PrEP-3D: An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM

PrEP-3D：综合药房数字日记和交付策略，以增加 MSM 中 PrEP 的使用

• 批准号: 10386808
• 负责人: Susan Buchbinder
• 金额: $ 49.53万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-08 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10386808
• 关键词: 3-Dimensional; AIDS prevention; Accounting; Address; Adherence; Affect; Age; Area; Behavioral; Black race; Blood; California; Clinic; Clinic Visits; Clinical; Clinical Services; Collection; Cost Analysis; Cost Measures; Country; County; Diphosphates; Effectiveness; Enrollment; Ensure; Feedback; Focus Groups; Funding; HIV; HIV Infections; HIV diagnosis; Healthcare Systems; Incidence; Infection; Insurance; Insurance Carriers; Intervention; Laboratories; Latino; Measures; Medical; Methods; Modeling; Modification; Motivation; Outcome Measure; Participant; Patients; Pattern; Performance; Persons; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Pilot Projects; Population; Population Heterogeneity; Populations at Risk; Prevalence; Provider; Randomized; Randomized Controlled Trials; Resolution; Risk; San Francisco; Services; Spottings; Support System; System; Tenofovir; Testing; Triage; United States; United States National Institutes of Health; Visit; Vulnerable Populations; Youth; arm; base; cost; cost effective; cost effectiveness; cost estimate; cost-effectiveness ratio; diaries; digital; digital health; effectiveness evaluation; experience; improved; incremental cost-effectiveness; infection risk; innovation; interest; intervention cost; mHealth; medical appointment; men of color; men who have sex with men; men' s group; mobile application; mobile computing; novel; pill; pre-exposure prophylaxis; preference; prevent; primary outcome; programs; side effect; skills; standard of care; tool; treatment arm; uptake; usability; young men who have sex with men

Project Summary/Abstract Men who have sex with men (MSM) are the population most affected by HIV in the United States, accounting for over two-thirds of all new HIV diagnoses. Pre-exposure prophylaxis (PrEP) has demonstrated high levels of efficacy for HIV prevention among MSM, however, discontinuation rates are high and are emerging as the primary challenge in implementing PrEP. A pharmacy-led model of PrEP delivery, combined with mobile app-based PrEP support, could address many of the challenges with starting and staying on PrEP, and also greatly reduce burden on the medical system, as the current requirement for quarterly clinic visits would require 4.4 million additional medical visits annually. Based on the Information-Motivation-Behavioral Skills model, we have developed the PrEP-3D intervention, an integrated mobile app to increase PrEP uptake and persistence among MSM, with key features including 1) a sexual risk score that incorporates the impact of PrEP use on risk; 2) an integrated sexual and pill-taking diary that provides information on levels of PrEP protection based on adherence patterns, augmented with pill reminders and motivational badges; 3) an interactive bi-directional messaging support system with automated check-ins to allow rapid resolution of issues such as side effects or insurance issues; and 4) integration with an online pharmacy-led PrEP program that coordinates lab tests and medication refills, provides medication support, and addresses insurance/cost issues. The effectiveness of this integrated PrEP-3D platform will be compared with clinic-based PrEP provision among MSM initiating PrEP throughout the San Francisco Bay Area (SFBA), a highly diverse region ranking 2nd in the number of new HIV diagnoses in California. In aim 1, PrEP-3D will be refined through iterative focus groups with 32-40 MSM, followed by optimization of the intervention in a 3-month technical pilot among 30 MSM, 10 of whom will be Spanish-speaking. In aim 2, we will conduct a randomized controlled trial to evaluate the effectiveness of PrEP-3D in improving PrEP initiation and persistence in the SFBA. In this trial, we will enroll 150 at-risk MSM interested in starting PrEP who will be randomized 2:1 to PrEP-3D (N=100) or a standard of care control condition (clinic-based PrEP delivery) (N=50) and assess tenofovir-diphosphate (TFV- DP) levels in dried blood spots at 3, 6, 9, and 12 months as our primary outcome measure. In aim 3, we will assess cost and cost-effectiveness of PrEP-3D vs. clinic-based PrEP delivery. To ensure inclusion of those disproportionately impacted by HIV in the SFBA, we will enroll at least 50% Black and Latino and 50% under age 35. These studies will test the hypotheses that the PrEP-3D intervention will be more effective than clinic- based PrEP delivery in increasing PrEP uptake and persistence among MSM, and can serve as a scalable model for expanding PrEP services and support to vulnerable populations nationwide.

项目摘要/摘要 与男性发生性关系（MSM）的男人是美国受艾滋病毒影响最大的人群， 占所有新艾滋病毒诊断的三分之二以上。暴露前预防（PREP）已证明 但是 成为实施PREP的主要挑战。由药房主导的准备交付模型，合并 有了基于移动应用的PREP支持，可以解决启动和保持准备的许多挑战， 并且也大大减轻了医疗系统的负担，因为目前对季度诊所的要求 每年需要440万次额外的医疗访问。基于信息动机行为 技能模型，我们已经开发了Prep-3D干预措施，这是一种集成的移动应用程序，以增加吸收准备 和MSM之间的持久性，关键特征包括1）性风险评分，其中包含了 准备风险使用； 2）综合性和药丸日记，提供有关准备水平的信息 基于依从性模式的保护，以药丸提醒和动机徽章增强； 3） 交互式双向消息支持系统具有自动校验，以便快速解决 副作用或保险问题等问题； 4）与在线药房主导的预备计划集成 这协调实验室测试和补充药物，提供药物支持，并解决保险/费用 问题。该集成的Prep-3D平台的有效性将与基于诊所的Prep进行比较 在整个旧金山湾地区（SFBA）的MSM中，在一个高度多样化的地区启动准备 在加利福尼亚州的新艾滋病毒诊断数量中排名第二。在AIM 1中，Prep-3D将通过 具有32-40 msm的迭代焦点小组，然后在3个月的技术飞行中优化干预措施 在30个MSM中，其中10个将说西班牙语。在AIM 2中，我们将进行随机对照试验 评估PREP-3D在改善SFBA的PREP启动和持久性方面的有效性。在这个试验中， 我们将注册150个有兴趣启动Prep的高风险MSM谁将被随机分为2：1到Prep-3d（n = 100）或A 护理标准控制条件（基于临床的PREP递送）（n = 50）并评估替诺福韦 - 磷酸盐（TFV- DP）在3、6、9和12个月的干燥血斑中的水平是我们的主要结局指标。在AIM 3中，我们将 评估Prep-3D与基于诊所的Prep交付的成本和成本效益。确保包含这些 在SFBA中受艾滋病毒的影响不成比例，我们将至少注册50％的黑人和拉丁美洲人，而50％以下 年龄35岁。这些研究将检验以下假设，即Prep-3D干预将比临床更有效 基于MSM之间的准备摄取和持久性的基于预备递送，并且可以作为可扩展的 扩大准备服务和支持全国脆弱人群的模型。