Wrap It Up Rigorous Evaluation

Part of paid clinical trials in Scotts Valley, California.

Sponsor
ETR Associates
Study ID
NCT06574321
Status
Enrolling By Invitation

Conditions

  • Pregnancy in Adolescence
  • Sexually Transmitted Diseases

Eligibility Criteria

Sex
ALL
Age
16 Years - 19 Years
Healthy Volunteers
Accepted

Interventions

  • Wrap It Up (WIU) — BEHAVIORAL
    WIU is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they move from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections. Most students this age will have received prior SHE. WIU is a 4-to-5-hour "booster" intervention, delivered in five 1-hour sessions during late high school, intended to enhance the effectiveness of previous SHE.

Study Details

Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties. Wrap It Up (WIU) is a sexual health education "booster" program for older high school students attending school in rural communities that was designed to help address this situation. Though there is preliminary evidence of the program's effectiveness, it has not yet been rigorously evaluated with a randomized controlled trial. WIU is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they move from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections. Most students this age will have received prior SHE. WIU is a 4-to-5-hour "booster" intervention, delivered during late high school, intended to enhance the effectiveness of previous SHE. The study's primary research question is: What is the impact at 6-months post baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days? The study's secondary research questions are: * What is the impact at 6-months post baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers, peers, and partners about their sexual health? * What is the impact at 6-months post-baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services? * What is the impact at 12-months post-baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?

Key Dates

Start date
Oct 29, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: WIU Intervention
    Intervention: Students in schools in this group will receive Wrap It Up, a 4-to-5-session SHE "booster" program
  • No Intervention: Comparison
    "Business-as-usual" control: Students in schools in this group will receive their school's normal classroom teaching

Primary Outcome Measure

No vaginal or anal sex, or use of condoms or effective birth control if having sex, in past 90 days [ Time Frame: 6 months post-baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
ETRScotts ValleyCalifornia95066-

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ETR· Scotts Valley, CA

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