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Completed

NCT Number: NCT03366636

Project Legacy Impact Evaluation Study

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.

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Key information

Conditions

Pregnancy Prevention Behavior Communicable Diseases Contraception Behavior Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Reproductive Behavior Sexual Behavior Sexually Transmitted Diseases Urogenital Diseases

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Five Keys, Boyle Heights, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project Legacy

Behavioral

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

Primary outcomes

  1. Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 months

    Time frame: 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.

  2. Change from baseline in current vaginal and anal sex without condom at 11 months

    Time frame: 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 outcomes

  1. Sexual initiation / activity (vaginal)

    Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline

    Ever engaged in vaginal sex.

  2. Current birth control use (vaginal sex)

    Time frame: 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.

  3. Current condom use (vaginal sex)

    Time frame: 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

  4. Proportion of youth who have vaginal intercourse without the consistent use of contraception

    Time frame: 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.

    • "In the past 3 months, how many times did you have vaginal sex?"
    • "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".

  5. Current contraception use (among females)

    Time frame: 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

  6. Current marijuana or alcohol use

    Time frame: 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

  7. Stable living environment at the time of the follow-up (current)

    Time frame: 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.

  8. Employment experience (current)

    Time frame: 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;

  9. Engagement in job-readiness services

    Time frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline

    Services defined as job preparedness skill-building, job internships, or educational services

  10. Social support (current)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • ETR Associates

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2017
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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