Efficacy Trial of a Brief Health Enhancement Intervention for Newly Diagnosed Men

描述（由申请人提供）：问题：估计每年有29,300例新的艾滋病毒诊断发生在男男性行为者（MSM）中，占美国新感染艾滋病毒的61%，并且MSM是唯一一个艾滋病毒发病率增加的群体。艾滋病毒诊断后的第一年是干预的关键时期，因为许多男同性恋者未能进入或退出艾滋病毒治疗，超过50%的新诊断的男同性恋者在诊断后3至12个月内报告了艾滋病毒传播风险行为。很少有干预措施可以增加对新诊断的男男性行为者的参与和减少性风险。目的：本研究以我们团队的形成性工作为基础，旨在进行一项随机对照试验，以测试积极选择的有效性，积极选择是一种简短的健康增强和降低风险的干预措施，针对新诊断为艾滋病毒的男同性恋者。积极选择是与卡伦-洛德社区健康中心合作开发的，在那里我们已经证明了干预的可行性，可接受性和潜在的功效：(1)帮助新诊断的男性过渡到医疗护理；(2)将降低风险纳入综合护理；(3)利用接受艾滋病毒诊断提供的机会窗口改变性危险行为。方法：将440名新诊断为HIV的男性（三个月内）随机分配到：(1)积极选择实验条件或(2)个性化认知咨询比较条件，随访一年。我们的社区合作伙伴卡伦-洛德社区保健中心和哈莱姆联合社区艾滋病中心的艾滋病顾问将接受培训，以便在每种情况下提供干预措施。评估将在基线、3、6、9和12个月进行。我们将检验以下假设以确定积极选择的有效性：在实验条件下，参与者将(1)实现显著更大的HIV病毒载量抑制；(2)表现出更多的接受护理和坚持治疗；(3)在整个研究期间，与比较条件下的参与者相比，他们从事的性艾滋病毒传播风险行为较少。意义：鉴于男同性恋者中艾滋病发病率的上升，艾滋病治疗的进步，以及早期治疗在预防艾滋病传播方面的有效性，迫切需要有效的干预措施，以增加男同性恋者的参与和保留护理，并减少性艾滋病毒传播的风险行为。积极选择的创新之处在于，它把重点放在新诊断出艾滋病毒的男子身上，结合了增进健康和减少风险的技术，并在保健环境中实施，以协助过渡

DESCRIPTION (provided by applicant): Problem: An estimated 29,300 new HIV diagnoses occur each year among men who have sex with men (MSM), representing 61% of new HIV infections in the U.S., and MSM are the only group with an increasing HIV incidence. The first year following an HIV diagnosis is a critical period for intervention as many MSM fail to enter or drop out of HIV care and over 50% of newly diagnosed MSM report HIV transmission risk behavior within 3 to 12 months of diagnosis. Few interventions exist to increase engagement in care and reduce sexual risk among newly diagnosed MSM. Aims: The proposed research builds upon formative work conducted by our team and aims to conduct a randomized controlled trial to test the efficacy of Positive Choices, a brief health-enhancement and risk reduction intervention targeting newly HIV diagnosed MSM. Positive Choices was developed in collaboration with Callen-Lorde Community Health Center, where we have demonstrated the intervention's feasibility, acceptability and potential efficacy for (1) assisting newly diagnosed men in the transition into medical care; (2) integrating risk reduction into comprehensive care; and (3) taking advantage of a window of opportunity presented by receiving an HIV diagnosis to change sexual risk behavior. Methods: 440 newly HIV diagnosed (within three months) men will be randomly assigned to either: (1) the Positive Choices experimental condition, or (2) the Personalized Cognitive Counseling comparison condition and followed for one year. HIV counselors within our community partners, Callen-Lorde Community Health Center and Harlem United Community AIDS Center, will be trained to deliver the interventions within each condition. Assessments will be conducted at baseline, 3, 6, 9 and 12 months. The following hypotheses will be tested to establish the efficacy of Positive Choices: Participants in the experimental condition will (1) achieve significantly greater suppression of HIV viral load; (2) demonstrate greater uptake of care and adherence to treatment; and (3) engage in less sexual HIV transmission risk behavior across the study duration than participants in the comparison condition. Significance: Given increases in HIV incidence among MSM, advances in HIV treatment, and the demonstrated efficacy of early treatment in preventing HIV transmission, there is a critical need for effective interventions that can increase engagement and retention of MSM in care and reduce sexual HIV transmission risk behavior. Positive Choices is innovative in its focus on newly HIV diagnosed men, its integration of health enhancement and risk reduction techniques, and its implementation in the health care setting to assist in the transition of newly diagnosed men into care. Positive Choices can be seamlessly integrated into medical care and translated into a sustainable model of care for newly diagnosed MSM to meet the urgent need for care programs that identify, treat, and prevent HIV infections.