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Project Legacy Impact Evaluation Study

Project Legacy Impact Evaluation Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03366636
Enrollment
571
Registered
2017-12-08
Start date
2017-10-30
Completion date
2021-03-30
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception Behavior, Pregnancy Prevention, Sexual Behavior, Sexually Transmitted Diseases

Keywords

Pregnancy Prevention, Adolescents, STIs/STDs, Self-sufficiency

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.

Interventions

BEHAVIORALProject 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

Sponsors

ETR Associates
CollaboratorOTHER
Children's Hospital Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 monthsAssessed at baseline and 11 months post-baselineCurrent 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 monthsAssessed at baseline and 11 months post-baselineThis outcome measure is defined as the proportion of instances of vaginal and anal sex without a condom in the past 3 months.

Secondary

MeasureTime frameDescription
Current condom use (vaginal sex)Assessed at baseline, 5 months post-baseline, and 11 months post-baselineCurrent 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 contraceptionAssessed at baseline, 5 months post-baseline, and 11 months post-baselineThis 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 contraception use (among females)Assessed at baseline, 5 months post-baseline, and 11 months post-baselineCurrent contraception use is defined as the use of one or more methods of effective contraception in the past 3 months
Current marijuana or alcohol useAssessed at baseline, 5 months post-baseline, and 11 months post-baselineCurrent marijuana or alcohol use is defined as marijuana or alcohol use in the past 3 months
Sexual initiation / activity (vaginal)Assessed at baseline, 5 months post-baseline, and 11 months post-baselineEver engaged in vaginal sex.
Employment experience (current)Assessed at baseline, 5 months post-baseline, and 11 months post-baselineEmployed part or full-time since baseline; certificate, post-high school or college completed;
Engagement in job-readiness servicesAssessed at baseline, 5 months post-baseline, and 11 months post-baselineServices defined as job preparedness skill-building, job internships, or educational services
Social support (current)Assessed at baseline, 5 months post-baseline, and 11 months post-baselineSocial 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.
Stable living environment at the time of the follow-up (current)Assessed at baseline, 5 months post-baseline, and 11 months post-baselineStable living defined as living in a parents', relatives' or foster parents' home; a group home or residential facility or a tenant of an apartment.
Current birth control use (vaginal sex)Assessed at baseline, 5 months post-baseline, and 11 months post-baselineCurrent 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026