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

Fundació Institut Germans Trias i Pujol

Status: Not yet enrolling

Conditions: STI; HIV

Treatments: Other: Online follow up

Study type: Interventional

Funder types: Other

Identifiers

NCT05752643

CEEISCATTESTATEPrEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ≥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

Exclusion criteria

• Not able to read in Spanish
• Not able to give their consent

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Control

No Intervention group

Description:

Participants will have 4 face-to-face quarterly follow up visits per year

Experimental

Experimental group

Description:

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

Treatment:

Other: Online follow up