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: 9233354
• 负责人: Lisa A Eaton
• 金额: $ 72.98万
• 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/9233354
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adolescent and Young Adult; Age; 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; Immune system; Incidence; Individual; Infection; Informal Social Control; Intervention; Left; Life; Link; Long-Term Care; Longitudinal Studies; Medical; Modeling; Outcome; Participant; Persons; Pilot Projects; Population; Prevalence; Prevention; Problem Solving; RNA; Randomized; Records; Relapse; Research; Risk; Running; Services; Source; Staging; Techniques; 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; evidence base; health disparity; improved; medical appointment; medication compliance; meetings; 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; treatment disparity; 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.

这项务实的适应性临床试验将测试耻辱动机决策干预的效果 旨在提高艾滋病毒治疗参与度、保留率和药物使用依从性 未接受临床护理的感染艾滋病毒的青少年和年轻人 (AYA)。干预措施使用了 在艾滋病毒连续护理过程中的多个点采用独特的统一咨询方法。第一步，我们将 使用多种外展模式，包括社交媒体、被动媒体、临床记录和连锁转介 寻找并识别未接受艾滋病毒护理的艾滋病毒阳性 AYA（16 至 25 岁）。在第 2 步中，HIV 呈阳性的 AYA 脱离艾滋病毒护理和药物滥用的人将参加电话提供的咨询干预，以 解决物质使用、艾滋病毒耻辱、医疗保健相关问题、结构性障碍和其他挑战 让年轻人参与艾滋病毒护理。将每周提供咨询，直到参与者参与 护理，最多 12 次（最多 3 个月）。因此，我们将确定基于理论的数量 护理参与所需的电话干预会议（最低有效剂量）和相关费用。 一旦进行护理，第3步将进行随机试验，以测试比较效果和成本 交互式短信的有效性以及持续支持性解决问题的机会 短信提醒，以维持长期保持护理和药物依从性。 HIV阳性的AYA 由于已知的挑战，例如药物滥用、社会障碍（例如 耻辱以及对治疗的担忧。我们的三步研究将使用单一的基于理论的方法 确定电话提供的耻辱动机决策咨询干预会议的数量 实现参与或重新参与艾滋病毒护理所必需的，并将测试低成本的效果 维持长期护理和药物依从性的方法。参加者将来自 基线护理，并通过每周最多 12 次的电话干预会议提供咨询，直到他们 确认参与艾滋病毒护理。该研究将确定所需的最低有效咨询剂量 在护理中使用 HIV 阳性 AYA 进行物质接触。一旦参与者参加艾滋病毒医疗预约， 他们将被随机分配到： (a) 15 个月内每周持续使用手机短信签到 有机会获得针对问题的简短电话支持或 (b) 每周短信提醒。这 研究将测试咨询和短信干预对维持艾滋病毒护理的影响 18 个月内的保留率、药物依从性和 HIV 病毒抑制。本次研究的主要终点 试验是HIV RNA抑制。我们将进行经济评估以确定成本效益 参与-保留-依从干预。因此，拟议的务实适应性试验将 确定咨询的最低有效剂量以及低负担保留/依从的效果 对感染艾滋病毒的 AYA 进行干预，以维持护理并避免复发。