Clinical trial NCT03366636: Project Legacy Impact Evaluation Study
Official title: Project Legacy Impact Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Prevention
Sexual Behavior
Contraception Behavior
Sexually Transmitted Diseases
Keywords: Pregnancy Prevention
Adolescents
STIs/STDs
Self-sufficiency
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: ETR Associates
First posted: 2017-12-08
Enrollment: 571
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 months
timeFrame: Assessed at baseline and 11 months post-baseline
measure: Change from baseline in current vaginal and anal sex without condom at 11 months
timeFrame: Assessed at baseline and 11 months post-baseline
Secondary outcomes:
measure: Sexual initiation / activity (vaginal)
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Current birth control use (vaginal sex)
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Current condom use (vaginal sex)
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Proportion of youth who have vaginal intercourse without the consistent use of contraception
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Current contraception use (among females)
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Current marijuana or alcohol use
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Stable living environment at the time of the follow-up (current)
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Employment experience (current)
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Engagement in job-readiness services
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
measure: Social support (current)
timeFrame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Other outcomes:
Locations:
city: Boyle Heights
country: United States
facility: Five Keys
state: California
city: Long Beach
country: United States
facility: Youth Program
state: California
city: Long Beach
country: United States
facility: Century Villages at Cabrillo
state: California
city: Los Angeles
country: United States
facility: Da Vinci Rise High
state: California
city: Los Angeles
country: United States
facility: LA CAUSA Youth Build
state: California
city: Los Angeles
country: United States
facility: Covenant House
state: California
city: Los Angeles
country: United States
facility: Los Angeles LGBT Center
state: California
city: Oceanside
country: United States
facility: YMCA of San Diego County
state: California
city: San Diego
country: United States
facility: San Diego Central Library
state: California
city: San Diego
country: United States
facility: San Diego Youth Services
state: California
city: San Diego
country: United States
facility: Monarch School
state: California
city: Venice
country: United States
facility: Safe Place for Youth
state: California
Study officials:
affiliation: University of Southern California
name: Leslie F Clark, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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