A RCT of HIV Adherence Case Management and Modified DOT

抗逆转录病毒疗法(ART)极大地降低了艾滋病毒的死亡率。服药依从性差是成功治疗的主要障碍。精神疾病、药物使用和住房不稳定的高比率使坚持治疗在城市贫困人口中尤其成问题。我们建议对两种旨在改善城市贫困人口对抗逆转录病毒治疗依从性的干预措施进行三组随机对照研究：1)依从性病例管理(ACM)和2)改良直接观察疗法(MDOT)。336名无家可归和居住在边缘的艾滋病毒患者接受每天一次或每天两次的联合抗逆转录病毒治疗， 可检测到的病毒载量和430%的药片计数依从性将随机分配到每种情况(每种情况112例)。ACM干预将作为旧金山公共卫生部资助的持续遵守支持计划的一部分提供。MDOT计划将在我们目前位于旧金山Tenderloin区的店面研究地点运行。HIV抗逆转录病毒治疗的依从性将通过未公布的药片数量和Audio-Cas1患者访谈法来衡量。我们将调查这两种干预措施对四个具体领域的影响：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，4)干预措施的成本效益。在为期6个月的干预期间和干预后的6个月期间，将每季度对结果进行评估，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.