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 马里兰州巴尔的摩的艾滋病毒发病率是美国最高的，其中男男性行为者 (MSM) 随着我们进入联合国联合规划署的“95-95-95”时代，我们承受着不成比例的疾病负担。 艾滋病毒/艾滋病（联合国艾滋病规划署）快速通道目标，研究扩展预防工具箱的创新方法 最近批准了用于 HIV 暴露前预防 (PrEP) 的长效 (LA) 卡博特韦 (CAB)。 FDA 基于证明其优于富马酸替诺福韦二吡呋酯 (TDF)/恩曲他滨的数据 (FTC)，尤其是通过增加 PrEP 的使用/摄取，LA PrEP 可能有助于克服口服 PrEP 的关键挑战。 此外，许多研究表明，社会和结构方面的影响。 健康的决定因素 (SSDoH)，例如贫困、种族主义、机会、同性恋和歧视， 个人和社区层面的因素，例如耻辱感、知识和对 PrEP 的看法，影响了 PrEP 的获取 迄今为止的研究已经探讨了 LA PrEP 作为一种方法的可接受性。 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 关于高风险 MSM 社区中 LA PrEP 的看法和可接受性及其与性网络的关系 结构（例如，一个人的联系人的看法和行为如何影响一个人对洛杉矶的看法 此外，即使在那些口服 PrEP 的人中，人们对其知识、可接受性和认知也知之甚少。 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 与基于 TDF 的方案的偏好 TDF/FTC 2-1-1（按需）PrEP，直到 2021 年才纳入 CDC 指南。申请人 拟议的研究，扩展预防工具箱：探索长效的可接受性和影响 巴尔的摩 MSM 中的注射 PrEP：一项试点研究将解决这一差距 本研究将收集以下方面的数据。 巴尔的摩 MSM 中社区对 PrEP 选择的偏好，并使用此信息来通知消息传递 和支持机制，以及生成行为和网络数据来为流行病学模型提供信息 减少 PrEP 障碍的政策 这将通过以下目标来实现： 目标 1：使用 来自家长研究焦点小组访谈的主题分析，以完善横断面调查，包括 用于 PrEP 偏好的 DCE 模块，具有随机分配属性（即成本、副作用、有效性、 每个 PrEP 选择集中的保险范围等） 目标 2：描述巴尔的摩的 MSM 性网络。 (N=500) 以确定易感因素、促成因素和感知需求因素对 PrEP 使用/吸收的影响。 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 PrEP 的使用呈正相关，H2：PrEP DCE 中确定的偏好与性网络伴侣偏好呈正相关。 创新研究建立在进行焦点小组和优质数据的数月前期工作的基础上 它为未来研究评估 LA PrEP 的作用奠定了基础。 MSM 社区实施知情的 PrEP 策略。