Looptijd: 1 oktober 2015 - 20 april 2019
AmPrep ZonMw
We will perform a randomised controlled trial (RCT), nested in the AMPrEP project. The study will not be blinded.
Recruitment and enrolment
Recruitment and enrolment will take place at the 3- or 6-month visit of daily PrEP users. A week before or at the scheduled visit, participants will be informed about the adherence RCT and be invited to participate. They will receive the participant information. During the visit, there will be ample time to answer questions about the adherence RCT. If the daily PrEP user agrees to join the adherence RCT, written informed consent will be obtained.
Participants are randomized to the intervention arm with access to the AMPrEP App PLUS, or the control arm with no intervention (with access to the “standard” AMPrEP App). A baseline self-administered questionnaire will be completed.
Randomisation
Randomisation is performed by using a computer randomisation program, in a ratio 1:1 to the intervention group and the control group, at the 3-month or 6-month visit.
Follow-up and assessments
Follow-up visits will take place according to the schedule of the AMPrEP project. During the visits, there will be no extra study procedures apart from a short questionnaire at 5 time-points (paragraph 6 of this appendix).
At the 3-month (or, if not possible at 3-month time point, at 6-month), the 6-month, the 9-month and the 12-month visit and the 24-month visit, a blood sample is taken for tenofovir levels in dried blood spots (see page 32 of the AMPrEP protocol version 5.9).
A subset of participants (20-30) will be invited for a structured interview with a researcher about use, acceptability and usability of the application.
(Projectnummer 522002003)
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