一项针对美国原住民的文化适应型 HIV 预防方法的随机对照试验，旨在减轻创伤症状与物质滥用：Healing Seasons 方案。
A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.
机构信息
Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
出版信息
Contemp Clin Trials. 2020 Aug;95:106070. doi: 10.1016/j.cct.2020.106070. Epub 2020 Jun 17.
UNLABELLED
Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.
METHODS
The Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16-29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity.
DISCUSSION
Behavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population.
TRIAL REGISTRATION
ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.
未加标签
美洲原住民（NA）经历着创伤暴露、物质使用和 HIV 风险行为的相互关联的风险，这使他们感染 HIV 的风险增加。尽管存在这些已知的风险因素，但很少有发表的随机试验测试针对 NA 减少创伤相关症状和物质滥用的干预措施。
方法
Healing Seasons 研究是一项针对两种咨询策略的随机比较试验，一种是针对 PTSD 的叙事暴露疗法（NET），另一种是针对物质滥用的动机性访谈与认知行为治疗技能培训（MIST），目的是预防 NA 中的 HIV 感染。该研究采用社区参与式研究方法，我们对这两种循证干预措施进行了调整，使其针对 NA 的风险背景和现实情况具有特异性，并包括心理教育和技能培养组成部分，其中包括具有文化特异性的故事、美德和传统治疗策略。参与者年龄在 16 岁及以上，从太平洋西北地区的一个部落社区招募，通过电话进行筛选，亲自登记，并按照 NET 或 MIST 的比例随机分组。我们按年龄（16-29 岁和 30 岁或以上）和性别（男性或女性）进行分层，以确保治疗组之间的平衡。主要结局指标是性伴侣数量和性行为频率（有无避孕套）、受物质影响下的性行为、物质使用频率和 PTSD 严重程度。
讨论
需要针对 NA 开展行为干预措施，以预防创伤症状和物质滥用导致的 HIV 风险行为。这项研究将提供证据，以确定针对相关风险因素进行咨询为基础的 HIV 预防干预措施的可行性和疗效，以减少该人群的性风险。
试验注册
ClinicalTrials.gov 编号，NCT03112369，于 2017 年 4 月 12 日注册。
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