Abstract：
OBJECTIVE: In China, more than 30% of patients have not initiated treatment within 30 days of HIV diagnosis. Delayed initiation has a detrimental influence on disease outcomes and increases HIV transmission. The study aims to evaluate the effectiveness of a nurse-led antiretroviral therapy initiation nudging intervention for people newly diagnosed with HIV in China to find the optimal intervention implementation strategy.
METHODS: A Hybrid Type II sequential multiple assignment randomized trial will be conducted at four Centers for Disease Control and Prevention in Hunan, China. This study will recruit 447 people newly diagnosed with HIV aged ≥18 years and randomly assign them into two intervention groups and one control group. On top of the regular counselling services and referrals, intervention groups will receive a 4-week, 2-phase intervention based on the dual-system theory and the nudge theory. The control group will follow the currently recommended referral procedures. The primary outcomes are whether treatment is initiated, as well as the length of time it takes. The study outcomes will be measured at the baseline, day 15, day 30, week 12, week 24 and week 48. Generalized estimating equations and survival analysis will be used to compare effectiveness and explore factors associated with antiretroviral therapy initiation. Both qualitative and quantitative information will be collected to assess implementation outcomes.
CONCLUSIONS: Existing strategies mostly target institutional-level factors, with little consideration given to patients\' decision-making. To close this gap, we aim to develop an effective theory-driven nudging strategy to improve early ART initiation.
CONCLUSIONS: This nurse-led study will help to prevent delayed initiation by employing implementation science strategies for people newly diagnosed with HIV. This study contributes to the United Nations\' objective of ending the AIDS pandemic by 2030.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2300070140. The trial was prospectively registered before the first participant was recruited.
UNASSIGNED: The nudging intervention was finalized through the Nominal Group Technique where we invited five experts in the related field and five people living with HIV to participate.
METHODS: A Hybrid Type II sequential multiple assignment randomized trial will be conducted at four Centers for Disease Control and Prevention in Hunan, China. This study will recruit 447 people newly diagnosed with HIV aged ≥18 years and randomly assign them into two intervention groups and one control group. On top of the regular counselling services and referrals, intervention groups will receive a 4-week, 2-phase intervention based on the dual-system theory and the nudge theory. The control group will follow the currently recommended referral procedures. The primary outcomes are whether treatment is initiated, as well as the length of time it takes. The study outcomes will be measured at the baseline, day 15, day 30, week 12, week 24 and week 48. Generalized estimating equations and survival analysis will be used to compare effectiveness and explore factors associated with antiretroviral therapy initiation. Both qualitative and quantitative information will be collected to assess implementation outcomes.
CONCLUSIONS: Existing strategies mostly target institutional-level factors, with little consideration given to patients\' decision-making. To close this gap, we aim to develop an effective theory-driven nudging strategy to improve early ART initiation.
CONCLUSIONS: This nurse-led study will help to prevent delayed initiation by employing implementation science strategies for people newly diagnosed with HIV. This study contributes to the United Nations\' objective of ending the AIDS pandemic by 2030.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2300070140. The trial was prospectively registered before the first participant was recruited.
UNASSIGNED: The nudging intervention was finalized through the Nominal Group Technique where we invited five experts in the related field and five people living with HIV to participate.
摘要：
目标：在中国，超过30%的患者在HIV诊断后30天内未开始治疗.延迟启动对疾病结局有不利影响，并增加艾滋病毒传播。该研究旨在评估以护士为主导的抗逆转录病毒疗法对中国新诊断为HIV的人群的干预效果，以找到最佳的干预实施策略。
方法：将在湖南四个疾病预防控制中心进行II型混合序贯多重分配随机试验，中国。这项研究将招募447名年龄≥18岁的新诊断为HIV的人，并将他们随机分为两个干预组和一个对照组。除了定期的咨询服务和转介之外，干预组将接受为期4周的培训，基于双系统理论和微推理论的两阶段干预。对照组将遵循目前推荐的转诊程序。主要结果是是否开始治疗，以及它需要的时间长度。研究结果将在基线测量，第15天，第30天，第12周，第24周和第48周。广义估计方程和生存分析将用于比较有效性并探索与抗逆转录病毒治疗开始相关的因素。将收集定性和定量信息，以评估执行结果。
结论：现有策略主要针对机构层面的因素，很少考虑患者的决策。为了缩小这个差距，我们的目标是开发一种有效的理论驱动的推动策略，以改善早期ART启动。
结论：这项由护士主导的研究将通过对新诊断为HIV的人采用实施科学策略来帮助防止延迟启动。这项研究有助于联合国到2030年结束艾滋病流行的目标。
背景：中国临床试验注册ChiCTR2300070140。该试验在招募第一位参与者之前进行了前瞻性登记。
■通过名义小组技术最终确定了推动干预措施，我们邀请了相关领域的五名专家和五名艾滋病毒感染者参加。
方法：将在湖南四个疾病预防控制中心进行II型混合序贯多重分配随机试验，中国。这项研究将招募447名年龄≥18岁的新诊断为HIV的人，并将他们随机分为两个干预组和一个对照组。除了定期的咨询服务和转介之外，干预组将接受为期4周的培训，基于双系统理论和微推理论的两阶段干预。对照组将遵循目前推荐的转诊程序。主要结果是是否开始治疗，以及它需要的时间长度。研究结果将在基线测量，第15天，第30天，第12周，第24周和第48周。广义估计方程和生存分析将用于比较有效性并探索与抗逆转录病毒治疗开始相关的因素。将收集定性和定量信息，以评估执行结果。
结论：现有策略主要针对机构层面的因素，很少考虑患者的决策。为了缩小这个差距，我们的目标是开发一种有效的理论驱动的推动策略，以改善早期ART启动。
结论：这项由护士主导的研究将通过对新诊断为HIV的人采用实施科学策略来帮助防止延迟启动。这项研究有助于联合国到2030年结束艾滋病流行的目标。
背景：中国临床试验注册ChiCTR2300070140。该试验在招募第一位参与者之前进行了前瞻性登记。
■通过名义小组技术最终确定了推动干预措施，我们邀请了相关领域的五名专家和五名艾滋病毒感染者参加。
