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

NCT06581536 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-05-14

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy Related
  • Sexually Transmitted Diseases
  • Adolescent Behavior

Interventions

BEHAVIORAL

Yes and Know curriculum

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.

BEHAVIORAL

Nutrition Education for Adolescents

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.

Sponsors & Collaborators

Principal Investigators

  • Rebecca A Braun, DrPH, MPH · ETR Associates

  • Pamela Anderson, PhD · ETR Associates

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06581536 on ClinicalTrials.gov