NCT05752643

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
218

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable hiv

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

February 20, 2023

Last Update Submit

March 1, 2023

Conditions

HIVSTI

Keywords

HIVSTIPre-exposure prophylaxis (PrEP)e-STISelf-samplingScreeningICT

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Proportion of participants diagnosed with HIV

    Two years follow-up (from baseline to year 2)

  • Proportion of participants diagnosed with CT, NG and TP

    Two years follow-up (from baseline to year 2)

  • Proportion of participants who are prescribed treatment for HIV/STI

    Two years follow-up (from baseline to year 2)

  • Aherence to PrEP

    Two years follow-up (from baseline to year 2)

  • Samples sent to lab and results consulted

    Two years follow-up (from baseline to year 2)

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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

Interventions

Online follow upOTHER

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

Experimental

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender Men who are gay, bisexual and other men who have sex with men (GBMSM) ; and Transgender women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Agusti C, Martinez Riveros H, Garcia-Perez J, Descalzo V, Fernandez G, Ramirez-Marinero A, Gonzalez MV, Diaz Y, Montoro-Fernandez M, Romano-deGea P, Araujo SG, Muntada E, Casabona J. Feasibility and impact of online HIV/STI screening addressed to men who have sex with men and transgender women users of pre-exposure prophylaxis (PrEP) in Spain (TESTATE PrEP): a study protocol for a non-blinded randomised controlled trial. BMJ Open. 2023 Oct 16;13(10):e073459. doi: 10.1136/bmjopen-2023-073459.

    PMID: 37844988DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Non-blinded randomized controlled non-inferiority trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

March 15, 2023

Primary Completion

September 30, 2024

Study Completion

December 31, 2025

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

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