face-to-face quarterly follow up visits per year
Experimental
Participants will alternate face-to-face visits with online screening every three months. They will have two face-to-face and two online screenings per year
干预措施: Online follow up (Other)
结局指标
主要结局
Healthcare burden
时间窗: Two years follow-up (from baseline to year 2)
Median number of visits per participant and year at the PrEP Service
Retention to PrEP follow up
时间窗: Two years follow-up (from baseline to year 2)
Proportion of PrEP users that who have not missed any follow-up visit: Number of participants who have not missed a follow up visit /total number of participants in follow up for PrEPx100 (%)
次要结局
- Samples sent to lab and results consulted(Two years follow-up (from baseline to year 2))
- Proportion of participants diagnosed with HIV(Two years follow-up (from baseline to year 2))
- Proportion of participants who are prescribed treatment for HIV/STI(Two years follow-up (from baseline to year 2))
- Aherence to PrEP(Two years follow-up (from baseline to year 2))
- Proportion of participants diagnosed with CT, NG and TP(Two years follow-up (from baseline to year 2))
- Participants acceptability(Two years follow-up (from baseline to year 2))
- Health professionals acceptability(Two years follow-up (from baseline to year 2))
研究者
Cristina Agusti
Principal Investigator
Fundació Institut Germans Trias i Pujol