Unified Intervention to Impact HIV Care Continuum

这项务实的适应性临床试验将测试污名-动机-决策干预的效果 旨在提高HIV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青壮年(Aya)。该干预使用 在艾滋病毒护理连续统一体的多个点上采用独特的统一咨询方法。在第一步，我们将 使用多种外展模式，包括社交媒体、被动媒体、诊所记录和连锁转介 寻找和识别未接受艾滋病毒护理的艾滋病毒阳性Aya(16岁至25岁)。在第二步中，HIV阳性的Aya Who 脱离艾滋病毒护理和药物使用的人将参加电话咨询干预，以 解决药物使用、艾滋病毒污名、与医疗有关的问题、结构性障碍和其他挑战 让青年参与艾滋病毒护理。咨询将每周提供，直到参与者参与到 护理，最多12次(3个月以上)。因此，我们将根据理论确定数量 护理参与所需的电话干预会议(最低有效剂量)和相关成本。 一旦参与护理，第三步将进行随机试验，以测试比较效果和成本 提供持续支持解决问题的机会的交互式短信的效率与 短信提醒，维持长期护理和服药依从性。HIV阳性Aya 可能会因为已知的挑战而退出护理，如物质使用，社会障碍，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来 确定电话传递的污名-动机-决策咨询干预会话的数量 实现艾滋病毒护理的参与或重新参与是必要的，并将测试低成本的效果 维持长期护理和服药依从性的方法。参赛者将离开 达到基线水平的护理，每周最多通过电话提供12次干预会议，直到他们 确认参与艾滋病毒护理。这项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的物质。一旦参与者参加艾滋病毒医疗预约， 他们将被随机分为：(A)为期15个月的每周手机短信签到 有机会获得简短的以问题为中心的电话支持或(B)每周短信提醒。这个 这项研究将测试咨询和短信干预对维持艾滋病毒护理的效果 18个月的保留期、服药依从性和HIV病毒抑制。此中的主端点 试验是抑制HIV RNA。我们将进行经济评估，以确定 敬业度-保持-坚持干预。因此，拟议的务实适应性审判将 确定咨询的最低有效剂量和低负担保留/坚持的效果 对感染艾滋病毒的Aya患者进行干预，以维持护理，并避免复发。

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.