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

项目摘要 男男性行为青少年（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曾经接受过艾滋病毒检测。尽管 艾滋病毒发病率和检测、减少性风险和增加艾滋病毒感染的干预措施方面存在明显差异 AMSM之间的测试仍然非常有限。值得注意的是，很少有干预措施， 目前正在探索AMSM排除父母。忽略以父母为中心的方法代表了一种 鉴于父母有充分证据证明的塑造能力， 青少年性健康，包括AMSM。与NIH优先事项（PA-20-144）一致， 拟议的研究是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， 增加对AMSM的艾滋病毒检测。父母和青少年谈论健康的性行为（PATHS）是一个 我们为AMSM的父母创建了在线干预，旨在增加父母对性行为的沟通 和艾滋病毒，以及其他父母行为支持性风险降低。我们的NIH资助的试点RCT， 61个种族/民族多样化的父母-AMSM二人组的全国样本显示，PATHS增加了 父母和孩子报告多个父母行为支持性健康。在有希望的基础上 PATHS对父母行为的影响，拟议研究的目标是测试PATHS是否改善 14-19岁AMSM的性健康结果。我们将对350名父母-AMSM进行PATHS的RCT 在网上招募的二人组（50%为少数民族）。父母将随机接受PATHS或 主动控制，然后在1年内每3个月进行一次评估。主要结局将在 干预后6个月，然后对照组交叉并接受PATHS， 再随访6个月。这使我们能够进一步测试PATHS在控制臂中的效果， 同时对原始干预组中较长的9个月和12个月效应进行建模。 具体目标是：（P1）测试PATHS在提高AMSM准备程度方面的功效， 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PATHS在减少无避孕套肛交/阴道性交中的疗效。 次要（S）目标是：（S1）检查在P1和P2中观察到的干预效果的程度 持续到干预后1年;（S2）检查父母行为如何介导PATHS对 AMSM结果。如果证明有效，PATHS将是首批被证明可以减少 性风险和增加对AMSM的艾滋病毒检测-艾滋病毒感染风险最高的青年人口， 我们此外，随着其他以儿童为中心的干预措施的出现，PATHS对父母的独特关注将为儿童提供一个 补充性的、额外的手段，帮助那些没有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.