Extending the Prevention Toolbox: Exploring the Acceptability and Impact of Long-acting Injectable PrEP among MSM in Baltimore: A Pilot Study

扩展预防工具箱：探索巴尔的摩 MSM 中长效注射 PrEP 的可接受性和影响：一项试点研究

• 批准号: 10838855
• 负责人: Amit Mickey Dhir
• 金额: $ 4.77万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-11 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10838855
• 关键词: Adherence; Area; Baltimore; Behavior; Characteristics; Cities; Combination Medication; Communities; Contracts; Cross-Sectional Studies; Data; Data Analyses; Decision Making; Diagnosis; Diffusion; Discrimination; Effectiveness; Epidemic; FDA approved; Focus Groups; Foundations; Fumarates; Future; Group Interviews; Guidelines; HIV; HIV Infections; HIV/AIDS; Health system; Incidence; Individual; Infection; Injectable; Insurance Coverage; Intervention; Joints; Knowledge; Market Research; Methodology; Methods; Modeling; National Institute of Allergy and Infectious Disease; Oral; Parents; Participant; Perception; Pharmaceutical Preparations; Phase; Pilot Projects; Policies; Population; Positioning Attribute; Poverty; Prevention; Prevention strategy; Process; Random Allocation; Regimen; Reporting; Research; Respondent; Risk; Role; Self Administration; Series; Shapes; Strategic Planning; Structure; Tenofovir; United States; Viral; Vulnerable Populations; Work; burden of illness; care systems; community-level factor; cost; emtricitabine; epidemiological model; experimental study; health equity promotion; high risk men; homonegativity; innovation; men who have sex with men; novel; novel strategies; outcome disparities; pandemic disease; pre-exposure prophylaxis; preference; prevent; programs; racism; side effect; social determinants; social stigma; structural health determinants; therapy development; treatment as prevention; uptake

PROPOSAL SUMMARY The incidence of HIV in Baltimore, MD is among the highest in the US, with men who have sex with men (MSM) bearing a disproportionate burden of the disease. As we enter the “95-95-95” era of the Joint UN Program on HIV/AIDS (UNAIDS) Fast Track targets, research into innovative approaches that extend the prevention toolbox is needed. Long-acting (LA) cabotegravir (CAB) for HIV pre-exposure prophylaxis (PrEP) was recently approved by the FDA based on data that demonstrated superiority to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC). LA PrEP may help overcome key challenges of oral PrEP by increasing PrEP use/uptake, particularly among key populations, such as MSM. Furthermore, much research has shown that social and structural determinants of health (SSDoH), such as poverty, racism, access, homonegativity and discrimination and individual and community-level factors, such as stigma, knowledge, and perception towards PrEP shape access and uptake of PrEP among MSM individuals. Studies to date have explored the acceptability of LA PrEP as a hypothetical option among MSM; however, since the FDA approval of LA CAB in December 2021, little is known about perceptions and acceptability of LA PrEP in high-risk MSM communities and its relation to sexual network structures (e.g., how do the perceptions and behaviors of one’s contacts influence one’s own perception of LA PrEP). Further, even among those on oral PrEP, little is known about the knowledge, acceptability, and preference of daily tenofovir alafenamide (TAF) vs. TDF-based regimens and further still, daily oral PrEP vs. TDF/FTC 2-1-1 (on-demand) PrEP, which was not included in CDC guidelines until 2021. The applicants proposed study, Extending the Prevention Toolbox: Exploring the Acceptability and Impact of Long-acting Injectable PrEP among MSM in Baltimore: A Pilot Study will address this gap. This study will gather data on community preferences for PrEP choices among MSM in Baltimore and use this information to inform messaging and support mechanisms, as well as generate data on behaviors and networks to inform epidemiological models and policies to reduce barriers to PrEP. This will be accomplished through the following aims: Aim 1: To use thematic analysis from the parent study focus group interviews, to refine a cross-sectional survey including a DCE module for PrEP preferences with random allocation of attributes (i.e., cost, side-effects, effectiveness, insurance coverage etc.) within each PrEP choice set. Aim 2: To characterize MSM sexual networks in Baltimore (N=500) to determine the impact of predisposing, enabling, and perceived need factors on PrEP use/uptake. Aim3: To evaluate how sexual network characteristics impacts PrEP use/uptake and preferences among MSM; H1: The use/uptake of PrEP is positively associated with PrEP use within sexual networks and H2: PrEP preferences, as determined in the DCE are positively associated with sexual network partner preferences. This innovative study builds on over many months of preliminary work of conducting focus groups and qual data analysis for the parent study. It establishes a foundation for future studies to evaluate the role of LA PrEP in MSM communities to implement an informed PrEP strategy.

提案摘要 艾滋病毒的发病率在巴尔的摩，MD是在美国最高的，与男男性行为（MSM） 承受着不成比例的疾病负担。随着我们进入联合国联合方案的“95-95-95”时代， 艾滋病毒/艾滋病（艾滋病规划署）快速通道目标，研究扩大预防工具箱的创新办法 是必要的。用于HIV暴露前预防（PrEP）的长效（LA）cabotegravir（CAB）最近获得批准 FDA基于证明优于富马酸替诺福韦酯（TDF）/恩曲他滨的数据 （FTC）. LA PrEP可能有助于通过增加PrEP的使用/摄取来克服口服PrEP的关键挑战，特别是 在关键人群中，如MSM。此外，许多研究表明，社会和结构 健康的决定因素，如贫困、种族主义、获取、同性恋否定和歧视， 个人和社区层面的因素，例如耻辱、知识和对PrEP的看法，影响了获得机会 以及MSM人群中PrEP的摄入量。迄今为止的研究已经探索了LA PrEP作为 MSM中的假设选择;然而，自FDA于2021年12月批准LA CAB以来，人们知之甚少 关于LA PrEP在高风险MSM社区的看法和可接受性及其与性网络的关系 结构（例如，一个人的接触的感知和行为如何影响一个人对LA的感知 PrEP）。此外，即使在口服PrEP的人中，对知识，可接受性和 每日替诺福韦艾拉酚胺（TAF）与基于TDF的方案的偏好，以及每日口服PrEP与 TDF/FTC 2-1-1（按需）PrEP，直到2021年才被纳入CDC指南。申请人 拟议的研究，扩大预防疟疾：探索长效避孕药的可接受性和影响 巴尔的摩的男男性接触者中注射PrEP：一项试点研究将解决这一差距。本研究将收集以下数据： 巴尔的摩MSM中PrEP选择的社区偏好，并使用此信息通知消息传递 和支持机制，以及生成行为和网络数据，为流行病学模型提供信息 减少PrEP障碍的政策。这将通过以下目标实现：目标1：使用 主题分析从家长研究焦点小组访谈，以完善一个横断面调查，包括 用于PrEP偏好的DCE模块，随机分配属性（即，成本，副作用，有效性， 保险范围等）在每个PrEP选择集内。目的2：描述巴尔的摩MSM性网络的特征 （N=500），以确定易感性，使能性和感知需求因素对PrEP使用/摄取的影响。 目标3：评估性网络特征如何影响MSM中PrEP的使用/吸收和偏好; H1：PrEP的使用/摄取与性网络中的PrEP使用呈正相关，H2：PrEP 在DCE中确定的偏好与性网络伴侣偏好正相关。这 创新性研究建立在进行焦点小组和质量数据的数月初步工作的基础上 母研究的分析。它为未来的研究奠定了基础，以评估LA PrEP在以下方面的作用： MSM社区实施知情的PrEP战略。