HIVTESTATE_PrEPNCT05752643
Feasibility and Impact of Online HIV/STI Screening Addressed to PrEP Users in Spain
A study testing Online follow up in people with HIV and STI, run by Fundació Institut Germans Trias i Pujol.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- Online follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- Not able to read in Spanish
- Not able to give their consent
About this study
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
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.
Read the 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.
- Being tested
- Online follow up
- Keywords
- HIV, STI, Pre-exposure prophylaxis (PrEP), e-STI, Self-sampling, Screening, ICT
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Online follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: Two years follow-up (from baseline to year 2)
Healthcare burden
Median number of visits per participant and year at the PrEP Service
Measured: Two years follow-up (from baseline to year 2)
Secondary outcomes (7)
Proportion of participants diagnosed with HIV
Proportion of participants diagnosed with HIV in each arm
Measured: 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
Measured: 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
Measured: Two years follow-up (from baseline to year 2)
Aherence to PrEP
Aherence to PrEP in each arm
Measured: 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
Measured: 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
Measured: 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
Measured: Two years follow-up (from baseline to year 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start15 Mar 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded randomized controlled non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya, Hospital Vall d'Hebron
- Responsible party
- Principal investigator, Cristina Agusti, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752643
- Sponsor's protocol ID
- CEEISCATTESTATEPrEP
- Acronym
- TESTATE_PrEP
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only researchers in the study will be able to access this IPD. No data transfer will be made to third parties
Publications
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.
PubMed 37844988
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05752643
- Acronym / sponsor ID
- TESTATE_PrEP / CEEISCATTESTATEPrEP
- Keywords
- HIV, STI, Pre-exposure prophylaxis (PrEP), e-STI, Self-sampling, Screening, ICT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya, Hospital Vall d'Hebron
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded randomized controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will have 4 face-to-face quarterly follow up visits per year |
| Experimental | Experimental | Other: Online follow upParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (2 listed)
- Not able to read in Spanish
- Not able to give their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online follow upThe 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 | Other | Experimental |
Primary outcome
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 (%)
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
7 secondary outcomes
Proportion of participants diagnosed with HIV
Time frame: 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 who are prescribed treatment for HIV/STI
Time frame: Two years follow-up (from baseline to year 2)
Aherence to PrEP
Time frame: 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)
Participants acceptability
Time frame: Two years follow-up (from baseline to year 2)
Health professionals acceptability
Time frame: Two years follow-up (from baseline to year 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Derived from this study: PubMed 37844988Agusti 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.
- Individual participant dataSharing planned: No. Only researchers in the study will be able to access this IPD. No data transfer will be made to third parties
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Online follow up in people with HIV and STI, run by Fundació Institut Germans Trias i Pujol.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention to PrEP follow up (time frame: Two years follow-up (from baseline to year 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.