NCT05752643

Feasibility and Impact of Online HIV/STI Screening Addressed to PrEP Users in Spain

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Fundació Institut Germans Trias i Pujol · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HIV
• STI

Interventions

Type	Name	Description
OTHER	Online follow up	The online follow up will include screening for HIV and STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP)) based in a self-sampling strategy

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-09-30
• Completion: 2025-12-31
• First posted: 2023-03-02
• Last updated: 2023-03-02