Mitigating the Impact of Stigma and Shame as a Barrier to Viral Suppression Among MSM Living with HIV and Substance Use Disorders

减轻耻辱感和羞耻感对感染艾滋病毒和药物滥用的 MSM 的病毒抑制造成的影响

• 批准号: 10683694
• 负责人: Abigail Winston Batchelder
• 金额: $ 79.91万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10683694
• 关键词: 2 arm randomized control trial; Address; Adherence; Adoption; Appointment; Area; Automobile Driving; Awareness; Behavior Therapy; Behavioral; Behavioral Sciences; Boston; Caring; Case Manager; Cognition; Communicable Diseases; Communities; Compassion; Data; Drug user; Educational process of instructing; Emotions; Epidemic; Feedback; Florida; Future; Goals; HIV; Health; Hybrids; Inequity; Intervention; Location; Maintenance; Massachusetts; Mediating; Mediator; National Institute of Drug Abuse; Outcome; Outcome Measure; Participant; Persons; Positioning Attribute; Public Health; Race; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Resources; Risk; San Francisco; Self Care; Self Efficacy; Severities; Shame; Site; Social Work; Substance Use Disorder; Telephone; Text; Text Messaging; Time; Treatment Efficacy; Viral; Viral Load result; Visit; acceptability and feasibility; arm; comparison control; cost effectiveness; effectiveness evaluation; efficacy evaluation; evidence base; experience; follow-up; gender minority; gender minority group; housing instability; hybrid type 1 study; hybrid type 2 trial; implementation design; implementation strategy; implementation study; improved; informant; innovation; internalized stigma; men; men who have sex with men; prevent; service engagement; sex; skills; social; social stigma; substance use; substance use treatment; therapy design; transmission process; viral rebound; virtual delivery; virtual therapy

ABSTRACT Men who have sex with men (MSM) make up 69% of people living with HIV in the US. Among MSM and gender minority individuals who have sex with men living with HIV, substance use disorders (SUDs) are associated with inadequate engagement in HIV care, often leading to episodic unsuppressed viral load (VL) or viral rebound, thus driving the epidemic through elevated HIV transmission risk. Behavioral science identifies that internalized stigmas perpetuated by experienced stigma and structural inequities, influences sub-optimal engagement in HIV care, resultant unsuppressed VL, and transmission among MSM with SUDs. Stigma and related emotions (e.g., shame) compromise health outcomes both directly (e.g., via sub-optimal adherence and appointment attendance) and indirectly (e.g., as barriers to social services engagement). Interventions are needed to address stigma and shame as barriers to viral suppression among MSM and gender minority individuals living with HIV and SUDs. To meet this need, we developed, refined, and conducted a pilot RCT (K23DA043418) to assess the feasibility and acceptability of the MATTER intervention, an evidence- and community- informed psychobehavioral intervention to facilitate viral suppression by reducing the impact of internalized stigma and shame on engagement in HIV care among MSM with SUDs. The MATTER intervention aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of cognitions and emotions), and c) compassionate self-restructuring (i.e., self- compassion). It involves 5- one-on-one virtual therapy sessions and bidirectional personalized text messaging to extend the impact of the intervention while using less interventionist time and phone- based resource navigation. The proposed hybrid type 1 efficacy-implementation study will use the RE- AIM framework to assess: 1) the efficacy of the MATTER intervention on viral suppression at the final 12-month follow up visit compared to a time-matched control arm using a fully powered randomized controlled trial (RCT; N=256), 2) the proposed mechanisms of the MATTER intervention to inform future interventions to mitigate the impact of stigma, and 3) facilitators and barriers to the reach, adoption, implementation, and maintenance of the MATTER intervention to be conducted in two priority locations with key differences: the Boston, Massachusetts and Miami, Florida metro areas. Should the intervention be efficacious, and the innovative internalized stigma mitigation approach be confirmed, we will be well- positioned to leverage the identified facilitators and barriers to implementing this intervention among MSM and gender minority people who have sex with men living with HIV and SUDs in a subsequent hybrid type 2 trial to assess the scalability, including a full cost-effectiveness assessment.

抽象的 在美国，男男性行为者 (MSM) 占艾滋病病毒感染者的 69%。在 MSM 和 与感染艾滋病毒的男性发生性行为的性别少数群体，物质使用障碍（SUD）是 与艾滋病毒护理参与不足有关，常常导致偶发性病毒载量不受抑制 (VL) 或病毒反弹，从而通过增加艾滋病毒传播风险来推动流行病。行为方面 科学发现，因经历过的耻辱和结构性不平等而长期存在的内在耻辱， 影响 HIV 护理的次优参与、由此导致的未抑制的 VL 和传播 MSM 与 SUD。耻辱和相关情绪（例如羞耻）直接损害健康结果 （例如，通过次优遵守和预约出勤）和间接（例如，作为社交障碍） 服务参与）。需要采取干预措施来解决耻辱和羞耻作为病毒传播的障碍 对 MSM 和性别少数感染艾滋病毒和 SUD 的人进行压制。为了满足这种需求， 我们开发、完善并进行了一项试点 RCT (K23DA043418)，以评估可行性和 物质干预的可接受性，这是一种基于证据和社区的心理行为干预 通过减少内在耻辱和羞耻的影响来促进病毒抑制的干预措施 MSM 与 SUD 参与艾滋病毒护理。 MATTER 干预旨在减轻 内化的耻辱和羞耻对病毒抑制的负面行为后果： 行为自我保健目标设定技能和相关的自我效能，b）提高元认知意识 （即对认知和情感的非评判性意识），以及 c) 富有同情心的自我重组 （即自我同情）。它涉及 5 个一对一的虚拟治疗课程和双向个性化治疗 短信以扩大干预的影响，同时减少干预时间和电话 基于资源的导航。拟议的混合 1 型功效实施研究将使用 RE- AIM 框架评估：1）最终 MATTER 干预对病毒抑制的功效 与使用全动力随机试验的时间匹配对照组相比，进行 12 个月的随访 对照试验（RCT；N=256），2）提议的 MATTER 干预机制，以告知未来 减轻耻辱影响的干预措施，以及 3) 影响范围、采用的促进因素和障碍， 将在两个优先地点实施和维护 MATTER 干预措施 主要区别在于：马萨诸塞州波士顿和佛罗里达州迈阿密都市区。如果干预 如果有效，并且创新的内部耻辱减轻方法得到证实，我们将很好地- 能够利用已确定的促进因素和障碍来实施这一干预措施 MSM 以及与 HIV 感染者和 SUD 感染者发生性行为的性别少数群体 混合类型 2 试验评估可扩展性，包括全面的成本效益评估。