RCT of a parent-focused intervention to reduce HIV risk in adolescent MSM

项目摘要 青春期男男性行为者(AMSM)占青年新感染艾滋病毒的79% 2018年美国(US)13-19。不到四分之一的AMSM曾接受过艾滋病毒检测。尽管 这些在艾滋病毒发病率和检测、降低性行为风险和增加艾滋病毒的干预措施方面的明显差异 在AMSM中进行的测试仍然非常有限。值得注意的是，极少数干预方法是 目前正在探索的AMSM不包括父母。忽略了以家长为中心的方法代表了一种 鉴于父母有据可查的塑造能力，在结束艾滋病毒流行的国家努力中存在明显差距 青春期性健康，包括AMSM。与美国国立卫生研究院的优先事项(PA-20-144)保持一致 拟议的研究旨在测试以父母为中心的干预措施的有效性，旨在降低艾滋病毒风险和 在AMSM中增加艾滋病毒检测。父母和青少年谈论健康的性行为(路径)是一种 我们为AMSM的父母创建了在线干预，旨在增加父母对性的沟通 和艾滋病毒，以及其他支持性风险降低的父母行为。我们由美国国立卫生研究院资助的试点随机对照试验 61个种族/民族不同的父母-AMSM二人组的全国样本显示，路径既增加了 父母和孩子报告了支持性健康的多个父母行为。在充满希望的基础上建设 路径对父母行为的影响，这项研究的目的是测试路径是否会改善 14-19岁AMSM的性健康结果。我们将对350个父AMSM进行路径RCT 在网上招募的二人组(50%的种族/少数民族)。父级将被随机化，以接收路径或 主动控制，然后在一年内每3个月评估一次。主要结果将在以下时间进行评估 干预后6个月，然后控制臂将交叉和接收路径，并将二元体 再随访6个月。这使我们能够进一步测试控制臂中路径的效果，同时 同时在原始干预组中模拟较长的9个月和12个月的影响。主要(P) 具体目标是：(P1)测试路径在提高AMSM准备程度方面的有效性 性交(操作为：获得避孕套，展示准确的避孕套技能，表达 打算使用避孕套，接受艾滋病毒检测，了解什么是PrEP，并表达阳性 对PrEP的态度)；和(P2)测试路径在减少无套肛交/阴道性交方面的有效性。 次级(S)的目标是：(S1)检查在P1和P2观察到的干预效果的程度 坚持干预后1年；以及(S2)研究父母行为如何在路径对 AMSM结果。如果被证明是有效的，路径将是第一批被证明可以减少 性风险和增加AMSM的艾滋病毒检测-艾滋病毒感染风险最高的青年人群 我们。此外，随着其他以青少年为重点的干预措施的出现，路径对父母的独特关注将提供 补充、额外的手段，帮助那些未被其他干预方案触及的AMSM。

Project Summary Adolescent men who have sex with men (AMSM) accounted for 79% of new HIV infections among youth ages 13-19 in the United States (US) in 2018. Less than a quarter of AMSM have ever taken an HIV test. Despite these stark disparities in HIV incidence and testing, interventions to reduce sexual risk and increase HIV testing among AMSM remain extremely limited. Notably, the very few intervention approaches that are currently being explored for AMSM exclude parents. The omission of parent-focused approaches represents a glaring gap in national efforts to end the HIV epidemic given parents’ well-documented ability to shape adolescent sexual health, including for AMSM. Consistent with NIH priorities (PA-20-144) the goal of the proposed research is to test the efficacy of a parent-focused intervention designed to reduce HIV risk and increase HIV testing among AMSM. Parents and Adolescents Talking about Healthy Sexuality (PATHS) is an online intervention we created for parents of AMSM that works to increase parent communication about sexuality and HIV, as well as other parent behaviors supportive of sexual risk reduction. Our NIH-funded pilot RCT with a national sample of 61 racially/ethnically diverse parent-AMSM dyads revealed that PATHS increased both parent and child reports of multiple parent behaviors supportive of sexual health. Building on the promising effects PATHS had on parent behaviors, the goal of the proposed study is to test whether PATHS improves sexual health outcomes in AMSM ages 14-19. We will conduct an RCT of PATHS with 350 parent-AMSM dyads recruited online (50% racial/ethnic minority). Parents will be randomized to receive either PATHS or an active control, and then assessed every 3 months over a 1-year period. Primary outcomes will be evaluated at 6 months post-intervention, and then the control arm will crossover and receive PATHS, and dyads will be followed for another 6 months. This allows us to further test the effects of PATHS in the control arm while simultaneously modeling the longer 9- and 12-month effects in the original intervention arm. The primary (P) specific aims are to: (P1) Test the efficacy of PATHS in improving the degree to which AMSM are prepared for intercourse (operationalized as: having access to condoms, demonstrating accurate condom skills, expressing intentions to use condoms, receiving HIV testing, understanding what PrEP is, and expressing positive attitudes toward PrEP); and (P2) Test the efficacy of PATHS in reducing condomless anal/vaginal intercourse. Secondary (S) aims are to: (S1) Examine the degree to which intervention effects observed in P1 and P2 persist to 1-year post intervention; and (S2) Examine how parent behaviors mediate effects of PATHS on AMSM outcomes. If proven efficacious, PATHS will be among the first interventions demonstrated to reduce sexual risks and increase HIV testing for AMSM – the population of youth at highest risk for HIV infection in the US. Moreover, as other adolescent-focused interventions emerge, PATHS’ unique focus on parents will offer a complementary, additional means for reaching AMSM who are not touched by other intervention options.