HIV, STI
Conditions
Keywords
HIV, STI, Pre-exposure prophylaxis (PrEP), e-STI, Self-sampling, Screening, ICT
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.
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.
Interventions
OTHEROnline 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
Sponsors
Department of Health, Generalitat de Catalunya
Hospital Vall d'Hebron
Fundació Institut Germans Trias i Pujol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
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
Intervention model description
Non-blinded randomized controlled non-inferiority trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention to PrEP follow up | 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 | Two years follow-up (from baseline to year 2) | Median number of visits per participant and year at the PrEP Service |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who are prescribed treatment for HIV/STI | Two years follow-up (from baseline to year 2) | Proportion of participants who are prescribed treatment for HIV/STI in each arm |
| Aherence to PrEP | Two years follow-up (from baseline to year 2) | Aherence to PrEP in each arm |
| Proportion of participants diagnosed with HIV | Two years follow-up (from baseline to year 2) | Proportion of participants diagnosed with HIV in each arm |
| Participants acceptability | 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 |
| Health professionals acceptability | 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 |
| Samples sent to lab and results consulted | 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 |
| Proportion of participants diagnosed with CT, NG and TP | Two years follow-up (from baseline to year 2) | Proportion of participants diagnosed with CT, NG and TP infections in each arm |
Outcome results
None listed