Journal Article

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

Wang, Hongyi, Li, Hang, Chen, Yaokai, Wang, Hui, Geng, Wenqing, He, Xiaoqing, Lv, Wei, Hu, Zhili, Huang, Xiaojie, Zhang, Jing, Hu, Qinghai, Bao, Rantong, Jiang, Yongjun, Li, Shangcao, Ding, Haibo, Jin, Xia, Shang, Hong, Chu, Zhenxing, Zhang, Lukun, Xu, Junjie

2020

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Aged / Anti-HIV Agents - therapeutic use / Antiretroviral drugs / Assessment of Medication Adherence / Biostatistics / Care and treatment / Cellular telephones / China / Computer Systems / Disease prevention / Disease transmission / Dosage / Drug dosages / Drug monitoring / Drug resistance / Drugs / Early Medical Intervention - methods / Electronic drug monitors / Emtricitabine / Emtricitabine - therapeutic use / Environmental Health / Epidemiology / Evaluation / Gays & lesbians / Health behavior / health promotion and society / HIV / HIV infections / HIV Infections - prevention & control / HIV, men who have sex with men / Homosexuality, Male - psychology / Homosexuality, Male - statistics & numerical data / Hospitals / Human immunodeficiency virus / Humans / Internet of things / Intervention / Male / Medication adherence / Medicine / Medicine & Public Health / Mens health / Methods / Middle Aged / MSM (Men who have sex with men) / Multicenter Studies as Topic / Patient compliance / Patient outcomes / Pre-exposure prophylaxis / Pre-Exposure Prophylaxis - statistics & numerical data / Prophylaxis / Prospective Studies / Public Health / Randomization / Randomized Controlled Trials as Topic / Real time / Reminder Systems / Remote monitoring / Self Report / Sexually transmitted diseases / Short message service / STD / Study Protocol / Technology application / Tenofovir / Tenofovir - therapeutic use / Text Messaging / Vaccine / Young Adult