RCT of a social-network oriented mhealth based intervention to increase access and adherence to HCV treatment and HIV viral suppression

 描述（由申请人提供）：在注射毒品（PWID）的人群中，艾滋病毒医疗护理和病毒抑制的连续性水平较低，HCV感染率较高。这项研究是一项随机对照试验，旨在改善HIV/HCV合并感染的PWID及其社交网络成员的健康结果并减少风险行为。实验条件是一个小团体和基于双干预培训艾滋病毒/丙型肝炎病毒共感染的PWID的沟通和遵守技能，并招募他们的社交网络的艾滋病毒/丙型肝炎病毒检测和促进艾滋病毒的医疗护理依从性，促进丙型肝炎病毒治疗，艾滋病毒/丙型肝炎病毒的风险降低。干预措施将采用移动健康方法来提示行为并解决依从性障碍。PWID将接受培训，使用移动的技术，特别是短信，以促进测试和降低风险，以其社会网络成员。该干预措施的设计成本低，易于整合到各种医疗保健环境中。 我们建议招募300名HIV/HCV合并感染的PWID，他们在过去两年内中断了HIV护理。一半被随机分配到实验条件下，另一半被分配到同等注意力控制下。实验性干预将包括8个小组会议，重点是坚持技能和同伴教育，2个与网络成员的二元会议，每月助推器会议6个月，和mhealth行为提示6个月。这些指数参与者将被随访24个月（3、6、12、18和24个月评估），包括使用个性化短信（短信，以评估遵守医疗预约和提示遵守艾滋病毒药物治疗的技能）每两周进行一次评估。对照指数也将随访24个月。指数参与者将与约翰霍普金斯HCV合并感染诊所联系，以评估肝功能和HCV慢性化。为了评估HIV药物治疗的依从性，我们将使用调查、血浆ARV检测、CD4计数、病毒载量和通过短信进行的未宣布的药丸计数。符合医疗标准的人将接受HCV治疗。此外，还将招募450名HCV阳性网络成员，进行HIV和HCV检测，并进行纵向随访，以检查HCV/HIV治疗吸收、依从性和风险降低的社会传播。

 DESCRIPTION (provided by applicant): There are low levels of continuity of HIV medical care and viral suppression and high rates of HCV among people who inject drugs (PWID). The proposed study is an RCT to improve health outcomes and reduce risk behaviors among HIV/HCV co-infected PWID and their social network members. The experimental condition is a small-group and dyadic based intervention to train HIV/HCV co-infected PWID in communication and adherence skills and to recruit their social networks for HIV/HCV testing and promote HIV medical care adherence, facilitate HCV treatment, and HIV/HCV risk reduction. The intervention will employ a mhealth approach to cue behaviors and address barriers to adherence. PWID will be trained to use mobile technology, specifically SMS, to promote testing and risk reduction to their social network members. The intervention is designed to be low cost, easily integrated into a variety of medical care settings. We propose recruiting 300 HIV/HCV co-infected PWID who have had an interruption in HIV care within the prior two years. Half will be randomly assigned to the experimental condition and half to the equal attention control. The experimental intervention will include 8 group sessions that focus on adherence skills and peer education, 2 dyad sessions with network members, monthly booster sessions for 6 months, and mhealth cuing of behavior for 6 months. These Index participants will be followed for 24 months (3, 6, 12, 18, & 24 month assessments) including biweekly assessments using personalized SMS (text messages to assess adherence to medical appointments and to cue skills for adhering to HIV medications). Control Indexes will also be followed for 24 months. Index participants will be linked to the Johns Hopkins HCV co-infection clinic to assess liver function and HCV chronicity. To assess HIV medication adherence, we will use surveys, plasma ARV assays, CD4 counts, viral load, and unannounced pill counts via SMS. Those meeting medical criteria will be offered HCV treatment. Additionally, 450 HCV positive network members will be recruited, tested for HIV and HCV, and followed longitudinally to examine the social diffusion of HCV/HIV treatment uptake, adherence, and risk reduction.