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临床试验/NCT03511131
NCT03511131已完成不适用

A Pragmatic Trial of An Adaptive eHealth HIV Prevention Program for Diverse Adolescent MSM

Northwestern University2 个研究点 分布在 1 个国家目标入组 1,306 人开始时间: 2018年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,306
试验地点
2
主要终点
Condomless anal sex

研究概览

简要总结

This pragmatic trial of an HIV prevention program focuses on HIV risk-reduction in men who have sex with men (MSM) ages 13-18. The design is a three-tiered, internet-based HIV prevention intervention series that uses a sequential multiple assignment randomized trial (SMART) to track adolescent MSM reporting varying degree of sexual risk.The program package includes: (1-low risk) a universally-delivered, brief, online sexual health education program designed for sexual and gender minority youth regardless of whether they are sexually active (Queer Sex Ed); (2-middle risk) a more intensive online intervention designed for diverse AMSM engaging in HIV transmission risk behaviors (Keep It Up!), and (3-high risk) the most intensive is a motivational interviewing (MI) intervention that will be delivered by MI therapists via online videochat (Young Men's Health Project).

详细描述

Adolescent (ages 13-18) men who have sex with men (AMSM) experience a dramatic health disparity as they represent 2% of young people but account for almost 80% of HIV diagnoses in youth. Despite this disproportionate burden, current evidence-based HIV prevention programs focus primarily on adults and heterosexual youth. Because issues affecting sexual health decisions among AMSM are unique, interventions need to be designed to ensure appropriate content that resonates with AMSM. Prevention programs must also be responsive to minority AMSM that experience disparities in incidence or lack of access to prevention services. For example, Hispanics represent 27% of HIV infections among MSM, but Spanish speaking MSM face significant language barriers to accessing HIV services.

Implementation issues are particularly critical as traditional HIV prevention delivery channels have significant limitations for AMSM: few adolescents attend LGBT youth oriented programs, schools place many restrictions on discussions of MSM sexual health, and major questions remain as to the feasibility of enrolling parents of AMSM into HIV prevention programs. With 92% of adolescents (across all races and income levels) going online every day, eHealth interventions represent a critical modality for delivering AMSM- specific intervention material where youth "are." Combining online recruitment with intervention delivery across a range of devices can overcome many access barriers to engagement of AMSM in HIV prevention.

Unfortunately, there will be no single magic solution that will work for all AMSM and public health programmers should not continue to deliver the same fixed intervention when a participant is not responding. Alternatively, stepped-care strategies increase in intensity to meet the needs of those who do not respond to a less intense intervention. Using a Sequential Multiple Assignment Randomized Trial (SMART) design, the investigators will evaluate the impact of a package of increasingly intensive interventions that have already shown evidence of efficacy with diverse adolescent and young adult MSM. The SMART methodology is an ideal approach because SMART designs mimic treatment decisions as they are made in real-world clinical settings, components of traditional RCTs are embedded within the design, and participant data can be used post-hoc to inform decision rules in order to optimize implementation. Collectively the investigators brand this package of eHealth interventions as the SMART Program (Sexual Minority Adolescent Risk Taking). The SMART Program package includes: (1) a universally-delivered, brief, online sexual health education program designed for sexual and gender minority youth regardless of whether they are sexually active ("Queer Sex Ed") (2) a more intensive online intervention designed for diverse AMSM engaging in HIV transmission risk behaviors ("Keep It Up!"); and (3) a more intensive motivational interviewing (MI) intervention that will be delivered by MI therapists via online videochat ("Young Men's Health Project"). The investigators will evaluate the impact of the SMART Program and carefully document implementation context to inform scale out with the following aims:

Aim 1: Evaluate the impact of the SMART Program and its constituent components at reducing HIV risk among AMSM. To do this, the investigators will:

  1. Involve diverse AMSM (e.g., Youth Advisory Council) in developmentally adapting existing SMART Program components for AMSM ages 13-18 using the ADAPT-ITT framework.
  2. Culturally and linguistically adapt the SMART Program for Spanish speaking Latino AMSM in the US.
  3. Embed the SMART Program content into an eHealth platform that will allow access on a range of devices and accommodate updates. Perform alpha and beta testing.
  4. Enroll a national sample of 1,938 AMSM who are diverse in terms of race/ethnicity, age, geographic region, socioeconomic status, and sexual experience history.
  5. Test the effectiveness of the SMART Program at reducing HIV risk taking behaviors, increasing HIV testing, and improving prevention intentions. Consistent with a SMART design, the investigators operationalize and power the primary test of effectiveness as the first point of randomization, which tests the effectiveness of "Keep It Up!". Additional comparisons will allow the investigators to establish the response rate for "Queer Sex Ed", examine whether the more intensive "Young Men's Health Project" outperforms the less intensive "Keep It Up!" among non-responders to "Queer Sex Ed," and determine whether "Young Men's Health Project" provides added benefit to AMSM who did not respond to "Keep it Up!".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • identifying as male-assigned at birth
  • reporting attraction to men;
  • 13-18 years old
  • self-reported HIV-negative at the beginning of the study (or have never been HIV tested/do not know their HIV status)
  • able to read English or Spanish,
  • has a usable e-mail address, textable phone number, and access to the internet or smart-phone/-device

排除标准

  • identifying as female-assigned at birth
  • reporting no attraction men
  • identifying as under 13 years of age
  • identifying as 19 years old or older
  • self-reported HIV-positive
  • unable to read English or Spanish
  • unable to have access to or use email, text messaging, voice calling
  • unable to have access to the internet or a smart-phone/-device

结局指标

主要结局

Condomless anal sex

时间窗: 12-months

Changes in condomless anal sex acts from baseline to 12-months.

HIV Testing

时间窗: 12-months

Participants are asked to self-reported their history of actual getting HIV tested.

Condom Use Intentions Scale

时间窗: 12-months

This is a multi-item scale which asks participants about their plans and abilities to use condoms in the future. It has two subscales. The first subscale (Condom Use) asks about participants' likelihood to use condoms with partners. An example item for Condom Use is: "How likely is it that you will use a condom every time you have sex?" The 11-items for this subscale are measured from very unlikely (1) to very likely (4) \[averaged min value 1, averaged max value 4\]. High values mean a better outcome, or likely condom use with partners. The second subscale (Self-Efficacy) asks participants' ability to use condoms. An example item for Self-Efficacy is: "How confident are you that you would be able to be sure you had condoms with you?" The 5-items for this subscale are measured from not at all confident (1) to extremely confident (7) \[averaged min value 1, averaged max value 7\]. High values mean a better outcome, or more confidence at using condoms. The two subscales are not combined.

次要结局

  • HIV Knowledge(Months: 0, 3, 6, 9, 12)
  • HIV/AIDS Motivation and Behavioral Skills(Months: 0, 3, 6, 9, 12)
  • Condom Errors(Months: 0, 3, 6, 9, 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Mustanski

Professor, Medical Social Sciences

Northwestern University

研究点 (2)

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