Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,100
- 试验地点
- 2
- 主要终点
- HIV incidence
研究概览
简要总结
The LifeSkills Mobile app will be evaluated in a randomized controlled trial (RCT) among 5,000 young transgender women (YTW), ages 16-29 in the United States (U.S.). Study findings will demonstrate if the intervention will reduce HIV incidence.
详细描述
LifeSkills Mobile is an mHealth intervention to promote biobehavioral HIV prevention strategies based on empowerment theory and was developed using a community-based participatory research approach. An RCT assesses the efficacy of the LifeSkills Mobile intervention in comparison to a standard of care (SOC) condition among 5,000 YTW recruited online. At baseline and every 6 months through 12-48 months (depending on when the participant enrolled), enrolled participants will complete an online survey sent via a link to their mobile phone and will be mailed an OraQuick In-Home HIV Test kit. We will also estimate the total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 29 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Self-identified as transgender, woman, and/or along the feminine spectrum with a male assigned sex at birth
- •Ages 16-29
- •HIV uninfected at enrollment visit, verified via HIV home test kit
- •Self-reported lifetime history of condomless sex or recent history of sex (anal or vaginal in the past 12 months)
- •Able to speak/understand English
- •Owns a smartphone or home computer or willing to use one in the study
- •Willing and able to provide informed consent/assent
排除标准
- •Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at time of enrollment
- •Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of the interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
- •A positive Home HIV test kit result at baseline; these individuals will be immediately linked to HIV clinical care in their local areas.
结局指标
主要结局
HIV incidence
时间窗: 12-48 months post-baseline (depending on when participants enroll in the study)
Participants will be mailed and take an OraQuick In-Home HIV Test. Reactive HIV screening tests will be confirmed via dried blood spot (DBS; detectable antibodies). The main analysis will assess whether there are differences in survival (or cumulative incidence of HIV) among those randomized to LifeSkills Mobile versus those randomized to SOC.
次要结局
- Changes in sexual risk behavior at 24 months based on self-report(24 months post-baseline)
- Changes in sexual risk behavior at 30 months based on self-report(30 months post-baseline)
- PrEP outcomes (linkage, initiation, retention)(12-48 months post-baseline (depending on when participants enroll in the study))
- Changes in sexual risk behavior at 18 months based on self-report(18 months post-baseline)
- Changes in sexual risk behavior at 12 months based on self-report(12 months post-baseline)
- Changes in sexual risk behavior at 36 months based on self-report(36 months post-baseline)
- Comparison of costs between LifeSkills Mobile intervention vs SOC(End of study)
- Changes in sexual risk behavior at 6 months based on self-report(6 months post-baseline)
- Changes in sexual risk behavior at 42 months based on self-report(42 months post-baseline)
- Changes in sexual risk behavior at 48 months based on self-report(48 months post-baseline)
研究者
Matthew Mimiaga, ScD, MPH, MA
Professor of Epidemiology, UCLA Fielding School of Public Health, and Psychiatry & Biobehavioral Sciences, UCLA David Geffen School of Medicine
University of California, Los Angeles