A RCT of HIV Adherence Case Management and Modified DOT

抗逆转录病毒疗法（ART）大大降低了艾滋病毒造成的死亡率。药物依从性差是成功治疗的主要障碍。高比例的精神疾病、物质使用和不稳定的住房使得城市穷人的坚持特别成问题。我们建议进行一项三臂随机对照研究，研究旨在提高城市贫困人口对ART的依从性的两种干预措施：1）依从性病例管理（ACM）和2）改良直接观察治疗（MDOT）。336名无家可归和居住在边缘的艾滋病毒感染者接受每日一次或每日两次抗逆转录病毒联合治疗， 可检测的病毒载量和430%的药丸计数依从性将被随机分配到每种状况（每种状况112个）。ACM干预将作为由旧金山公共卫生部弗朗西斯科资助的持续坚持支持计划的一部分提供。MDOT计划将在我们目前位于旧金山弗朗西斯科Tenderloin区的店面研究地点进行。艾滋病毒抗逆转录病毒治疗的依从性将通过未公布的药丸计数和CAS 1患者音频访谈方法来衡量。我们将研究这两种干预措施对四个特定领域的影响：1）坚持抗逆转录病毒治疗，2）HIV- 1病毒载量的变化，3）病毒耐药性的发展，以及4）干预措施的成本效益。在6个月的干预期间和干预后6个月期间，将每季度评估一次结果，以检查干预效果的持久性。

Antiretroviral therapy (ART) dramatically reduces mortality due to HIV. Poor adherence to medication is a major barrier to successful treatment. High rates of mental illness, substance use, and unstable housing make adherence particularly problematic in the urban poor. We propose to carry out a three arm, randomized controlled study of two interventions aimed at improving adherence to ART in the urban poor: 1) Adherence Case Management (ACM) and 2) Modified Directly Observed Therapy (MDOT). 336 homeless and marginally housed HIV individuals on either once-daily or twice-daily combination antiretroviral therapy with detectable viral loads and 430% pill count adherence will be randomized to each condition (1 12 per condition). The ACM intervention will be delivered as part of an ongoing adherence support program funded by the San Francisco Department of Public Health. The MDOT program will be operated at our current storefront research site in the Tenderloin District of San Francisco. Adherence to HIV antiretroviral therapy will be measured by unannounced pill count and an audio-CAS1 patient interview method. We will investigate the impact of these two interventions on four specific areas: 1) adherence to antiretroviral therapy, 2) changes in HIV- 1 viral load, 3) development of viral resistance, and 4) cost effectiveness of the interventions. Outcomes will be assessed quarterly during the 6-month intervention and during a 6 month post-intervention period to examine the durability of the intervention effect.