Abstract:
BACKGROUND:Pre-exposure prophylaxis (PrEP) is an effective biomedical strategy to prevent transmission of HIV infection, although medication adherence remains a challenge. We present the protocol for a multicentre randomised controlled trial to measure the effectiveness of a real-time monitoring and just-in-time intervention on medication adherence among PrEP users in China. METHODS:Study participants will include 1000 men who have sex with men (MSM) from four cites in China (Shenyang, Beijing, Chongqing and Shenzhen) attending a tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) PrEP project as part of a real-world, prospective multicentre cohort study (CROPrEP). Participants will be randomised into the intervention and control arms in a 1:1 ratio. Participants in the intervention arm will be provided with remote real-time monitoring equipment that triggers twice just-in-time SMS (Short Messaging Service) medication reminders to PrEP users every half an hour when a scheduled dosage is missed, and followed with just-in-time SMS medication reminders to clinicians half an hour when there is no supplement after the second just-in-time SMS reminder to PrEP users. Clinicians will initiate individualised telephone intervention as soon as possible upon receipt of the just-in-time SMS missed dose alert. Those in the control arm will only receive generic weekly SMS reminders. The study will last 6 months. Participants will be seen at follow-up visits at three and 6 months. Trial outcomes to be measured include self-reported adherence assessed via questionnaire and pill counts, as well as drug concentration test results. DISCUSSION:Medication adherence is critical to achieve optimal benefits from PrEP. This study will be the first individualised behaviour intervention using real-time technology to increase adherence among MSM PrEP users globally. If found effective, a real-time monitoring and just-in-time intervention system may be utilized for improving adherence and thus effectiveness of global PrEP application. TRIAL REGISTRATION:This study registered at ClinicalTrials.gov ( ChiCTR1900025604 ) on September 2, 2019.
journal_name
BMC Public Healthjournal_title
BMC public healthauthors
Jin X,Wang H,Li H,Chu Z,Zhang J,Hu Q,Lv W,Huang X,Chen Y,Wang H,He X,Zhang L,Hu Z,Bao R,Li S,Ding H,Geng W,Jiang Y,Shang H,Xu J,CROPrEP Study Team.doi
10.1186/s12889-020-08709-2subject
Has Abstractpub_date
2020-07-24 00:00:00pages
1160issue
1issn
1471-2458pii
10.1186/s12889-020-08709-2journal_volume
20pub_type
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