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

描述（由申请方提供）：我们建议开发和评估一种基于计算机的干预措施，该措施使用手机，以增强秘鲁成人艾滋病毒阳性患者对抗逆转录病毒治疗（ART）的依从性，并支持降低艾滋病毒传播风险。坚持抗逆转录病毒疗法对于在个人层面上成功治疗和避免出现耐药艾滋病毒株至关重要。在秘鲁，虽然最近开始采用抗逆转录病毒疗法，但坚持艾滋病毒治疗的问题尚未得到适当解决。需要采取创新办法，利用手机等信息技术，提高艾滋病毒/艾滋病患者对抗逆转录病毒疗法的坚持率。该研究的具体目标是：1）进行形成性研究，以评估将纳入基于计算机的系统中的特定文化行为信息; 2）开发和测试一个使用手机的交互式基于计算机的系统，以提高抗逆转录病毒疗法的依从性，并提供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疗法依从性和性风险行为的影响。为了实现这些目标，我们将进行一项为期12个月的干预随机对照试验，比较[1]标准护理（n=50）与[2]标准护理加手机系统（n=50）在Via Libre接受ART的患者中，这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18岁以上的成年人，他们目前正在接受ART治疗并给予同意。这些患者将在一年的研究期间招募，并将被随机分配接受基于手机的系统或标准护理。两组之间的结果将通过每月调查（通过电话或互联网）进行监测，以确定干预对ART依从性和性风险行为的影响。自我报告的药物依从性和对诊所预约的依从性;以及自我报告的HIV传播风险行为将是关注的主要终点;还将评估对HIV-1病毒载量和CD 4计数的影响。干预组将收到：1）通过他们的手机量身定制的提醒，采取他们的ART和参加预定的艾滋病毒诊所预约;和2）通过他们的手机量身定制的艾滋病毒传播风险降低信息。这项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必要性和方向，以评估对资源匮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.