Project Legacy Impact Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 12
- 主要终点
- Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 months
研究概览
简要总结
This study will design and rigorously evaluate the efficacy of Project Legacy, a five week positive youth development intervention to decrease sexual risk for unintended pregnancies and STIs among youth experiencing homelessness or at risk of homelessness aged 14-19. This randomized control trial will compare Project Legacy to a usual services control.
详细描述
The study uses a multi-site randomized group trial (RGT) cohort design to evaluate the Project Legacy intervention curriculum for reducing sexual risk behaviors among homeless youth age 14-19. CHLA project staff will work with 6 homeless youth serving sites in Southern California (Los Angeles, San Diego) to recruit 600 youth. Randomization to the intervention or control condition will occur at the group level and will be stratified by site. Field staff will survey all eligible homeless youth who provide consent to participate in the study at baseline (before randomization and implementation) and at 3 and 9 months post intervention (5-5.5 and 11-11.5 months post-baseline). The program group will receive an additional intervention-based survey immediately upon completion of the program.
Youth in the control condition will receive the normal standard of care provided at the recruitment sites. Services available as standard of care at the recruitment sites include: medical care; mental health services; substance abuse services; educational, career, and vocational services. Intervention participants will not be excluded from receiving these services as well. Surveys will capture mental and physical health care service utilization and services to reduce substance use across both groups. The study team will monitor HIV and pregnancy prevention programming and other similar goal-planning/decision-making interventions offered to homeless youth in the study areas during the program implementation and follow-up period via interviews with site staff. The study team will include selected program exposure items on the follow up surveys to assess youth's self-reported exposure to similar goal-planning/decision-making and sexual health (pregnancy prevention and STI/HIV) education.
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
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Served or identified on outreach by one of our partner homeless youth serving agencies in Los Angeles or San Diego
- •14-19 years of age
- •English-language speaker (able to complete consent and survey in English)
- •not currently pregnant
- •no immediate travel plans (are planning on being in the area for the length of the intervention - 8 weeks).
排除标准
- •Outside of age range
- •Currently pregnant
- •Not planning to be in the area for the length of the intervention
- •Previously enrolled in the study
研究组 & 干预措施
Control
The control/comparison group will be receiving only their usual services which are offered at the agencies they frequent, including mental health services, case management, job training, educational services, and, in specific venue contexts, may receive HIV risk reduction or other "sex education" interventions such as Street Smart. These same services are also open to the intervention group. Usage of these services varies by site (residential vs drop-in; city (San Diego vs Los Angeles) and type of service (case management, mental health, health care, etc.).
Project Legacy
The experimental/intervention arm will receive the Project Legacy intervention
干预措施: Project Legacy (Behavioral)
结局指标
主要结局
Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 months
时间窗: Assessed at baseline and 11 months post-baseline
Current use of contraception (including condoms) is defined as using contraception at \>80% of instances of vaginal intercourse in the past 3 months.
Change from baseline in current vaginal and anal sex without condom at 11 months
时间窗: Assessed at baseline and 11 months post-baseline
This outcome measure is defined as the proportion of instances of vaginal and anal sex without a condom in the past 3 months.
次要结局
- Current marijuana or alcohol use(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Stable living environment at the time of the follow-up (current)(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Employment experience (current)(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Engagement in job-readiness services(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Sexual initiation / activity (vaginal)(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Social support (current)(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Current contraception use (among females)(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Current birth control use (vaginal sex)(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Current condom use (vaginal sex)(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
- Proportion of youth who have vaginal intercourse without the consistent use of contraception(Assessed at baseline, 5 months post-baseline, and 11 months post-baseline)
研究者
Mona Desai
Principal Investigator
Children's Hospital Los Angeles