Unified Intervention to Impact HIV Care Continuum

统一干预措施影响艾滋病毒护理的连续性

• 批准号: 9328030
• 负责人: Lisa A Eaton
• 金额: $ 70.36万
• 依托单位: UNIVERSITY OF CONNECTICUT STORRS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9328030
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adolescent and Young Adult; Age; Alcohol consumption; Alcohol or Other Drugs use; Behavioral; Car Phone; Caring; Clinic; Clinical Trials; Continuity of Patient Care; Counseling; Data; Diagnosis; Dose; Drops; Economics; Elements; Enrollment; Epidemic; Face; Geographic Locations; Goals; HIV; HIV Infections; HIV Seropositivity; HIV-infected adolescents; Health; Human immunodeficiency virus test; Immune system; Incidence; Individual; Infection; Informal Social Control; Intervention; Left; Link; Long-Term Care; Longitudinal Studies; Medical; Modeling; Motivation; Outcome; Participant; Persons; Phonation; Pilot Projects; Population; Prevalence; Prevention; Problem Solving; RNA; Randomized; Records; Relapse; Research; Risk; Running; Services; Source; Techniques; Telephone; Testing; Text; Time; Treatment outcome; United States National Institutes of Health; Viral; Virus Replication; Work; Youth; alcohol and other drug; antiretroviral therapy; base; black men who have sex with men; clinical care; comparative; cost; cost effective; cost effectiveness; economic evaluation; effective intervention; evidence base; health disparity; improved; medical appointment; medication compliance; motivational enhancement therapy; number theory; outreach; prevent; randomized trial; skills; social; social media; social stigma; substance using adolescents; theories; therapy adherence; therapy design; transmission process; treatment adherence; young adult

This pragmatic adaptive clinical trial will test the effects of a Stigma-Motivational-Decision intervention designed to increase HIV treatment engagement, retention, and medication adherence for substance using adolescents and young adults (AYA) living with HIV who are not in clinical care. The intervention uses a uniquely unified counseling approach at multiple points along the HIV continuum of care. In a first step, we will use multiple modes of outreach including social media, passive media, clinic records, and chain referrals to seek and identify HIV positive AYA (age 16 to 25) who are out of HIV care. In Step 2, HIV positive AYA who are out of HIV care and substance using will be enrolled in a phone-delivered counseling intervention to address substance use, HIV stigmas, medical care-related concerns, structural barriers, and other challenges to engaging youth in HIV care. Counseling will be provided weekly until the time participants are engaged in care, with a maximum of 12 sessions (up 3-months). We will therefore determine the number of theory-based phone intervention sessions needed (minimally effective dose) for care engagement and the associated costs. Once engaged in care, Step 3 will conduct a randomized trial to test the comparative effects and cost effectiveness of interactive text messaging with opportunities for ongoing supportive problem solving versus text message reminders to sustain long-term retention in care and medication adherence. HIV positive AYA are likely to drop out of care because of known challenges such as substance use, social barriers such as stigma, and concerns regarding treatment. Our 3-step study will use a single theory-based approach to determine the number of phone-delivered Stigma-Motivational-Decision counseling intervention sessions necessary to achieve engagement or re-engagement in HIV care, and will test the effects of a low-cost approach to sustaining long-term retention in care and medication adherence. Participants will be out of care at baseline and counseled with up to 12 weekly phone-delivered intervention sessions until they confirm engagement in HIV care. The study will determine the minimally effective counseling dose needed to engage substance using HIV positive AYA in care. Once participants attend HIV medical appointments, they will be randomized to either: (a) 15-months of ongoing weekly mobile phone text message check-ins with the opportunity for brief problem-focused phone support or (b) weekly text message reminders. The study will test the effects of the counseling and text messaging interventions on maintaining HIV care retention, medication adherence, and HIV viral suppression over 18-months. The primary endpoint in this trial is HIV RNA suppression. We will perform economic evaluations to determine the cost-effectiveness of the engagement-retention-adherence intervention. The proposed pragmatic adaptive trial will therefore determine the minimally effective dose of counseling and the effects of a low-burden retention/adherence intervention to maintain retention in care and avoid relapse to non-adherence for AYA living with HIV.

这项务实的自适应临床试验将测试污名动机干预的影响 旨在增加使用艾滋病毒治疗，保留率和药物依从性 不在临床护理中的艾滋病毒的青少年和年轻人（AYA）。干预使用 在艾滋病毒连续体的多个点上，独特的统一咨询方法。第一步，我们将 使用多种宣传方式，包括社交媒体，被动媒体，诊所记录和连锁转介 寻求并确定不受艾滋病毒护理的艾滋病（16至25岁）。在步骤2中，艾滋病毒阳性aya 不受艾滋病毒护理和使用的物质，将参加电话交付的咨询干预措施 解决药物使用，艾滋病毒污名，与医疗相关的问题，结构性障碍和其他挑战 吸引青年从事艾滋病毒护理。咨询将每周提供，直到参与者参与的时间 护理，最多12个会议（增加了3个月）。因此，我们将确定基于理论的数量 需要电话干预课程（最低限制剂量）以进行护理和相关费用。 一旦进行护理，步骤3将进行随机试验以测试比较效果和成本 交互式文本消息的有效性以及持续的支持问题解决的机会 短信提醒以维持在护理和药物遵守方面的长期保留。艾滋病毒阳性aya 由于已知的挑战，例如使用物质，社会障碍，例如 污名和对治疗的担忧。我们的三步研究将使用基于理论的单一方法来 确定电话传递的污名 - 动机 - 动机咨询干预会议 为了实现艾滋病毒护理的参与或重新参与所必需的，并将测试低成本的影响 维持长期保留在护理和药物依从性方面的方法。参与者将退出 基线护理，并为每周提供12次电话干预课程提供咨询直到他们 确认参与艾滋病毒护理。该研究将确定所需的最小有效咨询剂量 使用HIV阳性AYA在护理中参与物质。一旦参与者参加艾滋病毒医疗预约， 他们将被随机分配给：（a）正在进行的每周手机短信签到15个月 有机会进行简短的以问题为中心的电话支持或（b）每周的短信提醒。这 研究将测试咨询和文本消息干预措施对维持艾滋病毒护理的影响 在18个月以上的保留，药物依从性和HIV病毒抑制。此的主要终点 试验是HIV RNA抑制。我们将进行经济评估，以确定 退休 - 依从性干预。因此，拟议的务实的自适应试验将 确定咨询的最小有效剂量以及低负荷保留/依从性的影响 干预以保持护理的保留率，并避免因艾滋病毒而不遵守艾滋病毒的不遵守。