Development of an HIV Medication Adherence Intervention Via Videophones

描述（由申请人提供）：拟议研究的目的是开发和试点测试认知干预，空间检索（SPARE），嵌入依从性咨询计划，HAART CARE（HC），并通过视频电话提供抗逆转录病毒治疗（ART）依从性的影响。依从性结果将通过一种创新的方法-通过可视电话进行的未宣布的药丸计数（UPC）进行监测。HC + SPARE将在农村或城市地区的HIV感染者中与仅HC的情况进行比较，有或没有认知障碍。在形成阶段，将招募40名自我报告ART依从性低于75%的18岁或以上的受试者，其中一半（n=20）生活在城市地区（Greater Cleveland，OH），一半（n=20）生活在农村地区（靠近Athens，OH）;每个研究中心的一半将符合认知障碍标准，另一半将不符合标准。这些受试者将通过视频电话单独接受8次仅HC治疗。将在基线、干预后1周、1个月和3个月评估ART依从性（UPC-通过视频电话和自我报告）和健康结局（HIV生活质量、病毒载量和CD 4计数）。对于20%的UPC视频电话评估，将在参与者家中同时进行现场UPC。这一阶段的目标是确定：1）城市和农村环境中艾滋病毒感染者接受可视电话的程度; 2）使用可视电话的障碍; 3）如何收集遵守措施（UPC和自我报告）; 4）如何通过可视电话提供HC; 5）如何初步评估通过可视电话提供的依从性干预产生的效果;以及6）通过可视电话进行的UPC与亲自进行的UPC相比如何。接下来，在手动化阶段，将改进仅HC和HC +备件的可视电话传送。本阶段的目标是制定可视电话的手册程序：7）进行UPC; 8）仅提供HC; 9）提供HC + SPARE。最后，在随机对照试验（RCT）阶段，将招募80名年龄在18岁或以上，自我报告ART依从性低于75%的人。同样，一半（n=40）将来自城市站点，一半（n=40）来自农村站点;每个站点的一半将符合认知障碍的标准，另一半则不符合。在每个研究中心，一半的受试者将被随机分配接受仅HC和一半HC + SPARE。将在基线、干预后1周、1个月和3个月测量依从性和健康结局。本阶段的目标是确定：10）通过可视电话实施仅提供HC和HC + SPARE的手动程序的效果如何; 11）作为通过可视电话提供的依从性干预，HC + SPARE干预与仅提供HC相比的有效性; 12）认知障碍水平与干预效果之间的关系; 13）农村与城市环境的影响。这项研究将解决ART依从性中一个关键但被忽视的因素，认知障碍;进一步开发一种干预措施来弥补它;并使用创新技术，视频电话，来提供干预措施并测量其对依从性的影响。

DESCRIPTION (provided by applicant): The purpose of the proposed study is to develop and pilot-test effects of a cognitive intervention, Space Retrieval (SPARE), embedded within an adherence counseling program, HAART CARE (HC), and delivered via videophone, on antiretroviral therapy (ART) adherence. Adherence outcomes will be monitored by an innovative method-unannounced pill counts (UPCs) conducted via videophone. HC + SPARE will be compared with a HC only condition in persons living with HIV in either a rural or urban area, and with or without cognitive impairment. In the formative stage, 40 persons, age 18 years or older, who self-report less than 75% ART adherence will be recruited, with half (n=20) living in an urban area (Greater Cleveland, OH), and half (n=20) in a rural area (near Athens, OH); half at each site will meet criteria for cognitive impairment and half will not. These participants will be provided eight HC only treatment sessions individually via videophone. ART adherence (UPC-via videophone and self-report) and health outcomes (HIV quality of life, viral load and CD4 count) will be assessed at baseline, and at 1-week, 1-month and 3-months post-intervention. For 20% of all UPC-videophone assessments, a concurrent in-person UPC will be conducted at the participant's home. Objectives of this stage are to determine: 1) How well videophones are accepted by persons with HIV in urban and rural settings; 2) Barriers to utilization of videophones; 3) How to collect adherence measures (UPCs and self-reports) via videophones; 4) How to deliver HC via videophone; 5) How to initially assess effects produced by an adherence intervention delivered via videophone; and 6) How UPCs conducted via videophone compare with UPCs conducted in-person. Next, in a manualization stage, videophone delivery of both HC only and HC + SPARE will be refined. Objectives of this stage are to develop manualized procedures for videophone: 7) Conducting UPCs; 8) Delivering HC only; and 9) Delivering HC + SPARE. Finally, in a randomized control trial (RCT) stage, 80 persons, age 18 years or older, who self-report less than 75% ART adherence will be recruited. Again, half (n=40) will come from the urban site, and half (n=40) from the rural site; half at each site will meet criteria for cognitive impairment and half will not. At each site, half of the participants will be randomly assigned to receive HC only and half HC + SPARE. Adherence and health outcomes will be measured at baseline, 1-week, 1-month and 3-months post-intervention. Objectives of this stage are to determine: 10) How well manualized procedures for delivering HC only and HC + SPARE can be implemented via videophone; 11) The effectiveness of the HC + SPARE intervention compared to HC only as an adherence intervention delivered via videophone; 12) The relationship between level of cognitive impairment and the interventions' effects; and 13) The influence of Rural vs. Urban environments. This study will address a critical yet neglected factor in ART adherence, cognitive impairment; further develop an intervention to compensate for it; and use innovative technology, videophones, to both deliver the intervention and measure its effect on adherence.