HIV Clinical Trial
— TESTATE_PrEPOfficial 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
Verified date | March 2023 |
Source | Fundació Institut Germans Trias i Pujol |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 218 |
Est. completion date | December 31, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut Germans Trias i Pujol | Department of Health, Generalitat de Catalunya, Hospital Vall d'Hebron |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | Healthcare burden | Median number of visits per participant and year at the PrEP Service | Two years follow-up (from baseline to year 2) | |
Secondary | Proportion of participants diagnosed with HIV | Proportion of participants diagnosed with HIV in each arm | Two years follow-up (from baseline to year 2) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Aherence to PrEP | Aherence to PrEP in each arm | Two years follow-up (from baseline to year 2) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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