Evaluation of a Computer-Based System using Cell Phones for HIV people in Peru

描述（由申请人提供）：我们建议在秘鲁开发和评估一种使用手机的基于计算机的干预措施，以提高抗逆转录病毒治疗（ART）的依从性，并支持艾滋病毒阳性成人患者降低艾滋病毒传播风险。坚持抗逆转录病毒治疗对于在个人层面成功治疗和避免出现耐药艾滋病毒株至关重要。秘鲁最近引进了抗逆转录病毒治疗，但坚持艾滋病毒治疗的问题尚未得到妥善解决。需要使用诸如手机等信息技术的创新方法来提高艾滋病毒/艾滋病患者对抗逆转录病毒药物的依从性。本研究的具体目的是：1)进行形成性研究，以评估将包含在基于计算机的系统中的文化特定行为信息；2)开发和测试一种使用手机的交互式计算机系统，以加强抗逆转录病毒治疗的依从性，并传递减少艾滋病毒传播风险的信息；3)评估该系统对抗逆转录病毒依从性和性危险行为的影响。为了实现这些目标，我们将进行一项为期12个月的干预的随机对照试验，在Via Libre接受抗逆转录病毒治疗的患者中比较[1]标准治疗（n=50）和bb0标准治疗加基于手机的系统（n=50）。Via Libre是一个为帮助艾滋病毒感染者而成立的非政府组织。我们将招募100名目前正在接受抗逆转录病毒治疗的18岁以上成年人并给予同意。这些患者将在为期一年的研究期间被招募，并将被随机分配接受基于手机的系统或标准护理。将使用每月调查（通过电话或互联网）监测两组之间的结果，以确定干预对抗逆转录病毒治疗依从性和性危险行为的影响。自我报告的服药依从性和对门诊预约的依从性；自我报告的艾滋病毒传播风险行为将是主要的研究终点；还将评估对HIV-1病毒载量和CD4计数的影响。干预组将收到：1)通过手机定制的提醒，提醒他们服用抗逆转录病毒药物并参加预定的艾滋病毒诊所预约；2)通过手机定制减少艾滋病毒传播风险的信息。这项试点随机对照试验将确定对这种基于手机的系统进行更大规模评估的需求和方向，以评估对资源贫乏环境中艾滋病毒感染者的抗逆转录病毒治疗依从性和性行为的影响。

DESCRIPTION (provided by applicant): We propose to develop and evaluate a computer-based intervention using cell phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission risk-reduction among adult HIV- positive patients in Peru. Adherence to ART is critical for treatment success at the individual level and to avoid the onset of resistant strains of HIV. In Peru, where ART has recently been introduced, adherence to HIV treatment has not yet beenjaddressed properly. Innovative approaches using information technologies such as cell phones are needed to increase adherence to ART for people with HIV/AIDS. The specific aims of the study are to: 1) Conduct formative research to assess culturally-specific behavioral messages to be included in the computer-based system; 2) Develop and test an interactive computer-based system using cell phones to enhance adherence to ART and to deliver HIV transmission risk reduction messages; 3) Evaluate the impact of the system on antiretroviral adherence and sexual risk behaviors. To achieve these aims, we will conduct a randomized controlled trial of a 12-month intervention, comparing [1] standard-of- care (n=50) with [2] standard-of-care plus cell phone-based system (n=50) among patients receiving ART at Via Libre, a non-governmental organization established to help people with HIV. We will recruit 100 adults over 18 years old who are currently on ARTs and give consent. The patients will be recruited during a one- year study period and will be randomly assigned to receive either a cell phone-based system or the standard-of-care. Outcomes between the two groups will be monitored using monthly surveys (by phone or the Internet) to determine effects of the intervention on ART adherence and sexual risk behaviors. Self- reported medication adherence and adherence to clinic appointments; and self-reported HIV transmission risk behaviors will be the primary endpoints of interest; impact on HIV-1 viral load and CD4 count also will be assessed. The intervention group will receive: 1) Tailored reminders via their cell phones to take their ART and attend scheduled HIV clinic appointments; and 2) Tailored HIV transmission risk reduction messages via their cell phones. This pilot randomized-controlled trial will define the need and direction for larger evaluations of this cell phone-based system to assess impact on ART adherence and sexual behaviors of vulnerable populations living with HIV in resource-poor settings.