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

Study Overview
=================
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.

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

Conditions
-----------------
HIV, STI

Intervention / Treatment
-----------------
* Other: Online follow up


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-blinded randomized controlled non-inferiority trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will have 4 face-to-face quarterly follow up visits per year | |
| Experimental: Experimental<br>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 | Other: Online follow up<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention to PrEP follow up | 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 (%) | Two years follow-up (from baseline to year 2) | 
| Healthcare burden | Median number of visits per participant and year at the PrEP Service | Two years follow-up (from baseline to year 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants diagnosed with HIV | Proportion of participants diagnosed with HIV in each arm | Two years follow-up (from baseline to year 2) | 
| Proportion of participants diagnosed with CT, NG and TP | Proportion of participants diagnosed with CT, NG and TP infections in each arm | Two years follow-up (from baseline to year 2) | 
| Proportion of participants who are prescribed treatment for HIV/STI | Proportion of participants who are prescribed treatment for HIV/STI in each arm | Two years follow-up (from baseline to year 2) | 
| Aherence to PrEP | Aherence to PrEP in each arm | Two years follow-up (from baseline to year 2) | 
| Samples sent to lab and results consulted | Number of participants of the experimental arm who send the samples to the laboratory, and consult the results | Two years follow-up (from baseline to year 2) | 
| Participants acceptability | The proportion of participants in the intervention group who agree that the online follow up combined with the face-to-face follow up at the PrEP service is acceptable | Two years follow-up (from baseline to year 2) | 
| Health professionals acceptability | The proportion of health care professionals of the PrEP service who agree that the online follow up combined with the face-to-face follow up at the PrEP service is acceptable | Two years follow-up (from baseline to year 2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, STI, Pre-exposure prophylaxis (PrEP), e-STI, Self-sampling, Screening, ICT