Unified Intervention to Impact HIV Care Continuum

这项实用的适应性临床试验将测试污名动机决策干预的效果 旨在增加艾滋病毒治疗的参与，保留和药物使用的药物依从性 未接受临床护理的艾滋病毒感染者青少年和年轻人。干预使用一个 在艾滋病毒连续护理的多个沿着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、诊所记录和连锁转诊， 寻找和识别艾滋病毒阳性的AYA（16至25岁），他们没有艾滋病毒护理。第二步，艾滋病毒阳性的AYA， 艾滋病毒护理和物质使用将被登记在一个电话提供的咨询干预， 解决药物使用、艾滋病毒污名、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。咨询将每周提供，直到时间参与者从事 护理，最多12次（最多3个月）。因此，我们将确定基于理论的 护理参与所需的电话干预会话（最低有效剂量）和相关成本。 一旦从事护理，步骤3将进行随机试验，以测试比较效果和成本 交互式短信的有效性，以及持续支持性问题解决的机会，而 短信提醒，以维持长期保持护理和药物依从性。HIV阳性AYA 由于已知的挑战，如物质使用，社会障碍， 耻辱和对治疗的担忧。我们的三步研究将使用单一的基于理论的方法， 确定电话提供的污名-动机-决策咨询干预会议的次数 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 维持长期护理和药物依从性的方法。参与者将在 在基线时进行护理，并通过每周最多12次的电话干预进行咨询， 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 让艾滋病毒阳性的AYA参与护理。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个月的每周移动的手机短信签到 有机会获得针对问题的简短电话支持或（B）每周短信提醒。的 一项研究将测试咨询和短信干预对维持艾滋病护理的影响 保持，药物依从性和HIV病毒抑制超过18个月。本研究的主要终点 HIV RNA抑制试验。我们将进行经济评估，以确定 即完成-保留-坚持干预。因此，拟议的务实适应性试验将 确定咨询的最低有效剂量和低负担保留/坚持的效果 采取干预措施，以保持对艾滋病毒感染者的护理，避免复发，不再坚持。

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.