An interventional study of Project Legacy in Pregnancy Prevention, Sexual Behavior and Contraception Behavior, sponsored by Children's Hospital Los Angeles. Completed at 12 sites in United States. Open to participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Prevention
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.
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.
224 studies on the registry are indexed under Sexual Behavior; 30 are open to participants now.
This study's enrollment of 571 is above the median of 264 across 179 interventional studies indexed under Sexual Behavior.
Browse Sexual Behavior studies →Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.).
The experimental/intervention arm will receive the Project Legacy intervention
Behavioral: Project Legacy
Project Legacy - Project Legacy is a 5-week, twice a week, 10 sessions small group intervention that encourages homeless and at-risk of homeless youth ages 14-19 to imagine a positive future and discuss how current risk behaviors can be a barrier to a successful adulthood. The program includes thinking about the future, the importance of positive social supports, short and long-term goal planning, and decision making. The program also includes life skills building, addressing past and current risk behaviors, linking to resources and navigating service systems, information on contraception and condoms, a healthy life plan and self-sufficiency. The 5 content core elements are the following: * 1. Thinking about the future * 2. Present actions to achieve future success * 3. Safeguarding one's future * 4. Creating a Healthy Life Plan * 5. Navigating service systems
Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 months
Current use of contraception (including condoms) is defined as using contraception at \>80% of instances of vaginal intercourse in the past 3 months.
Time frame: Assessed at baseline and 11 months post-baseline
Change from baseline in current vaginal and anal sex without condom at 11 months
This outcome measure is defined as the proportion of instances of vaginal and anal sex without a condom in the past 3 months.
Time frame: Assessed at baseline and 11 months post-baseline
Sexual initiation / activity (vaginal)
Ever engaged in vaginal sex.
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current birth control use (vaginal sex)
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.
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current condom use (vaginal sex)
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
Time frame: 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
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".
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current contraception use (among females)
Current contraception use is defined as the use of one or more methods of effective contraception in the past 3 months
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current marijuana or alcohol use
Current marijuana or alcohol use is defined as marijuana or alcohol use in the past 3 months
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Stable living environment at the time of the follow-up (current)
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.
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Employment experience (current)
Employed part or full-time since baseline; certificate, post-high school or college completed;
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Engagement in job-readiness services
Services defined as job preparedness skill-building, job internships, or educational services
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Social support (current)
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.
Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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