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）：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，丙型肝炎病毒感染率较高。拟议的研究是一项随机对照试验，旨在改善 HIV/HCV 共同感染的吸毒者及其社交网络成员的健康结果并减少危险行为。实验条件是基于小组和二元的干预措施，培训艾滋病毒/丙型肝炎病毒合并感染的吸毒者的沟通和依从技能，并招募他们的社交网络进行艾滋病毒/丙型肝炎病毒检测，促进艾滋病毒医疗护理依从性，促进丙型肝炎病毒治疗和降低艾滋病毒/丙型肝炎病毒风险。该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。注射吸毒者将接受培训，使用移动技术，特别是短信，以促进其社交网络成员进行检测并降低风险。该干预措施成本低廉，易于融入各种医疗保健环境。 我们建议招募 300 名 HIV/HCV 合并感染吸毒者，他们在过去两年内曾中断过 HIV 护理。一半将被随机分配到实验条件，一半分配到同等关注控制。实验性干预将包括 8 次专注于遵守技能和同伴教育的小组会议、与网络成员的 2 次双人会议、为期 6 个月的每月强化课程以及为期 6 个月的移动健康行为提示。这些指数参与者将接受为期 24 个月的跟踪（3、6、12、18 和 24 个月的评估），包括使用个性化短信进行每两周一次的评估（通过短信评估对医疗预约的遵守情况并提示遵守 HIV 药物治疗的技能）。控制指数也将被跟踪 24 个月。指数参与者将与约翰霍普金斯大学 HCV 合并感染诊所联系起来，以评估肝功能和 HCV 慢性病。为了评估 HIV 药物治疗依从性，我们将使用调查、血浆 ARV 检测、CD4 计数、病毒载量以及通过短信发送的未公布的药物计数。符合医疗标准的人将接受丙肝病毒治疗。此外，还将招募 450 名 HCV 阳性网络成员，进行 HIV 和 HCV 检测，并进行纵向跟踪，以检查 HCV/HIV 治疗采用、依从性和风险降低的社会扩散情况。

 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.