RP3 PrEP Choice

项目摘要 2018年，13-24岁的年轻人占美国新感染人数的21%， 这些发生在年轻的同性恋，双性恋和其他与男性发生性关系的男性（YGBMSM）。目前 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 与恩曲他滨（TDF/FTC）共同配制的富马酸二异丙酯，2）每日共同配制的替诺福韦艾拉酚胺 与恩曲他滨（TAF/FTC），3）性交周TDF/FTC（“2-1-1 PrEP”），和4）可注射的长效卡替拉韦。 PrEP Choice是一套由三种移动的健康工具组成的软件包，旨在提高PrEP的使用率和依从性 对于13-24岁的YGBMSM，将在美国的多个地点进行测试。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，一个两个- 一种短信工具，每周与YGBMSM进行检查，并解决PrEP的任何问题 出现;和3）PrEPsmart，一个应用程序，提醒服用PrEP药丸的PrEP用户，当他们的下一个药丸应该 满员你这些工具已经单独开发和测试;这是第一项测试 这些工具，看看他们是否增加了YGBMSM谁采取PrEP的比例，以及他们坚持PrEP 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， 通过使用焦点小组，在全国范围内讲YGBMSM，然后在20个国家进行技术试点， YGBMSM，以解决系统中的任何错误，并帮助确定如何最好地应用PrEP的选择， 人口然后，200名目前未接受PrEP的YGBMSM将被招募到一项试验中， 选择获得PrEP选择，其他100人随机选择获得描述不同 可用的PrEP类型。在9个月的随访后，将比较PrEP的开始和随时间的使用， 这两个群体。然后，最初仅获得小册子的100名参与者将获得PrEP Choice 包装，两组将被随访另外9个月，以研究他们随着时间的推移使用PrEP。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（对于3种类型的 使用药丸的PrEP）或他们获得的PrEP注射次数（对于可注射的长效cabotegravir）。的 主要结局是研究9个月时的PrEP使用，本研究将招募足够的参与者， 能够判断是否有至少20%的比例增加YGBMSM谁使用任何PrEP在 PrEP选择组与手册组相比，PrEP依从性增加了22.5%（作为 通过TFV-DP水平或长效cabotegravir给药测量）， 宣传册小组的人PrEP选择包的成本和成本效益也将进行评估， 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， 利用他们的生物统计和建模资源，地理和网站的多样性，以及多学科 专业知识，包括来自目标人群的青年顾问。

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.