|- candidate number||24029|
|- NTR Number||NTR5741|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-feb-2016|
|- Secondary IDs||METC 2014_407 Appendix 2|
|- Public Title||How to promote PrEP adherence? A trial for participants of the Amsterdam PrEP project|
|- Scientific Title||A nested randomised controlled trial of the effect of adherence interventions: the AMPrEP App plus.|
|- hypothesis||To assess whether individualized feedback of self-reported PrEP medication adherence increases subsequent PrEP use, as measured by tenofovir levels in dried blood spots, in participants using daily PrEP.
|- Healt Condition(s) or Problem(s) studied||Compliance|
|- Inclusion criteria||All of the following:|
• Participant of the daily PrEP group within AMPrEP and prefers to continue daily PrEP use
• Has installed and used the regular AMPrEP App on smart phone or tablet
• Willing and able to comply to RCT procedures
• Willing and able to give written informed consent
|- Exclusion criteria||None|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-mrt-2016|
|- planned closingdate||1-jun-2018|
|- Target number of participants||150|
|- Interventions||Intervention: the AMPrEP App PLUS|
The intervention to improve adherence that will be tested in this RCT consists of individualized feedback provided in an AMPrEP App PLUS, based on the adherence date that the participant himself has provided. The feedback will consist of four parts. The first part involves automated personal messages. The participant will receive a message when: (1) he has not completed the information that he is asked to complete in the application for 3 days in a row or (2) he indicated that he did not take his pill for 3 days in a row. Moreover, he will receive an automated personal message when (3) he indicated that he took the medication for 7 days in a row, followed by (4) messages every time after indicating he took the medication for 30 days in a row.
Secondly, a new tab with graphic visualization of adherence and trends in adherence will be added to the App. In this tab, participants can see trend in their adherence behavior per week or month. Thirdly, a bar chart that indicates the proportion of days with PrEP use per month will be included.
The final part of the App is a private tab for taking daily notes. This part is added to facilitate the use of the App. The researchers will have no access to the information of this part of the App.
This intervention is developed with input from the community engagement group and the participant group of the demonstration project.
|- Primary outcome||good adherence at 12 and 24 months. Good adherence is measured by tenofovir levels in dried blood spot. Good adherence is defined as a level of ≥700 fmol/punch, which corresponds to a use of four or more tablets per week of tenofovir/emtricitabine 29.|
|- Secondary outcome||1. To assess the use of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group)|
2. To compare acceptability and usability of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group)
3. To compare self-reported adherence from questionnaires, from the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) and from pill-counts in both groups
4. To evaluate risk compensation in both study groups
5. To determine the rate of HIV seroconversion in both groups
6. To determine the perceived level of HIV protection in both groups
7. To determine the level of adherence self-efficacy in both groups
8. To evaluate perceived adherence support of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group)
9. To assess whether demographic variables, drug use, sexual risk behaviour, STI prevalence, perceived HIV risk and beliefs on PrEP efficacy are independent predictors of adherence, as measured by tenofovir levels in dried blood spots
|- Timepoints||March 2016 until August 2016: Recruitment of participants
August 2016 until June 2018: follow-up and data collection
Beginning of 2017: Interim analyses
June 2018: End of the study
June 2018 until December 2018: Data analyses
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||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 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.
|- Main changes (audit trail)|
|- RECORD||25-feb-2016 - 22-mei-2016|