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Real-time monitoring and just-in-time intervention for adherence to pre-exposure prophylaxis among men who have sex with men in China: a multicentre RCT study protocol.
- Source :
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BMC Public Health . 7/24/2020, Vol. 20 Issue 1, p1-7. 7p. 1 Color Photograph, 2 Diagrams, 3 Charts. - Publication Year :
- 2020
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Abstract
- <bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>This study registered at ClinicalTrials.gov ( ChiCTR1900025604 ) on September 2, 2019. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PRE-exposure prophylaxis
*MEN who have sex with men
*HIV infection transmission
*INTERNET of things
*CLINICAL trials
*FOLLOW-up studies (Medicine)
*HIV prevention
*ANTI-HIV agents
*HEALTH care reminder systems
*SELF-evaluation
*PREVENTIVE health services
*HOMOSEXUALITY
*RANDOMIZED controlled trials
*DRUGS
*COMPUTER systems
*RESEARCH funding
*PATIENT compliance
*TEXT messages
*EARLY medical intervention
Subjects
Details
- Language :
- English
- ISSN :
- 14712458
- Volume :
- 20
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- BMC Public Health
- Publication Type :
- Academic Journal
- Accession number :
- 144744706
- Full Text :
- https://doi.org/10.1186/s12889-020-08709-2