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

项目摘要/摘要 男男性行为者(MSM)是美国受艾滋病毒影响最大的人群， 占所有新的艾滋病毒诊断病例的三分之二以上。暴露前预防(PrEP)已经证明 在男男性接触者中预防艾滋病毒的有效性很高，然而，戒毒率很高，而且 成为实施PrEP的主要挑战。药房主导的PrEP交付模式，结合 通过基于移动应用的PrEP支持，可以解决启动和保持PrEP的许多挑战， 也大大减轻了医疗系统的负担，因为目前要求每季度就诊一次 每年将需要额外的440万次就诊。基于信息-动机-行为的研究 技能模型，我们开发了PrEP-3D干预，这是一款集成的移动应用程序，可以增加PrEP的摄入量 和在MSM中的持久性，主要特征包括1)性风险评分，包括 为风险使用做好准备；2)提供有关PrEP水平的综合性和服药日记 基于遵守模式的保护，并通过避孕药提醒和激励徽章来增强；3)以及 具有自动签到功能的交互式双向消息传递支持系统，可快速解决 副作用或保险问题等问题；以及4)与在线药房主导的PrEP计划的集成 协调实验室测试和药物补充，提供药物支持，并解决保险/成本问题 问题。该集成PrEP-3D平台的有效性将与基于临床的PrEP进行比较 在高度多样化的旧金山湾区(SFBA)启动PrEP的MSM中提供服务 在加利福尼亚州新诊断的艾滋病毒病例中排名第二。在AIM 1中，PrEP-3D将通过 与32-40名MSM组成迭代焦点小组，然后在为期3个月的技术试点中优化干预措施 在30名男男性接触者中，其中10人将会说西班牙语。在目标2中，我们将进行随机对照试验 目的：评价PrEP-3D在改善SFBA内PrEP起始性和持久性方面的效果。在这场审判中， 我们将招募150名对启动PrEP感兴趣的高危MSM，他们将被随机分为2：1到PrEP-3D(N=100)或 护理控制标准条件(基于临床的PrEP交付)(N=50)和评估替诺福韦-二磷酸(TFV- 3、6、9和12个月时干血斑点的DP)水平作为我们的主要预后指标。在《目标3》中，我们将 评估PrEP-3D与基于临床的PrEP交付的成本和成本效益。以确保将这些 在SFBA中，受艾滋病毒影响不成比例，我们将招收至少50%的黑人和拉丁裔，50%以下 35岁。这些研究将检验PrEP-3D介入将比临床更有效的假设- 基于PrEP的交付可提高MSM对PrEP的摄取率和持久性，并可作为可扩展的 扩大PrEP服务和向全国弱势人群提供支持的模式。

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.