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

• 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
• 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

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.

这份K01指导研究科学家发展奖的申请将促进Laura Beres博士的职业生涯 作为领先的、富有成效的独立研究人员进行创新实施科学的发展 在低资源地区的高危人群中最大限度地发挥艾滋病毒预防干预措施的实际影响 设置。拟议的培训计划和在赞比亚的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 独立研究人员。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.发展以证据为基础、利益相关者知情的实施战略规范的技能 为了优化新干预措施对人口水平的影响，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.建立网上招聘和数据收集的能力 低资源环境，5.了解和测量发展差异，包括认知和 青少年和青壮年的情感发展及其与艾滋病毒预防的关系。Dr。 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的成功 发展目标。她的主要导师克里斯·拜勒博士是艾滋病毒预防方面的国际专家。她有 五位共同导师：Sinead Delany-Moretlwe博士，LAI CAB专家，HPTN 084礼宾主席；Sheree博士 施瓦茨，领先的艾滋病毒实施科学家，具有潜在的类别分析专业知识；约翰·F·P·布里奇斯博士， 国际离散选择实验专家；朱莉·丹尼森博士，青少年和青壮年专家 赞比亚的发展和艾滋病毒；以及领先的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。 她的科学顾问斯米沙·阿加瓦尔博士是低收入群体互联网研究方面的专家。赖 CAB PrEP在临床试验中被发现优于每日口服PrEP，并于去年12月获得美国FDA的批准 2021年，国际监管部门正在等待批准。LAI CAB PrEP具有预防艾滋病毒的潜力 那些在有效使用PrEP方面遇到障碍的人，包括青少年和年轻人(Aya) 仍然处于艾滋病毒发病率最高风险的撒哈拉以南非洲地区。拟议的K01研究利用 实施科学为优化Aya的LAI CAB PrEP实施提供必要的证据 赞比亚，最大限度地减少从证明LAI CAB PrEP效果到人口影响的时间：目标1.评估 两种相关干预措施实施战略的保真度和可持续性：口服PrEP和注射 避孕，告知LAI CAB的实施情况，使用参与性过程图；目标2.确定 对LAI CAB实施的偏好以及Aya和医护人员之间的异质性 网上招聘的选择实验和潜在阶级分析；目标3.具体说明LAI CAB 实施战略，以支持LAI CAB的使用和持久性。未来的R01将评估实施情况。