Incentives for Suppression of HIV-1 RNA in People Living with HIV

 描述（由申请人提供）：成年HIV感染者持续使用抗逆转录病毒药物可以将血浆HIV-1 RNA（病毒载量）抑制到无法检测的水平，从而提高存活率和生活质量，并减少HIV相关感染、医疗保健费用和HIV传播。尽管抗逆转录病毒疗法有潜在的好处，但感染艾滋病毒的成年人并没有可靠地接受艾滋病毒护理或持续接受抗逆转录病毒药物治疗。很少有干预措施能有效地增加依从性并将病毒载量抑制到无法检测的水平，并且没有治疗产生在干预停止后持续的长期影响。当患者达到所需的治疗目标时，为患者提供激励的干预措施已被证明在促进不同人群的治疗行为改变方面非常有效，并且在促进抗逆转录病毒药物的依从性和抑制病毒载量方面显示出前景。然而，只有有限的评价这些干预措施，以促进坚持抗逆转录病毒药物和抑制病毒载量，这些评价没有采用最佳参数的激励干预措施，他们没有产生的病毒载量抑制水平，临床需要。我们建议评估一种新的激励干预措施，以促进抑制艾滋病毒感染者的病毒载量，该措施将采用已被证明对激励干预措施的有效性至关重要的基于药物的参数。来自巴尔的摩两个为成年HIV感染者提供服务的医疗诊所的参与者（N = 200）将被随机分配到激励组或家庭护理对照组。激励组参与者将获得维持抑制和不可检测的病毒载量的激励。该激励计划将采用高强度激励措施，在患者病毒载量达到无法检测的水平之前，在治疗早期提供降低病毒载量的激励措施，在治疗早期安排频繁的激励措施，并随着参与者逐渐达到更长的病毒载量抑制期而减少激励措施的频率，为持续抑制病毒载量安排逐步升级的激励措施，干预将持续两年。艾滋病护理控制参与者将只接受其诊所提供的标准艾滋病毒医疗护理。在2年治疗期间每3个月进行一次评估，在治疗后一年中每6个月进行一次评估。主要结局指标将是在整个2年干预期间进行的3个月评估中病毒载量检测不到的受试者百分比。次要措施将包括坚持艾滋病毒护理和治疗后的结果。我们亦会评估有关诱因对抑制病毒载量的影响的调节者和中介者，并进行成本效益和成本效益分析。如果激励性干预措施能够维持抑制的病毒载量，并且经济合理，则可用于改善艾滋病毒感染者的健康状况，降低医疗保健成本，并减少社区中的艾滋病毒传播。

 DESCRIPTION (provided by applicant): Consistent use of antiretroviral medications by adults living with HIV can suppress plasma HIV-1 RNA (viral load) to undetectable levels and thereby improve survival rates and quality of life, and reduce HIV-related infections, health care costs, and transmission of HIV. Despite the potential benefits of antiretroviral therapy, adults living wih HIV have not been reliably engaged in HIV care or sustained on antiretroviral medications. Few interventions have been shown effective in increasing adherence and suppressing viral loads to undetectable levels, and no treatments have produced long-term effects that sustain after the intervention is discontinued. Interventions that provide incentives to patients when they meet required therapeutic goals have been demonstrated extraordinarily effective in promoting therapeutic behavior change in diverse populations and they have shown promise in promoting adherence to antiretroviral medications and suppression of viral loads. However, only limited evaluations of these interventions have been conducted to promote adherence to antiretroviral medications and suppress viral loads, those evaluations have not employed optimal parameters of incentive interventions, and they have not produced levels of viral load suppression that are needed clinically. We propose to evaluate a novel incentive intervention to promote suppression of viral load in people living with HIV that will employ empirically-based parameters that have been proven critical to the effectiveness of incentive interventions. Participants (N = 200) from two medical clinics that serve adults living with HIV in Baltimore will be randomly assigned to an Incentive or a Usual Care Control group. Incentive group participants will receive incentives for maintaining suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient s viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years. Usual Care Control participants will only receive the standard HIV medical care offered in their clinic. Assessments will be conducted every 3 months throughout the two years of treatment and every 6 months throughout the year following treatment. The primary outcome measure will be the percentage of participants that have undetectable viral loads at the 3-month assessments conducted throughout the 2-year intervention period. Secondary measures will include adherence to HIV care and post- treatment outcomes. We will also assess moderators and mediators of the effects of the incentives on the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If the incentive intervention maintains suppressed viral load and is economically sound, it could be used to improve the health of adults living with HIV, reduce health care costs, and reduce HIV transmission in the community.