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

针对新诊断男性的简短健康增强干预措施的功效试验

• 批准号: 8446271
• 负责人: NATHAN B HANSEN
• 金额: $ 57.11万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8446271
• 关键词: AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Acute; Address; Adherence; Anti-Retroviral Agents; Behavioral; Caring; Centers for Disease Control and Prevention (U.S.); Cognitive; Collaborations; Communities; Community Health Centers; Comprehensive Health Care; Counseling; Decision Making; Diagnosis; Disclosure; Drops; Early treatment; Enrollment; Funding; HIV; HIV Infections; HIV Seropositivity; HIV diagnosis; HIV risk; Health; Health behavior; Health care facility; Healthcare; Incidence; Intervention; Medical; Methods; Modeling; Motivation; National Institute of Mental Health; New York City; Newly Diagnosed; Participant; Patient Self-Report; Pharmaceutical Preparations; Preventive Intervention; Professional counselor; Randomized; Randomized Controlled Trials; Recruitment Activity; Reporting; Request for Applications; Research; Risk; Risk Behaviors; Risk Reduction; Secondary Prevention; Techniques; Testing; Training; Translating; Treatment Efficacy; United States National Institutes of Health; Viral Load result; Work; base; critical period; effective intervention; efficacy testing; efficacy trial; follow-up; improved; innovation; meetings; men; men who have sex with men; organizational structure; prevent; primary care setting; programs; sex; sex risk; skills; transmission process; treatment adherence; uptake

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.

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，占美国新艾滋病毒感染的61%，和男男性行为者是艾滋病发病率上升的唯一群体。艾滋病毒诊断后的第一年是干预的关键时期，因为许多男男性行为者未能进入或退出艾滋病毒护理，超过50%的新诊断的男男性行为者在诊断后3至12个月内报告艾滋病毒传播风险行为。几乎没有干预措施可以增加新诊断的男男性行为者的护理参与度并降低性风险。目的：这项拟议的研究建立在我们团队进行的形成性工作的基础上，旨在进行一项随机对照试验，以测试积极选择的有效性，这是一种针对新诊断为艾滋病毒的男男性行为者的简短健康促进和风险降低干预措施。积极的选择是与卡伦-洛德社区卫生中心合作开发的，在那里我们已经证明了干预的可行性，可接受性和潜在的有效性：（1）帮助新诊断的男性过渡到医疗保健;（2）将风险降低纳入综合护理;（3）利用接受艾滋病毒诊断所带来的机会之窗来改变性风险行为。研究方法：440名新诊断的HIV感染者（三个月内）将被随机分配到：（1）积极选择实验条件，或（2）个性化认知咨询比较条件，并随访一年。我们的社区合作伙伴卡伦-洛德社区卫生中心和哈莱姆联合社区艾滋病中心的艾滋病毒顾问将接受培训，以便在每种情况下提供干预措施。将在基线、3、6、9和12个月时进行评估。将对以下假设进行检验，以确定积极选择的有效性：实验条件下的受试者将（1）实现显著更大的HIV病毒载量抑制;（2）表现出更大的护理和治疗依从性;（3）在整个研究期间，与对照条件下的受试者相比，参与较少的性HIV传播风险行为。重要性：鉴于男男性行为者中艾滋病毒发病率的增加、艾滋病毒治疗的进步以及早期治疗在预防艾滋病毒传播方面已证明的有效性，迫切需要采取有效的干预措施，以增加男男性行为者对护理的参与和保留，并减少艾滋病毒的性传播风险行为。积极的选择是创新的重点是新的艾滋病毒诊断的男子，其整合的健康增强和减少风险的技术，并在卫生保健环境中实施，以协助过渡 新确诊的男性患者积极选择可以无缝集成到医疗保健中，并转化为新诊断的男男性行为者的可持续护理模式，以满足对识别、治疗和预防艾滋病毒感染的护理计划的迫切需求。