Project Legacy Impact Evaluation Study
- Conditions
- Sexually Transmitted DiseasesSexual BehaviorContraception BehaviorPregnancy Prevention
- Interventions
- Behavioral: Project Legacy
- Registration Number
- NCT03366636
- Lead Sponsor
- Children's Hospital Los Angeles
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 571
- 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).
- Outside of age range
- Currently pregnant
- Not planning to be in the area for the length of the intervention
- Previously enrolled in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Project Legacy Project Legacy The experimental/intervention arm will receive the Project Legacy intervention
- Primary Outcome Measures
Name Time Method Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 months 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 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.
- Secondary Outcome Measures
Name Time Method Sexual initiation / activity (vaginal) Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Ever engaged in vaginal sex.
Social support (current) Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Social support is measured using The Multidimensional Scale of Perceived Social Support. Total scores range from 7 to 84 and each subscale score ranges from 4 to 28, with a higher score indicating greater social support. which are averaged together to get the total score.
Current contraception use (among females) Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Current contraception use is defined as the use of one or more methods of effective contraception in the past 3 months
Current birth control use (vaginal sex) Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Current birth control use is defined as the number of instances of vaginal sex during which contraception was used (including condoms) in the past 3 months.
Current condom use (vaginal sex) Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Current condom use for vaginal sex is defined as: the number of instances of vaginal sex during which condoms were used in the past 3 months
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 This outcome is defined as using contraception for less than 80% of instances of vaginal sex in the past 3 months.
1. "In the past 3 months, how many times did you have vaginal sex?"
2. "When you had vaginal sex in the past 3 months, how many times did you and your partner(s) have sex and NOT use any type of contraception (in other words, EITHER a condom OR other method of birth control)? By birth control, we mean using condom, birth control pills, the shot, the patch, the ring, IUD, or implant".Current marijuana or alcohol use Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Current marijuana or alcohol use is defined as marijuana or alcohol use in the past 3 months
Stable living environment at the time of the follow-up (current) Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Stable living defined as living in a parents', relatives' or foster parents' home; a group home or residential facility or a tenant of an apartment.
Employment experience (current) Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Employed part or full-time since baseline; certificate, post-high school or college completed;
Engagement in job-readiness services Assessed at baseline, 5 months post-baseline, and 11 months post-baseline Services defined as job preparedness skill-building, job internships, or educational services
Trial Locations
- Locations (12)
San Diego Youth Services
🇺🇸San Diego, California, United States
Five Keys
🇺🇸Boyle Heights, California, United States
Youth Program
🇺🇸Long Beach, California, United States
San Diego Central Library
🇺🇸San Diego, California, United States
YMCA of San Diego County
🇺🇸Oceanside, California, United States
Monarch School
🇺🇸San Diego, California, United States
Century Villages at Cabrillo
🇺🇸Long Beach, California, United States
Da Vinci Rise High
🇺🇸Los Angeles, California, United States
LA CAUSA Youth Build
🇺🇸Los Angeles, California, United States
Covenant House
🇺🇸Los Angeles, California, United States
Safe Place for Youth
🇺🇸Venice, California, United States
Los Angeles LGBT Center
🇺🇸Los Angeles, California, United States