Optimizing implementation of long-acting, injectable Cabotegravir for HIV prevention among adolescents and young adults in Zambia

优化长效注射卡博特韦的实施，以预防赞比亚青少年和年轻人的艾滋病毒

基本信息

批准号：
10548371
负责人：
Laura Beres
金额：
$ 16.33万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-01 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10548371
关键词：
AIDS prevention Adherence Adolescent and Young Adult Affective Africa South of the Sahara Area Characteristics Clinical Trials Cognitive Collaborations Competence Contraceptive methods Country Data Data Collection Development Disease Educational Status Educational workshop Effectiveness Ensure Exploration Preparation Implementation and Sustainment Face Formulation Future Goals Guidelines HIV HIV Infections HIV risk Health Health Personnel Health care facility Health system Heterogeneity Incidence Individual Infectious Diseases Research Injectable Institution International Internet Intervention Knowledge Low income Measures Mentored Research Scientist Development Award Mentors Methods Oral Outcome Perception Policies Population Prevalence Prevention Process Protocols documentation Recommendation Reporting Research Research Personnel Research Training Resource-limited setting Risk Assessment Sampling Scientist Specific qualifier value Stratification Subgroup Technology Testing Time Training Woman Zambia aged base career career development cis-female cis-male evidence base experience experimental study health care delivery high risk high risk population implementation evaluation implementation facilitation implementation science implementation strategy improved innovation men novel population based pre-exposure prophylaxis preference prevent preventive intervention programs recruit research and development skills success sustainability framework transgender women uptake

项目摘要

This K01 Mentored Research Scientist Development Award application will facilitate Dr. Laura Beres’ career development as a leading, productive, independent researcher conducting innovative implementation science to maximize the real-world impact of HIV prevention interventions among high-risk populations in low-resource settings. The proposed training plan and research implementation in Zambia will allow Dr. Beres to meet her training objectives, developing the critical knowledge, skills, and competencies required to transition into an independent researcher. She will: 1. Gain expertise in pre-exposure prophylaxis (PrEP) and prevention interventions, 2. Develop skills in evidence-based, stakeholder-informed implementation strategy specification to optimize population-level impact of novel interventions, 3. Develop statistical expertise in discrete choice experiments and latent class analysis, 4. Establish capacity in internet-based recruitment and data collection in a low-resource setting, 5. Understand and measure developmental differences, including cognitive and affective development, among adolescents and young adults and their associations with HIV prevention. Dr. Beres’ mentoring team will support her successful achievement of her training, research, and career development goals. Dr. Chris Beyrer, her primary mentor, is an international expert in HIV prevention. She has five co-mentors: Dr. Sinead Delany-Moretlwe, an expert in LAI CAB as protocol chair of HPTN 084; Dr. Sheree Schwartz, a leading HIV implementation scientist with latent class analysis expertise; Dr. John F.P. Bridges, an international expert in discrete choice experiments; Dr. Julie Denison, an expert in adolescent and young adult development and HIV in Zambia; and Dr. Izukanji Sikazwe, a leading HIV researcher and Chief Executive Officer of Dr. Beres’ collaborating institution, the Centre for Infectious Disease Research in Zambia (CIDRZ). Her Scientific Advisor Dr. Smisha Agarwal is an expert in internet-based research in low-income settings. LAI CAB PrEP was found superior to daily oral PrEP in clinical trials and received US FDA approval in December 2021 with international regulatory approvals pending. LAI CAB PrEP has the potential to prevent HIV among those who experience barriers to effective oral PrEP use, including adolescents and young adults (AYA) in sub-Saharan Africa who remain at highest risk of HIV incidence. The proposed K01 research utilizes implementation science to establish evidence needed to optimize LAI CAB PrEP implementation for AYA in Zambia, minimizing the time from proven LAI CAB PrEP efficacy to population impact: Aim 1. Assess the fidelity and sustainability of implementation strategies for two related interventions: oral PrEP and injectable contraception, to inform LAI CAB implementation using participatory process mapping; Aim 2. Identify preferences for LAI CAB implementation and heterogeneity among AYA and healthcare workers using discrete choice experiments and latent class analysis with internet-based recruitment; Aim 3. Specify LAI CAB implementation strategies to support LAI CAB use and persistence. A future R01 will evaluate implementation.

此次 K01 指导研究科学家发展奖申请将促进 Laura Beres 博士的职业生涯发展成为领先的、富有成效的、独立的研究人员，进行创新的实施科学最大限度地发挥艾滋病毒预防干预措施对资源匮乏的高危人群的现实影响拟议的赞比亚培训计划和研究实施将使贝雷斯博士能够与她见面。培训目标，培养过渡到成为合格人员所需的关键知识、技能和能力她将： 1. 获得暴露前预防 (PrEP) 和预防方面的专业知识。干预措施，2. 培养基于证据、利益相关者知情的实施战略规范的技能优化新干预措施对人口层面的影响，3. 发展离散选择方面的统计专业知识实验和潜在类别分析，4. 建立基于互联网的招聘和数据收集能力 5. 理解并衡量发育差异，包括认知和认知差异青少年和年轻人的情感发展及其与艾滋病毒预防的关系。贝雷斯的指导团队将支持她在培训、研究和职业生涯中取得成功她的主要导师 Chris Beyrer 博士是艾滋病预防领域的国际专家。五位联合导师：Sinead Delany-Moretlwe 博士，LAI CAB 专家，HPTN 084 协议主席 Sheree 博士； Schwartz 是一位领先的 HIV 实施科学家，拥有潜在类别分析专业知识；John F.P Bridges 博士国际离散选择实验专家 Julie Denison 博士，青少年研究专家赞比亚的发展和艾滋病毒；以及首席艾滋病毒研究员兼首席执行官 Izukanji Sikazwe 博士 Beres 博士的合作机构赞比亚传染病研究中心 (CIDRZ) 的官员。她的科学顾问 Smisha Agarwal 博士是低收入环境中互联网研究的专家。临床试验发现 CAB PrEP 优于每日口服 PrEP，并于 12 月获得美国 FDA 批准 2021 年，LAI CAB PrEP 有望预防艾滋病毒。那些在有效口服 PrEP 使用方面遇到障碍的人，包括青少年和年轻人 (AYA) 撒哈拉以南非洲地区的艾滋病毒发病风险仍然最高。拟议的 K01 研究利用了这一点。实施科学，以建立优化 AYA 的 LAI CAB PrEP 实施所需的证据赞比亚，最大限度地缩短从经过验证的 LAI CAB PrEP 功效到对人群产生影响的时间：目标 1. 评估两种相关干预措施（口服 PrEP 和注射）策略实施的保真度和可持续性避孕，利用参与性流程图为 LAI CAB 的实施提供信息；目标 2。使用离散的 AYA 和医护人员对 LAI CAB 实施的偏好以及异质性基于互联网的招聘的选择实验和潜在类别分析；目标 3. 指定 LAI CAB 支持 LAI CAB 使用和持久性的实施策略未来的 R01 将评估实施情况。