Project Legacy Impact Evaluation Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03366636
Study type	Interventional
Source	Children's Hospital Los Angeles
Contact
Status	Completed
Phase	N/A
Start date	October 30, 2017
Completion date	March 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02579135` - Reducing HIV Risk Among Adolescents: Evaluating Project HEART	N/A
Enrolling by invitation	`NCT06127277` - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care	N/A
Recruiting	`NCT05889689` - Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters	N/A
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Completed	`NCT03063385` - Puerto Rico Cuidalos Parent-adolescent Program	N/A
Completed	`NCT02009046` - Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students	N/A
Completed	`NCT01411878` - Louisville Teen Pregnancy Prevention Project	N/A
Completed	`NCT01303575` - Internet-Based Sexual Health Education for Middle School Native American Youth	N/A
Completed	`NCT00167505` - All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students	N/A
Completed	`NCT00183456` - A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs	Phase 2
Completed	`NCT00336180` - Adolescent Drug and HIV Prevention in South Africa	Phase 2/Phase 3
Completed	`NCT01084395` - Reducing HIV Risk Among Mexican Youth	N/A
Completed	`NCT00710060` - Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations	Phase 3
Completed	`NCT00161382` - Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students	N/A
Completed	`NCT00640653` - Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents	N/A
Completed	`NCT00289939` - Reducing HIV & Domestic Violence Risk in Women Offenders	Phase 3
Completed	`NCT00137943` - Parents Matter!: Interventions to Promote Effective Parent-Child Communication	Phase 1
Completed	`NCT03408743` - Engineering an Online STI Prevention Program: CSE2	N/A
Completed	`NCT06104813` - Evaluation of Deaf Men's Knowledge About Sexual Health
Not yet recruiting	`NCT05910580` - Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.