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.

K 01指导研究科学家发展奖申请将促进Laura Beres博士的职业生涯 发展作为一个领先的，多产的，独立的研究人员进行创新的实施科学 最大限度地扩大艾滋病毒预防干预措施在低资源地区高危人群中的实际影响， 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会面， 培训目标，发展关键知识，技能和过渡到一个 独立研究员。她会：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 优化新型干预措施的人群水平影响，3.发展离散选择的统计专业知识 实验和潜在类分析，4。* 建立网上征聘和数据收集能力， 低资源环境，5.理解和衡量发展差异，包括认知和 青少年和年轻人的情感发展及其与艾滋病毒预防的关系。博士 Beres的指导团队将支持她在培训，研究和职业生涯中取得成功 发展目标她的主要导师Chris Beyrer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方案主席; Sheree博士 Schwartz博士是一位具有潜在类别分析专业知识的领先的艾滋病毒实施科学家; John F. P. Bridges博士是一位 独立选择实验的国际专家;朱莉·丹尼森博士，青少年和年轻人的专家 艾滋病毒问题的主要研究人员和首席执行官Izukanji Sikazwe博士 Beres博士的合作机构赞比亚传染病研究中心官员。 她的科学顾问Smisha Agarwal博士是低收入环境中基于互联网的研究专家。赖 在临床试验中发现CAB PrEP上级每日口服PrEP，并于12月获得美国FDA批准 2021年，国际监管机构正在等待批准。LAI CAB PrEP有可能预防艾滋病毒， 那些经历有效口服PrEP使用障碍的人，包括青少年和年轻人（AYA）， 撒哈拉以南非洲仍然是艾滋病毒感染率最高地区。建议的K 01研究利用 实施科学，以建立优化AYA LAI CAB PrEP实施所需的证据， 赞比亚，最大限度地减少从经证实的LAI CAB PrEP疗效到人群影响的时间：目标1。评估 两种相关干预措施的实施战略的忠实性和可持续性：口服PrEP和注射 避孕，使用参与性过程绘图为LAI CAB的实施提供信息;目标2。识别 LAI CAB实施的偏好以及AYA和医疗保健工作者使用离散 选择实验和潜在类分析与基于互联网的招聘;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R 01将评估实施情况。