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: 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
• 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' 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.

项目总结/摘要 在美国，男男性行为者（MSM）是受艾滋病毒影响最严重的人群， 占所有艾滋病毒新诊断病例的三分之二以上。暴露前预防（PrEP）已经证明 艾滋病毒预防在男男性行为者中的有效性较高，但是，停药率很高， 正在成为实施PrEP的主要挑战。一个以药房为主导的PrEP交付模式， 有了基于移动的应用程序的PrEP支持，可以解决开始和保持PrEP的许多挑战， 也大大减轻了医疗系统的负担，因为目前需要每季度进行一次诊所访问， 每年需要增加440万次医疗访问。基于信息-动机-行为 技能模型，我们已经开发了PrEP-3D干预，这是一个集成的移动的应用程序，以增加PrEP的吸收 和持续性的男男性接触者，其主要特征包括：1）性风险评分，包括以下因素的影响： PrEP使用风险; 2）综合性和服药日记，提供PrEP水平的信息 基于坚持模式的保护，增加了药丸提醒和激励徽章; 3） 交互式双向消息传送支持系统，具有自动登记， 问题，如副作用或保险问题;以及4）与在线药店主导的PrEP计划整合 协调实验室检查和药物补充，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 在旧金山弗朗西斯科湾区（SFBA），一个高度多样化的地区， 在加州新诊断的艾滋病患者中排名第二。在目标1中，PrEP-3D将通过 32-40名男男性接触者的迭代焦点小组，随后在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人将讲西班牙语。在目标2中，我们将进行一项随机对照试验， 评价PrEP-3D在改善SFBA中PrEP启动和持续性方面的有效性。在这次审判中， 我们将招募150名有兴趣开始PrEP的高危MSM，他们将以2：1的比例随机接受PrEP-3D（N=100）或 护理标准控制条件（基于临床PrEP递送）（N=50）并评估替诺福韦二磷酸盐（TFV- 在3、6、9和12个月时干血斑中的DP）水平作为我们的主要结果测量。在目标3中，我们 评估PrEP-3D与基于诊所的PrEP交付的成本和成本效益。为了确保将这些 在SFBA受艾滋病毒影响不成比例的情况下，我们将招收至少50%的黑人和拉丁美洲人以及50%的 三十五岁。这些研究将测试PrEP-3D干预比临床更有效的假设。 基于PrEP的交付在增加PrEP吸收和MSM之间的持久性，并可以作为一个可扩展的 扩大PrEP服务和支持全国弱势群体的模式。