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护理（HC），并通过视频电话传递，对抗逆转录病毒治疗（ART）依从性的影响。依从性结果将通过一种创新方法-通过视频电话进行的未公布药丸计数（upc）来监测。HC + SPARE将与农村或城市地区的艾滋病毒感染者（有或没有认知障碍）仅HC状况进行比较。在形成阶段，将招募40名年龄在18岁或以上，自我报告抗逆转录病毒治疗依从性低于75%的人，其中一半（n=20）生活在城市地区（大克利夫兰，俄亥俄州），一半（n=20）生活在农村地区（雅典附近，俄亥俄州）；每个地点一半的人符合认知障碍的标准，另一半则不符合。这些参与者将通过视频电话单独接受8次HC治疗。ART依从性（upc -通过视频电话和自我报告）和健康结果（HIV生活质量、病毒载量和CD4计数）将在基线、干预后1周、1个月和3个月进行评估。对于所有UPC视频电话评估的20%，将在参与者家中进行同时进行的亲自UPC。本阶段的目标是确定：1)城市和农村环境中艾滋病毒感染者对可视电话的接受程度；2)视频电话使用障碍；3)如何通过视频电话收集遵守措施（upc和自我报告）；4)如何通过视频电话传递HC；5)如何初步评估通过视频电话提供的依从性干预所产生的效果；以及6)通过可视电话进行的UPCs与面对面进行的UPCs的比较。接下来，在手动化阶段，将细化HC + SPARE和HC + SPARE的可视电话交付。本阶段的目标是开发可视电话的手动程序：7)进行UPCs；8)只提供HC；9) HC + SPARE的交付。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、自我报告抗逆转录病毒治疗依从性低于75%的患者。同样，一半（n=40）将来自城市场地，一半（n=40）来自农村场地；每个地点一半的人符合认知障碍的标准，另一半则不符合。在每个站点，一半的参与者将被随机分配为只接受HC和一半HC + SPARE。依从性和健康结果将在干预后的基线、1周、1个月和3个月进行测量。这一阶段的目标是确定：10)如何通过视频电话实现仅提供HC和HC + SPARE的手动程序；11)与仅通过视频电话进行依从性干预的HC + SPARE干预相比，HC干预的有效性；12)认知障碍水平与干预效果的关系；13)农村与城市环境的影响。这项研究将解决抗逆转录病毒治疗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补偿它；并且使用创新的技术，视频电话，来提供干预并衡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.