Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
AIDS. 2021 Dec 1;35(15):2503-2511. doi: 10.1097/QAD.0000000000003049.
Many adolescents and young adults (AYA) have unmet HIV prevention needs. We describe the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings (PATC3H) consortium organization, transition milestones, and youth engagement strategies. The PATC3H consortium focuses on reducing HIV incidence and related health disparities among AYA.
Organizational data were obtained from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and supplemented with a brief survey completed by study principal investigators. Transition from the initial phase (years 1 and 2) to the subsequent phase (years 3 and 5) was contingent on meeting prespecified milestones. We reviewed the structure and function of the research consortium, identified shared elements of transition milestones, and examined common youth engagement strategies.
The PATC3H consortium supports eight research studies through a milestone transition mechanism. The consortium includes AYA HIV research studies in seven countries - Brazil, Kenya, Mozambique, Nigeria, South Africa, Uganda, and Zambia. The NIH request for applications required transition milestones that included early consultation with stakeholders. The transition milestones required by NIH for the eight studies included early consultation with health and policy stakeholders, pilot intervention data, and commitment from national government stakeholders. All studies provided multiple pathways for AYA engagement, including AYA advisory boards and youth-led research studies.
Data suggest that requiring milestones to transition to the final phase may have facilitated health and policy stakeholder engagement and enhanced formative assessment of regulatory protocols. These data have implications for designing engaged research studies in low and middle-income countries.
许多青少年和年轻人(AYA)有未满足的艾滋病毒预防需求。我们描述了预防和治疗通过综合关怀连续体艾滋病毒受影响的青少年在资源有限的环境中(PATC3H)联盟组织,过渡里程碑和青年参与战略。PATC3H 联盟专注于减少 AYA 中的艾滋病毒发病率和相关健康差距。
组织数据来自美国国立卫生研究院儿童健康与人类发展研究所(NICHD),并辅以研究主要研究者完成的简短调查。从初始阶段(第 1 年和第 2 年)过渡到后续阶段(第 3 年和第 5 年)取决于是否满足规定的里程碑。我们审查了研究联盟的结构和功能,确定了过渡里程碑的共同要素,并研究了常见的青年参与策略。
PATC3H 联盟通过里程碑过渡机制支持八项研究。该联盟包括在七个国家开展的 AYA HIV 研究项目 - 巴西、肯尼亚、莫桑比克、尼日利亚、南非、乌干达和赞比亚。NIH 申请要求包括与利益相关者的早期协商的过渡里程碑。NIH 对八项研究提出的过渡里程碑要求包括与卫生和政策利益相关者的早期协商、试点干预数据以及来自国家政府利益相关者的承诺。所有研究都为 AYA 参与提供了多种途径,包括 AYA 咨询委员会和青年主导的研究项目。
数据表明,要求达到过渡到最后阶段的里程碑可能有助于卫生和政策利益相关者的参与,并加强监管协议的形成性评估。这些数据对在低收入和中等收入国家设计参与式研究具有影响。