PWID Opportunities to Improve TrEat and Retain (POINTER)

注射吸毒者改善治疗和保留的机会 (POINTER)

• 批准号: 10237849
• 负责人: GREGORY M LUCAS
• 金额: $ 104.33万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10237849
• 关键词: Address; Adoption; Africa; African; Caring; Cities; Clinic; Communities; Continuity of Patient Care; Cost Effectiveness Analysis; Country; Data; Decentralization; Diagnosis; Effectiveness; Epidemic; Evaluation; Evidence based intervention; Foundations; Government; HIV; HIV Infections; HIV Seropositivity; Health; Health Policy; Human immunodeficiency virus test; Incidence; Income; India; Individual; Injecting drug user; Injections; Intervention; Link; Modeling; Needle Sharing; Opioid; Opium; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Policies; Population; Prevalence; Price; Production; Publishing; Randomized; Randomized Controlled Trials; Respondent; Sampling; Site; Social Network; System; Testing; Time; Treatment outcome; Viral; Visit; Work; arm; base; community based care; cost; cost effectiveness; design; effectiveness implementation study; eligible participant; experience; follow-up; high risk; implementation facilitators; implementation science; improved; insight; intervention cost; intervention effect; low and middle-income countries; motivational enhancement therapy; novel; opioid use; opioid user; primary outcome; psychosocial; randomized trial; recruit; response; scale up; skills; testing uptake

7. PROJECT SUMMARY/ABSTRACT People who inject drugs (PWID) are at high risk for HIV infection and experience worse treatment outcomes than other key populations, particularly in low to middle income countries (LMIC). Opioid use is common in India and new injection drug epidemics have emerged in the North and Central regions of the country in the last 5-10 years. In these regions, we have documented high rates of needle sharing, high HIV prevalence and incidence, and low access to HIV testing and treatment. Our team demonstrated the potential of respondent- driven sampling (RDS) to leverage social networks and identify unaware and out-of-care HIV-positive PWID. In response to RFA-DA-18-017, we propose to build on our experience with RDS as the foundation of “seek and test”, by rigorously assessing three scalable strategies aimed at improving the “treat and retain” steps of the HIV care continuum among PWID in a LMIC setting. Aim 1 is to conduct a factorial randomized controlled trial to evaluate the individual and combined effects of a policy intervention (same-day ART), a structural intervention (community-based care) and an individual-level intervention (psychosocial/ navigation) to improve treatment outcomes among HIV-positive PWID. A factorial design can assess both the main effects of multiple interventions and interactions between the interventions, offering the potential for trial efficiency (effectively getting 3 trials for the price of one) and novel insights on how interventions with different mechanisms may influence the effectiveness of one another. We will test 3 hypotheses: Hypothesis 1A - Same-day ART initiation will increase 12-month survival with viral suppression among HIV-positive PWID, compared with standard ART initiation. Same-day ART has been found effective in Africa, but has never been evaluated in PWID. Hypothesis 1B - Community-based care will increase 12-month survival with viral suppression among HIV-positive PWID, compared with government-based care. In prior work, we found that PWID-centric integrated care centers (ICCs) were highly effective at engaging the population, providing opioid treatment and increasing HIV testing uptake. Here we propose to scale-up the ICC model to provide community-based HIV care in an accessible and non-discriminatory setting. Hypothesis 1C - A psychosocial/navigation intervention (enhanced support) will increase 12-month survival with viral suppression among HIV-positive PWID, compared with standard support. Patient navigators will provide PWID-focused motivational interviewing, skills building, and field-based systems navigation and retention. We propose to adapt and build upon evidence-based interventions for PWID. Durability of intervention effects will be assessed at 18 months. Aim 2 is to characterize the barriers and facilitators to implementation of the proposed interventions, and determine the intervention costs and potential cost-effectiveness. We will characterize implementation pathways with a dedicated implementation science evaluation following the Curran type-1 model of an effectiveness-implementation hybrid study and will conduct formal cost-effectiveness analyses.

7.项目总结/摘要 注射吸毒者（PWID）感染艾滋病毒的风险很高，治疗效果较差 特别是在中低收入国家（LMIC）。阿片类药物的使用很常见， 2010年，印度北部和中部地区出现了新的注射毒品流行病， 过去5-10年。在这些地区，我们记录了共用针头的高比率、艾滋病毒的高流行率， 艾滋病毒感染率低，获得艾滋病毒检测和治疗的机会少。我们的团队展示了答辩人的潜力- 驱动采样（RDS），以利用社交网络，并确定不知情和护理外的艾滋病毒阳性的PWID。在 作为对RFA-DA-18-017的回应，我们建议将我们在RDS方面的经验作为基础， “寻求和测试”，通过严格评估三个可扩展的战略，旨在改善“治疗和测试”， 在低收入中等收入国家的艾滋病毒感染者中保留”艾滋病毒护理连续性的步骤。目标1是进行阶乘 随机对照试验，以评估政策干预的个体和综合效应（同一天 抗逆转录病毒疗法）、结构性干预（基于社区的护理）和个人层面的干预（心理社会/ 导航），以改善艾滋病毒阳性PWID的治疗结果。析因设计可以评估 多种干预措施的主要影响和干预措施之间的相互作用，为试验提供了可能性 效率（有效地获得3个试验的价格为一个）和新的见解，如何干预与不同的 机制可能会影响彼此的有效性。我们将测试3个假设：假设1A - 在HIV阳性的PWID中，同一天开始ART治疗将增加病毒抑制的12个月生存率， 与标准抗逆转录病毒疗法相比。同一天的ART在非洲被发现有效，但从未被发现 在PWID中进行评估。假设1B -基于社区的护理将增加12个月的生存与病毒 与政府提供的护理相比，在之前的工作中，我们发现， 以PWID为中心的综合护理中心（ICC）在吸引人群方面非常有效， 治疗和提高艾滋病毒检测率。在这里，我们建议扩大ICC模型，以提供 在无障碍和非歧视的环境中提供基于社区的艾滋病毒护理。假设1C-A 心理社会/导航干预（增强支持）将增加病毒抑制的12个月生存率 与标准支持相比，艾滋病毒阳性的PWID。患者导航器将提供以PWID为重点的 激励性面试、技能建设以及基于实地的系统导航和保留。我们建议 调整并建立基于证据的PWID干预措施。将评估干预效果的持久性 18个月大的时候目标2是描述执行拟议的 干预措施，并确定干预成本和潜在的成本效益。我们将描述 实施途径，并按照Curran类型1进行专门的实施科学评价 这是一个有效性-执行混合研究的模式，并将进行正式的成本效益分析。