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

NCT ID: NCT06581536

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2027-08-31

Brief 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.

Detailed Description

For the Yes and Know study, cohorts of 5-15 participants will be recruited and randomized into one of the two study conditions: Yes and Know: Life Skills intervention (intervention condition) or Yes and Know: Nutrition Skills intervention (comparison condition). The programs will be delivered by trained health educators through synchronous virtual sessions. Participants can access the supplemental resources and activities for their respective programs on the program's website. Each cohort will be recruited from a local partner site (with a focus on rural communities in the South and Southeast regions of the United States), and young people must have consent and provide their assent to be part of the study. Yes and Know: Sexual Health and Life Skills covers sexual and reproductive health, healthy relationships, life skills, and educational and career success. Yes and Know: Nutrition Skills covers learning to make healthy decisions about food, weight and disordered eating, and creating nourishing meals. Both programs consist of nine 60-minute synchronous group sessions, totaling nine hours, to be taught at least once a week (or more frequently depending on sites' scheduling).

Conditions

Pregnancy Related; Sexually Transmitted Diseases; Adolescent Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Yes and Know curriculum

Youth will receive the Yes and Know curriculum.

Group Type: EXPERIMENTAL

Yes and Know curriculum

Intervention Type: 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

Youth will receive education about adolescent nutrition.

Group Type: ACTIVE_COMPARATOR

Nutrition Education for Adolescents

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ages 14-19; and
• English speaking.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

ETR Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca A Braun, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

ETR Associates

Karin K Coyle, PhD

Role: PRINCIPAL_INVESTIGATOR

ETR Associates

Locations

ETR Associates

Watsonville, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca A Braun, DrPH, MPH

Role: CONTACT

rebecca.braun@etr.org

510-858-0989

Karin K Coyle, PhD

Role: CONTACT

karin.coyle@etr.org

831-440-2140

Facility Contacts

Rebecca Braun, DrPH MPH

Role: primary

rebecca.braun@etr.org

510-858-0989

Karin Coyle, PhD

Role: backup

karin.coyle@etr.org

831-438-4060

References

Basen-Engquist K, Masse LC, Coyle K, Kirby D, Parcel GS, Banspach S, Nodora J. Validity of scales measuring the psychosocial determinants of HIV/STD-related risk behavior in adolescents. Health Educ Res. 1999 Feb;14(1):25-38. doi: 10.1093/her/14.1.25.

Reference Type: BACKGROUND

PMID: 10537945 (View on PubMed)

Humphreys TP, Brousseau MM. The sexual consent scale-revised: development, reliability, and preliminary validity. J Sex Res. 2010 Sep;47(5):420-8. doi: 10.1080/00224490903151358.

Reference Type: BACKGROUND

PMID: 19685367 (View on PubMed)

Scott, M.E., Moore, K.A., Fish, H., Benedetti, A., & Erikson, S. (2015). Healthy marriage and relationship education: Recommended outcome measures for adolescents. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.

Reference Type: BACKGROUND

Other Identifiers

TP2AH000079

Identifier Type: -

Identifier Source: org_study_id