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

March 1, 2023 updated by: Cristina Agusti, Fundació Institut Germans Trias i Pujol

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

218

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants will have 4 face-to-face quarterly follow up visits per year
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention to PrEP follow up
Time Frame: Two years follow-up (from baseline to year 2)
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
Time Frame: Two years follow-up (from baseline to year 2)
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
Time Frame: Two years follow-up (from baseline to year 2)
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
Time Frame: Two years follow-up (from baseline to year 2)
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
Time Frame: Two years follow-up (from baseline to year 2)
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
Time Frame: Two years follow-up (from baseline to year 2)
Aherence to PrEP in each arm
Two years follow-up (from baseline to year 2)
Samples sent to lab and results consulted
Time Frame: Two years follow-up (from baseline to year 2)
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
Time Frame: Two years follow-up (from baseline to year 2)
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
Time Frame: Two years follow-up (from baseline to year 2)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

Hospital Vall d'Hebron
Department of Health, Generalitat de Catalunya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2023

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEEISCATTESTATEPrEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only researchers in the study will be able to access this IPD. No data transfer will be made to third parties

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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