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临床试验/NCT05848570
NCT05848570招募中不适用

Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention

Hektoen Institute for Medical Research1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2023年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
6,000
试验地点
1
主要终点
Sexual Behavior Questionnaire

研究概览

简要总结

Despite advances in HIV diagnostics, care and prevention strategies, infection rates among adolescent and young adult sexual and gender minorities (SGM) continue to rise in the United States (US). There is an urgent need to describe the epidemiology and trajectories of HIV acquisition in this population and to offer age and culturally appropriate scalable prevention interventions to those at highest risk of infection in the US. This project will engage and retain young SGM in an innovative longitudinal cohort, enroll participants in a dynamic established digital health retention platform (HMP; HealthMPowerment), monitor HIV risk and prevention behaviors and explore the socioecological factors that influence the use of new HIV prevention technologies (UG3 phase), while also allowing targeted testing of novel digital health interventions (UH3 phase). In Aim 1, the investigators will enroll and retain a large (n=6000; 3000/year), diverse cohort of sexually active, SGM adolescents and young adults, ages 13-34, using innovative digital recruitment, engagement and retention strategies. Over the course of the study, the investigators will longitudinally characterize the sexual behavior, HIV transmission risk, and PrEP uptake trajectories of SGM youth utilizing epidemiological trajectory analyses to identify the most effective points of intervention (Aim 2). This study will capitalize upon productive existing partnerships and digital health expertise to articulate the drivers of the ongoing HIV epidemic among the most vulnerable populations in the US in order to identify the most effective, expeditious and scalable strategies to address this ongoing public health crisis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 34 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • For young adults ages 18-34: self-identified SGM young adults ages 18-34 who meet at least one of the following criteria:
  • condomless anal or vaginal intercourse (CAI) with a cisgender man in the last 6 months OR
  • sex with cisgender men and bacterial STI in the last 6 months OR
  • anal or vaginal sex with a known HIV-infected partner in the last 6 months.
  • For adolescents 13-17: self-identified SGM adolescents ages 13-17 who have engaged in any sexual activity (e.g., oral, anal or vaginal sex)

排除标准

  • under age 13
  • over age 34

结局指标

主要结局

Sexual Behavior Questionnaire

时间窗: past 6 months

oral, anal and vaginal sex episodes

HIV Testing Result

时间窗: past 12 months

HIV seroconversion

次要结局

  • PrEP uptake(past 6 months)

研究者

发起方
Hektoen Institute for Medical Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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