Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth

Part of paid clinical trials in Watsonville, California.

Sponsor
ETR Associates
Study ID
NCT06581536
Status
Recruiting
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Conditions

  • Adolescent Behavior
  • Pregnancy Related
  • Sexually Transmitted Diseases

Eligibility Criteria

Sex
ALL
Age
14 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Yes and Know curriculum — BEHAVIORAL
    Yes and Know is fully virtual intervention that integrates group-based education with digital tools to support young people ages 14 to 19 by increasing their relationship and healthy life skills. The curriculum focuses on sexual and reproductive health; healthy relationships; life skills; and educational and career success. It is delivered over nine synchronous sessions of 60-minutes each for a duration of nine hours, plus asynchronous online resources and activities.
  • Nutrition Education for Adolescents — BEHAVIORAL
    Youth will receive a fully virtual intervention that integrates group-based education with digital tools focused on adolescent nutrition and wellness. The curriculum is delivered over nine synchronous sessions of 60-minutes each for a duration of nine hours, plus asynchronous online resources and activities.

Study Details

This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.

Key Dates

Start date
Aug 6, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Yes and Know curriculum
    Youth will receive the Yes and Know curriculum.
  • Active Comparator: Nutrition Education for Adolescents
    Youth will receive education about adolescent nutrition.

Primary Outcome Measure

Rates of unprotected vaginal or anal sex [ Time Frame: 12 months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ETR AssociatesWatsonvilleCalifornia95076
Rebecca Braun, DrPH MPH
[email protected]
510-858-0989
Pamela Anderson, PhD
[email protected]
831-438-4060

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ETR Associates· Watsonville, CA

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