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| Name | Class |
|---|---|
| Department of Health, Generalitat de Catalunya | OTHER_GOV |
| Hospital Vall d'Hebron | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online follow up | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants diagnosed with HIV | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender Men who are gay, bisexual and other men who have sex with men (GBMSM) ; and Transgender women
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37844988 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Non-blinded randomized controlled non-inferiority trial
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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
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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 | 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 | Aherence to PrEP in each arm | 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 | 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 | 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 | Two years follow-up (from baseline to year 2) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |