Making universal, free-of-charge antiretroviral therapy work for sexual and gender minority youth in Brazil

为巴西的性少数群体和性别少数青年提供普遍、免费的抗逆转录病毒治疗

• 批准号: 10274560
• 负责人: Katie Brooks Biello
• 金额: $ 22.78万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10274560
• 关键词: 19 year old; Address; Adherence; Age; Agreement; Anti-Retroviral Agents; Appointment; Attention; Behavioral; Behavioral Model; Bisexual; Brazil; Caring; Charge; Clinic; Cognitive; Communities; Counseling; Cues; Data; Development; Dose; Ensure; Face; Feedback; Focus Groups; Fostering; Funding; Future; Gays; Goals; HIV; HIV Infections; HIV Seropositivity; Health; Healthy Eating; Hour; Incidence; Individual; Institutes; Intervention; Interview; Measures; Mediator of activation protein; Medical; Medical Records; Methods; Moods; Morbidity - disease rate; Motivation; National Institute of Mental Health; Outcome; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacy facility; Phase; Plasma; Population; Population Intervention; Prevalence; Prevention; Problem Solving; Procedures; Process; Provider; Qualitative Research; Randomized; Randomized Controlled Trials; Records; Reporting; Research; Risk; Self Efficacy; Services; Sexual Transmission; Sexual and Gender Minorities; Sexual and Gender Minority Youth; Social support; Standardization; Structure; Technology; Testing; Text Messaging; Theoretical model; Time; Transportation; Travel; Viral; Viral Load result; Work; Youth; aged; antiretroviral therapy; arm; base; efficacy trial; experience; group counseling; group intervention; improved; improved outcome; informant; men; mortality; pilot trial; post intervention; pre-exposure prophylaxis; primary outcome; programs; recruit; service organization; side effect; skills; social; social stigma; standard of care; substance use; theories; therapy adherence; therapy development; transgender women; transmission process; treatment adherence; treatment program

Background. Sexual and gender minority (SGM) youth account for the largest number of incident HIV infections in Brazil. Although HIV can be managed with ongoing antiretroviral therapy (ART), exceptionally high levels of adherence are required. Brazil has implemented a comprehensive HIV treatment program with broad access to ART, but this program does not specifically address barriers to optimal ART adherence, particularly for SGM youth who experience many challenges taking their medication as prescribed. Overview. This application seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among HIV infected SGM youth (ages 15-24) in Rio de Janeiro, Brazil. The intervention aims to improve social support, self-efficacy for taking ART, and teach skills for problem-solving barriers to promote better adherence. To inform the content, structure, and format of the proposed intervention, the MPIs recently conducted focus groups with SGM youth (N = 18) and key informant interviews (N = 7) with medical providers and staff at local HIV service organizations working closely with SGM youth in Rio de Janeiro. Across focus groups and key informant interviews there was universal agreement that an intervention should capitalize on and enhance social support structures among SGM youth, and address their specific concerns, especially as related to the individual (e.g., ART side effects, mood, substance use), social (e.g., HIV/SGM stigma), and structural (e.g., clinic hours, transportation challenges) barriers that they regularly face. Theoretical Model. The intervention is guided by Social Cognitive and Social Support Theories and is grounded in the social and contextual realities of SGM youth living with HIV in Brazil. Specifically, social support is emphasized and informational, problem-solving and cognitive-behavioral “steps” are addressed over 4-group adherence counseling sessions, which include short video vignettes that seek to normalize adherence challenges. In addition, daily tailored SMS text messages are delivered as part of the intervention to facilitate social-cognitive cues to take medications as prescribed. Research Plan. Phase 1: Refine and enhance participant acceptability of the intervention and resolve any issues with intervention delivery/implementation; this will be achieved by convening and obtaining feedback from our youth community advisory board throughout this phase and subsequent phases; and by conducting an open-phase pilot with up to 12 SGM youth, with post-intervention exit interviews, as well as obtaining feedback from our youth community advisory board throughout this and subsequent phases. Phase 2: Examine, in a pilot randomized controlled trial, the feasibility, acceptability and potential impact of the proposed intervention among 72 SGM youth who will be equally randomized to the intervention or a time- and attention-matched control condition with standard of care. The outcomes are improved ART adherence (Wisepill, pharmacy assessment and self-report), retention in care and viral load suppression. Study assessments will be conducted at baseline, 3- and 6-months.

背景性和性别少数（SGM）青年占艾滋病毒事件的最大数量 巴西的感染。虽然艾滋病毒可以通过持续的抗逆转录病毒疗法（ART）进行管理，但异常高的感染率仍然存在。 需要一定程度的遵守。巴西实施了一项全面的艾滋病毒治疗计划， 获得抗逆转录病毒治疗，但该计划并没有专门解决最佳抗逆转录病毒治疗依从性的障碍，特别是 对于SGM青少年谁经历了许多挑战，服用他们的药物处方。概况.这 申请旨在开发和试点测试一个基于理论的，综合技术和咨询干预 提高巴西里约热内卢感染艾滋病毒的SGM青年（15-24岁）的抗逆转录病毒治疗依从性。的 干预的目的是改善社会支持，自我效能采取抗逆转录病毒疗法，并教授解决问题的技能 障碍，以促进更好地遵守。告知拟议干预的内容、结构和形式， MPI最近与SGM青年（N = 18）进行了焦点小组讨论，并与 与里约SGM青年密切合作的当地艾滋病毒服务组织的医疗提供者和工作人员 里约热内卢。在焦点小组和关键知情人访谈中，普遍认为干预措施 应利用和加强SGM青年的社会支持结构， 问题，特别是与个人有关的问题（例如，ART副作用、情绪、物质使用）、社会（例如， 艾滋病毒/SGM耻辱）和结构性（例如，门诊时间，交通挑战）他们经常面临的障碍。 理论模型。干预以社会认知和社会支持理论为指导， 基于巴西感染艾滋病毒的SGM青年的社会和背景现实。具体来说，社会 支持是强调和信息，解决问题和认知行为的“步骤”是解决了 4-小组依从性咨询会议，其中包括寻求使依从性正常化的短视频小插曲 挑战此外，作为干预措施的一部分，每天发送量身定制的短信， 社会认知线索来按处方服药。研究计划。阶段1：优化和增强 参与者对干预措施的可接受性，并解决干预措施交付/实施的任何问题; 这将通过召集我们的青年社区咨询委员会并获得其反馈来实现 在本阶段和随后的阶段;并通过进行不超过12个SGM的开相试验 青年，与干预后的离职面谈，以及从我们的青年社区咨询机构获得反馈， 在这一阶段和随后的阶段。第2阶段：在一项初步随机对照试验中， 可行性，可接受性和72 SGM青年谁将拟议的干预措施的潜在影响 同样随机分配到干预组或时间和注意力匹配的标准治疗对照组。 结果是改善了ART依从性（Wisepill、药房评估和自我报告）， 护理和病毒载量抑制。将在基线、3个月和6个月时进行研究评估。