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Project Legacy Impact Evaluation Study

Children's Hospital Los Angeles logo

Children's Hospital Los Angeles

Status

Completed

Conditions

Sexually Transmitted Diseases
Contraception Behavior
Sexual Behavior
Pregnancy Prevention

Treatments

Behavioral: Project Legacy

Study type

Interventional

Funder types

Other

Identifiers

NCT03366636
CHLA-17-00322

Details and patient eligibility

About

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.

Full 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.

Enrollment

571 patients

Sex

All

Ages

14 to 19 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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).

Exclusion criteria

  • Outside of age range
  • Currently pregnant
  • Not planning to be in the area for the length of the intervention
  • Previously enrolled in the study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

571 participants in 2 patient groups

Control
No Intervention group
Description:
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
Experimental group
Description:
The experimental/intervention arm will receive the Project Legacy intervention
Treatment:
Behavioral: Project Legacy

Trial contacts and locations

12

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Central trial contact

Frances J LaSalle-Castro, MPH; Mona Desai, MPH

Data sourced from clinicaltrials.gov

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