RP3 PrEP Choice

RP3 PrEP 选择

• 批准号: 10595903
• 负责人: Lisa B Hightow-Weidman
• 金额: $ 6.14万
• 依托单位: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-25 至 2029-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10595903
• 关键词: AIDS prevention; Accounting; Address; Adherence; Adolescent; Adolescent Medicine Trials Network; Adoption; Age; Biometry; Bisexual; Blood; California; Caring; Cellular Phone; Collection; Communication; Conflict (Psychology); Cost Measures; Country; Crossover Design; Diphosphates; Dose; Dryness; Effectiveness of Interventions; Enrollment; Ensure; Ethnic Origin; Event; Evidence based intervention; FDA approved; Feedback; Focus Groups; Fumarates; Gays; Geography; HIV; HIV Infections; HIV diagnosis; HIV/AIDS; Individual; Infection; Injectable; Injections; Intervention; Leadership; Link; Measures; Mediator; Modality; Modeling; Modification; Oral; Pamphlets; Participant; Patients; Performance; Persons; Pharmaceutical Preparations; Pilot Projects; Population; Population Heterogeneity; Race; Randomized; Randomized, Controlled Trials; Regimen; Resources; Self Efficacy; Site; Southern Africa; Spottings; System; Target Populations; Tenofovir; Testing; Text Messaging; Time; United States; Waiting Lists; Work; Youth; aged; arm; cost; cost effective; cost effectiveness; cost estimate; cost-effectiveness ratio; design; effectiveness evaluation; efficacy evaluation; empowerment; emtricitabine; evidence base; follow-up; improved; incremental cost-effectiveness; innovation; intervention cost; mHealth; men who have sex with men; mobile application; mobile computing; multidisciplinary; pill; pre-exposure prophylaxis; preference; primary outcome; provider communication; recruit; support tools; tool; two way texting; uptake; usability; web site; young adult; young woman

PROJECT SUMMARY Young persons, aged 13-24 years, accounted for 21% of new infections in the United States in 2018, and 81% of these occurred in young gay, bisexual, and other men who have sex with men (YGBMSM). Currently, there are 4 different regimens of pre-exposure prophylaxis (PrEP) available for YGBMSM: 1) daily tenofovir disoproxil fumarate co-formulated with emtricitabine (TDF/FTC), 2) daily tenofovir alafenamide co-formulated with emtricitabine (TAF/FTC), 3) peri-coital TDF/FTC (“2-1-1 PrEP”), and 4) injectable long-acting cabotegravir. PrEP Choice is a package of three mobile health tools designed to increase the uptake and adherence to PrEP for YGBMSM, aged 13-24 years, to be tested in multiple sites in the United States. PrEP Choice consists of 1) MyPrEP, a website to help YGBMSM choose the type of PrEP that works best for them; 2) PrEPmate, a two- way SMS texting tool to check in with YGBMSM on a weekly basis and troubleshoot any problems with PrEP that arise; and 3) PrEPsmart, an app that reminds PrEP users taking PrEP pills when their next pill should be taken. These tools have been developed and tested individually; this is the first study to test the package of these tools to see if they increase the proportion of YGBMSM who take PrEP, and their adherence to PrEP once they start. The study begins by ensuring that PrEP Choice is relevant for both Spanish- and English- speaking YGBMSM across the country, through the use of focus groups, followed by a technical pilot in 20 YGBMSM, to work out any bugs in the system and to help determine how best to apply PrEP Choice in this population. Then, 200 YGBMSM not currently on PrEP will be recruited into a trial in which 100 are randomly chosen to get PrEP Choice, and the other 100 are randomly chosen to get a brochure describing the different types of PrEP available. After 9 months of follow-up, PrEP starts and use over time will be compared between the two groups. Then, the 100 participants initially given the brochure only will get access to the PrEP Choice package, and both groups will be followed for another 9 months to study their use of PrEP over time. PrEP use will be measured by testing for tenofovir diphosphate (TFV-DP) levels in dried blood spots (for the 3 types of PrEP that use pills) or the number of PrEP injections they get (for injectable long acting cabotegravir.) The primary outcome is PrEP use at 9 months into the study, and this study will enroll enough participants to be able to tell whether there is at least a 20% increase in the proportion of YGBMSM who use any PrEP in the PrEP Choice group compared with the brochure group, and a 22.5% increase in PrEP adherence (as measured by TFV-DP levels or administration of long-acting cabotegravir) in the PrEP Choice group compared with the brochure group. The cost and cost-effectiveness of the PrEP Choice package will also be assessed for YGBMSM. The trial will be conducted through the Adolescent Trials Network for HIV/AIDS Interventions (ATN), making use of their biostatistical and modeling resources, geographic and site diversity, and multidisciplinary expertise, including young advisors from the target population.

项目概要 2018年美国新增感染病例中，13-24岁的年轻人占21%，占81% 其中发生在年轻同性恋、双性恋和其他男男性行为者 (YGBMSM) 中。目前，有 YGBMSM 有 4 种不同的暴露前预防 (PrEP) 方案： 1) 每日替诺福韦 富马酸二吡呋酯与恩曲他滨 (TDF/FTC) 联合配制，2) 每日替诺福韦艾拉酚胺联合配制 恩曲他滨 (TAF/FTC)、3) 性交周围 TDF/FTC (“2-1-1 PrEP”) 和 4) 可注射的长效卡博特韦。 PrEP Choice 是一套包含三种移动健康工具的工具包，旨在提高 PrEP 的采用率和依从性 YGBMSM，年龄13-24岁，将在美国多个地点进行测试。 PrEP 选择包括 1) MyPrEP，一个帮助 YGBMSM 选择最适合他们的 PrEP 类型的网站； 2) PrEPmate，一种二元 Way SMS 短信工具每周检查 YGBMSM 并解决 PrEP 的任何问题 出现的； 3) PrEPsmart，一款应用程序，提醒 PrEP 用户服用 PrEP 药丸的时间 采取。这些工具是单独开发和测试的；这是第一个测试包的研究 这些工具，看看它们是否会增加 YGBMSM 采取 PrEP 的比例，以及他们对 PrEP 的坚持 一旦他们开始。该研究首先确保 PrEP 选择与西班牙语和英语相关 通过焦点小组在全国范围内宣传 YGBMSM，随后在 20 年进行了技术试点 YGBMSM，找出系统中的任何错误并帮助确定如何最好地在此应用 PrEP 选择 人口。然后，200 名目前未参加 PrEP 的 YGBMSM 将被招募到一项试验中，其中 100 名是随机的 选择获得 PrEP 选择，另外 100 人被随机选择以获得描述不同预防措施的小册子 可用的 PrEP 类型。 9 个月的随访后，将比较 PrEP 的开始和随时间的使用情况 两组。然后，最初收到手册的 100 名参与者将只能获得 PrEP 选择 包，两组都将被跟踪另外 9 个月，以研究他们随着时间的推移使用 PrEP 的情况。 PrEP 使用 将通过测试干血斑中的替诺福韦二磷酸 (TFV-DP) 水平来测量（针对 3 种类型） 使用药丸的 PrEP）或他们接受的 PrEP 注射次数（对于注射长效卡博特韦）。 主要结局是研究 9 个月时 PrEP 的使用，本研究将招募足够的参与者 能够判断在 YGBMSM 中使用任何 PrEP 的比例是否增加了至少 20% PrEP 选择组与手册组相比，PrEP 依从性增加了 22.5%（如 PrEP Choice 组中通过 TFV-DP 水平或长效卡博特韦的给药来测量） 与宣传册组。 PrEP Choice 套餐的成本和成本效益也将被评估 YGBMSM。该试验将通过艾滋病毒/艾滋病干预青少年试验网络（ATN）进行， 利用其生物统计和建模资源、地理和地点多样性以及多学科 专业知识，包括来自目标人群的年轻顾问。