Clinical trial NCT05752643: Feasibility and Impact of Online HIV/STI Screening Addressed to PrEP Users in Spain
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
STI
Keywords: HIV
STI
Pre-exposure prophylaxis (PrEP)
e-STI
Self-sampling
Screening
ICT
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
name: Hospital Vall d'Hebron
First posted: 2023-03-02
Enrollment: 218
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-blinded randomized controlled non-inferiority trial
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention to PrEP follow up
timeFrame: Two years follow-up (from baseline to year 2)
measure: Healthcare burden
timeFrame: Two years follow-up (from baseline to year 2)
Secondary outcomes:
measure: Proportion of participants diagnosed with HIV
timeFrame: Two years follow-up (from baseline to year 2)
measure: Proportion of participants diagnosed with CT, NG and TP
timeFrame: Two years follow-up (from baseline to year 2)
measure: Proportion of participants who are prescribed treatment for HIV/STI
timeFrame: Two years follow-up (from baseline to year 2)
measure: Aherence to PrEP
timeFrame: Two years follow-up (from baseline to year 2)
measure: Samples sent to lab and results consulted
timeFrame: Two years follow-up (from baseline to year 2)
measure: Participants acceptability
timeFrame: Two years follow-up (from baseline to year 2)
measure: Health professionals acceptability
timeFrame: Two years follow-up (from baseline to year 2)
Other outcomes:
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