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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain

NCT06860945

Sexually Transmitted Infections (STIs) HIV PrEP

RECRUITING

Testing a Gender-inclusive HIV Prevention Program

NCT06586151

HIV Prevention

RECRUITING NA

Demonstration Project on the Feasibility to Implement PrEP in MSM and TG Women

NCT03043326

HIV Prevention

UNKNOWN

EASY-TESTS: Evaluation of the Acceptability of Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex With Men (MSM) Who Accepted Targeted HIV/STI Testing, Recruited Through a Community-based Outreach Approach, Both Digital and In-person.

NCT05949814

HIV Infections STI

COMPLETED

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project

NCT04077151

HIV/AIDS Gender Behavior and Behavior Mechanisms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV STI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-blinded randomized controlled non-inferiority trial

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Online follow up

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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