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.

项目总结 2018年，13-24岁的年轻人占美国新增感染人数的21%，占81% 其中发生在年轻的同性恋、双性恋和其他与男性发生性行为的男性(YGBMSM)中。目前，有 是否有4种不同的暴露前预防(PrEP)方案可用于YGBMSM：1)每日替诺福韦 富马酸异丙酚与恩曲他滨联合制剂(TDF/FTC)，2)每日替诺福韦丙氨酰胺联合制剂 用恩曲他滨(TAF/FTC)，3)围产期TDF/FTC(“2-1-1 PrEP”)，和4)注射长效卡波替格韦。 Prep Choice是一个由三个移动健康工具组成的套餐，旨在增加对PrEP的接受和遵守 对于13-24岁的YGBMSM，将在美国的多个地点进行测试。备考选择包括1) MyPrEP，一个帮助YGBMSM选择最适合他们的PrEP类型的网站；2)PrEPmate，一个两个- 短信工具每周与YGBMSM签到，并解决PrEP的任何问题 3)PrEPSmart，一款提醒PrEP用户何时服用PrEP药片的应用程序 有人了。这些工具是单独开发和测试的；这是第一个测试 这些工具旨在了解他们是否增加了服用PrEP的YGBMSM的比例，以及他们对PrEP的依从性 一旦他们开始了。这项研究首先确保PrEP Choice与西班牙语和英语都相关。 通过使用焦点小组在全国范围内进行YGBMSM演讲，随后在20个月内进行技术试点 YGBMSM，以找出系统中的任何错误，并帮助确定如何最好地应用PrEP Choice 人口。然后，200名目前不在PrEP上的YGBMSM将被招募到一项试验中，其中100人是随机的 选择获得PrEP Choice，并随机选择其他100人，以获得一本介绍不同 可用的PrEP类型。在9个月的随访后，将比较PrEP的启动和随时间的使用情况 两组。然后，最初仅获得小册子的100名参与者将获得PrEP Choice的访问权限 两组都将被跟踪观察9个月，以研究他们随着时间的推移使用PrEP的情况。准备使用 将通过检测干血斑中的替诺福韦二磷酸(TFV-DP)水平来测量(对于三种类型的 准备使用药丸)或他们得到的PrEP注射的次数(对于可注射的长效卡波替格韦)。这个 主要结果是在研究9个月时使用PrEP，这项研究将招募足够的参与者 能够判断YGBMSM中使用任何PrEP的比例是否至少增加了20% Prep Choice组与宣传册组相比，PrEP依从性(AS)提高了22.5% 以TFV-DP水平或长效卡替格雷的剂量测量)在PrEP Choice组中进行比较 与宣传册小组合作。还将评估PrEP Choice一揽子计划的成本和成本效益 YGBMSM。该试验将通过青少年艾滋病毒/艾滋病干预试验网络(ATN)进行， 利用他们的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。