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

基本信息

批准号：
9910448
负责人：
Susan Buchbinder
金额：
$ 48.56万
依托单位：
PUBLIC HEALTH FOUNDATION ENTERPRISES
依托单位国家：
美国
项目类别：
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/9910448
关键词：
3-Dimensional AIDS prevention Accounting Address Adherence Affect Age Area Behavioral Blood California Clinic Clinic Visits Clinical Clinical Services Collection Color Cost Analysis Cost Measures Country County Diphosphates Effectiveness Enrollment Ensure Feedback Focus Groups Funding HIV HIV Infections HIV diagnosis Health Healthcare Systems Incidence Infection Insurance Insurance Carriers Intervention Laboratories Latino Measures Medical Methods Modeling Modification Motivation Outcome Measure Participant Patients Pattern Performance 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 effectiveness evaluation experience improved incremental cost-effectiveness infection risk innovation interest intervention cost mHealth medical appointment men who have sex with men men&apos 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

项目摘要

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.

项目概要/摘要男男性行为者 (MSM) 是美国受艾滋病毒影响最严重的人群，占所有新艾滋病毒诊断的三分之二以上。暴露前预防 (PrEP) 已被证明 MSM 中的艾滋病毒预防效果很高，但停药率很高，而且成为实施 PrEP 的主要挑战。药房主导的 PrEP 交付模式，结合借助基于移动应用程序的 PrEP 支持，可以解决开始和维持 PrEP 时遇到的许多挑战，也大大减轻了医疗系统的负担，因为目前每季度就诊的要求每年将需要 440 万人次额外就诊。基于信息-动机-行为技能模型，我们开发了 PrEP-3D 干预，这是一款集成的移动应用程序，可提高 PrEP 的采用率 MSM 的持续性，其主要特征包括 1) 性风险评分，其中考虑了性行为的影响 PrEP 使用的风险； 2) 综合性行为和服药日记，提供 PrEP 水平信息基于依从模式的保护，并通过服药提醒和激励徽章进行增强； 3）一个交互式双向消息支持系统，具有自动签入功能，可快速解决问题副作用或保险问题等问题； 4) 与在线药房主导的 PrEP 计划整合协调实验室测试和药物补充，提供药物支持，并解决保险/费用问题问题。该集成 PrEP-3D 平台的有效性将与基于临床的 PrEP 进行比较在高度多元化的旧金山湾区 (SFBA) 为 MSM 发起 PrEP 提供服务在加州新增艾滋病毒确诊人数中排名第二。在目标 1 中，PrEP-3D 将通过以下方式进行完善：与 32-40 MSM 进行迭代焦点小组，然后在为期 3 个月的技术试点中优化干预措施 30 名男男性行为者中，其中 10 人会讲西班牙语。在目标 2 中，我们将进行随机对照试验评估 PrEP-3D 在改善 SFBA 中 PrEP 启动和持久性方面的有效性。在这次审判中，我们将招募 150 名有兴趣开始 PrEP 的高危 MSM，他们将按 2:1 随机分配至 PrEP-3D (N=100) 或护理控制条件标准（基于诊所的 PrEP 实施）（N=50）并评估替诺福韦二磷酸盐（TFV- DP）在 3、6、9 和 12 个月时干血斑中的水平作为我们的主要结果指标。在目标 3 中，我们将评估 PrEP-3D 与基于临床的 PrEP 实施的成本和成本效益。为了确保将这些 SFBA 中受艾滋病毒影响尤为严重，因此我们将招收至少 50% 的黑人和拉丁裔学生以及 50% 的黑人和拉丁裔学生 35 岁。这些研究将检验以下假设：PrEP-3D 干预将比临床干预更有效基于 PrEP 的交付可以增加 MSM 中 PrEP 的吸收和持久性，并且可以作为一种可扩展的方法扩大 PrEP 服务和支持全国弱势群体的模式。