Developing a U.S. National Cohort to Improve Virologic Suppression among Stimulant-using Men Living with HIV.

建立美国国家队列以改善使用兴奋剂的艾滋病毒男性感染者的病毒抑制。

• 批准号: 10675863
• 负责人: Adam Wayne Carrico
• 金额: $ 105.44万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10675863
• 关键词: 2 arm randomized control trial; 2019-nCoV; Achievement; Address; Adherence; Affect; African American; Behavior Therapy; Black race; Caring; Clinical Research; Cocaine; Counseling; Crack Cocaine; Data; Drug Monitoring; Emotions; Enrollment; Epidemic; Feedback; Goals; HIV; HIV antiretroviral; Hair; Human immunodeficiency virus test; Individual; Intervention; Maintenance; Measures; Methamphetamine; Mobile Health Application; Modeling; Monitor; Moods; Motivation; Namibia; Nature; Outcome; Participant; Patient Recruitments; Patient Self-Report; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Prevalence; Randomized; Randomized, Controlled Trials; Research; Sampling; Self Administration; Site; Social Network; Stimulant; Structural Racism; Subgroup; Surveys; Techniques; Tenofovir; Test Result; Testing; Therapeutic; Time; Underserved Population; Urine; Venous blood sampling; Viremia; Visit; Work; antiretroviral therapy; cohort; cost; digital; efficacy testing; evidence base; experience; health care service utilization; home test; improved; incremental cost; intervention effect; mHealth; men; men who have sex with men; microcosting; multi-component intervention; novel; point of care; point of care testing; primary outcome; randomized, clinical trials; recruit; resilience; response; secondary outcome; sexual minority men; smartphone application; social; social stigma; standard of care; stimulant use; structural determinants; therapy adherence; tool; treatment adherence

PROJECT SUMMARY/ ABSTRACT A resurgent stimulant epidemic among sexual minority men/men who have sex with men, including those living with HIV, could compromise the U.S. Ending the HIV Epidemic goals by interfering with HIV care engagement, adherence, and virologic suppression among sexual minority men living with HIV. Prominent multi-level barriers interfere with HIV virologic suppression among sexual minority men living with HIV, particularly among those who use stimulants. We will digitally recruit at least 1,000 sexual minority men living with HIV, of whom at least 40% will identify as Black/African-American and at least 70% will have active stimulant use to identify multi-level determinants of HIV care engagement, adherence, and virologic suppression among sexual minority men living with HIV, with and without stimulant use. Guided by the social ecological model, we will investigate network factors (HIV status, stimulant use), geospatial determinants (background stimulant use prevalence, EHE region), and other structural factors (intersectional stigma, structural racism) that affect virologic suppression (Aim 1). After recruitment milestones are met, we will perform a nested randomized clinical trial to test a multi-component intervention to improve virologic suppression, adherence, positive affect, and stimulant use among sexual minority men living with HIV who use stimulants (n=300). The intervention, known as reSTART, will combine an evidence-based positive affect intervention delivered through a smartphone app and use of urine point-of- care testing to perform adherence self-monitoring, with motivational messages to improve or maintain adherence delivered via the reSTART app (Aim 2). In Aim 3 of the proposal, we will assess the impact of reSTART on incremental cost per person on virologic suppression and optimal antiretroviral therapy adherence measured via hair tenofovir levels. By this high-impact study’s end, we will have identified multi-level determinants of the treatment continuum among digitally-recruited sexual minority men living with HIV, including among those who use stimulants; and the impact of a multi-component reSTART mHealth intervention using novel point-of-care adherence self- monitoring on HIV virologic suppression, adherence, and cost among a key underserved population.

项目摘要/摘要 性少数人群/与男性发生性行为的男子中兴奋剂流行死灰复燃 携带艾滋病毒，可能会通过干扰艾滋病毒护理来损害美国结束艾滋病毒流行的目标 性少数族裔艾滋病毒携带者的接触、坚持和病毒学抑制。突出 多层次障碍干扰艾滋病毒携带者性少数族裔男子艾滋病毒病毒学抑制， 尤其是在那些使用兴奋剂的人中。 我们将以数字方式招募至少1000名携带艾滋病毒的性少数族裔男性，其中至少40%的人将识别 作为黑人/非裔美国人，至少70%的人会积极使用兴奋剂来识别多水平的决定因素 性少数族裔艾滋病毒携带者中艾滋病毒关怀参与、坚持和病毒学抑制的情况， 使用和不使用兴奋剂。在社会生态模型的指导下，我们将调查网络因素(艾滋病毒 状态、兴奋剂使用)、地理空间决定因素(背景兴奋剂使用普及率、EHE地区)和其他 影响病毒学抑制的结构性因素(跨部门污名、结构性种族主义)(目标1)。之后 达到招募里程碑，我们将进行嵌套随机临床试验，以测试多组分 改善性行为中病毒学抑制、依从性、积极影响和兴奋剂使用的干预措施 使用兴奋剂的少数族裔艾滋病毒携带者(n=300)。这一被称为重启的干预措施将结合 通过智能手机应用程序和使用尿点进行的循证积极情绪干预 关怀测试以执行遵从性自我监控，并提供激励信息以改进或维护 通过重启应用程序(AIM 2)提供遵守。在建议的目标3中，我们将评估 重新启动每人增加的病毒学抑制费用和最佳抗逆转录病毒治疗依从性 通过头发中的替诺福韦水平来衡量。 到这项高影响力的研究结束时，我们将确定治疗连续体的多水平决定因素 在数码招募的性少数族裔艾滋病毒携带者中，包括在使用兴奋剂的人中；以及 使用新型看护点依从性自我护理的多组件重启mHealth干预的影响 在服务不足的关键人群中监测艾滋病毒病毒学抑制、依从性和成本。