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中试认知干预，太空检索(SPARE)，嵌入依从性咨询计划，HAART CARE(HC)，并通过视频电话提供，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的方法进行监测--通过视频电话进行未宣布的药片计数(UPC)。无论是在农村还是城市地区，有或没有认知障碍的艾滋病毒携带者，HC+SPARE将与仅HC条件下的患者进行比较。在形成阶段，将招募40名18岁或以上、自我报告艺术坚持程度低于75%的人，其中一半(n=20)生活在城市地区(俄亥俄州大克利夫兰)，另一半(n=20)生活在农村地区(靠近雅典，俄亥俄州)；每个地点各有一半符合认知障碍标准，另一半不符合标准。这些参与者将通过视频电话单独接受八次仅限HC的治疗。将在基线以及干预后1周、1个月和3个月评估抗逆转录病毒治疗的依从性(通过视频电话和自我报告)和健康结果(艾滋病毒生活质量、病毒载量和CD4计数)。对于所有UPC-视频电话评估的20%，将在参与者的家中同时进行面对面UPC。这一阶段的目标是确定：1)城市和农村艾滋病毒携带者接受视频电话的程度如何；2)使用视频电话的障碍；3)如何通过视频电话收集遵守措施(普遍承诺和自我报告)；4)如何通过视频电话提供合规；5)如何初步评估通过可视电话提供的坚持干预所产生的影响；以及6)通过视频电话进行的普遍承诺与亲自进行的普遍承诺如何比较。下一步，在手册阶段，将改进仅HC和HC+备件的视频电话交付。这一阶段的目标是制定视频电话的手册程序：7)进行UPC；8)仅交付HC；以及9)交付HC+备件。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、自我报告的ART依从性低于75%的人。同样，一半(n=40)人将来自城市地点，一半(n=40)人来自农村地点；每个地点的一半将符合认知障碍的标准，另一半不符合。在每个地点，一半的参与者将被随机分配为仅接受HC和一半HC+Spare的参与者。依从性和健康结果将在干预后的基线、1周、1个月和3个月进行评估。这一阶段的目标是确定：10)通过视频电话实施仅提供HC和HC+START的机械化程序的效果如何；11)与仅通过视频电话提供的坚持干预相比，HC+SPART干预的有效性；12)认知损害程度与干预效果之间的关系；以及13)农村环境与城市环境的影响。这项研究将解决ART坚持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--来提供干预并衡量其对坚持的影响。

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.