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)：在注射吸毒者(PWID)中，艾滋病毒医疗护理和病毒抑制的连续性水平较低，而丙型肝炎病毒感染率较高。这项拟议的研究是一项旨在改善艾滋病毒/丙型肝炎合并感染的PWID及其社会网络成员的健康结果和减少危险行为的随机对照试验。实验条件是以小组和二元为基础的干预措施，培训艾滋病毒/丙型肝炎合并感染的PWID患者的沟通和依附技能，招募他们的社会网络进行艾滋病毒/丙型肝炎检测，促进艾滋病毒医疗的依从性，促进丙型肝炎病毒治疗，降低艾滋病毒/丙型肝炎病毒风险。干预将使用mHealth方法来提示行为并解决遵守的障碍。PWID将接受培训，使用移动技术，特别是短信，向其社交网络成员推广测试和降低风险。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名艾滋病毒/丙型肝炎病毒联合感染的PWID患者，他们在过去两年内曾中断艾滋病毒治疗。一半被随机分配给实验条件，另一半被分配给同等注意力控制。实验干预将包括8个专注于坚持技能和同伴教育的小组会议，2个与网络成员的二元会议，6个月的每月助推器会议，以及6个月的mHealth行为提示。这些指数参与者将被跟踪24个月(3个月、6个月、12个月、18个月和24个月的评估)，包括使用个性化短信(用于评估对医疗预约的遵守情况和提示遵守艾滋病毒药物的技能的短信)的双周评估。控制指标也将被跟踪24个月。指数参与者将被连接到约翰·霍普金斯大学的丙型肝炎病毒联合感染诊所，以评估肝功能和丙型肝炎病毒的慢性化。为了评估HIV的服药依从性，我们将使用调查、血浆ARV分析、CD4计数、病毒载量和通过短信的未宣布的药片计数。那些符合医学标准的人将接受丙型肝炎病毒治疗。此外，还将招募450名丙型肝炎病毒阳性网络成员，进行艾滋病毒和丙型肝炎病毒检测，并进行纵向跟踪，以检查丙型肝炎病毒/艾滋病治疗方案的社会扩散情况、依从性和风险降低情况。

 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.