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

NCT06581536 | Recruiting

• 1 other identifier: TP2AH000079
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexually Transmitted Diseases; Pregnancy Related; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• Rates of unprotected vaginal or anal sex

  Single measure constructed from the number of times had vaginal sex without a contraceptive method in the past 3 months; number of times had anal sex without a condom in the past 3 months.

  12 months post-intervention

Secondary Outcomes (5)

• Use of sexual and reproductive health services in the past 3 months

  12 months post intervention

• Sexual and reproductive health knowledge

  3 months post intervention

• Positive attitudes towards sexual consent

  3 months post intervention

• Self-efficacy in relationship communication

  3 months post intervention

• Self-efficacy in using condoms correctly

  3 months post intervention

Study Arms (2)

Yes and Know curriculum

EXPERIMENTAL

Youth will receive the Yes and Know curriculum.

Behavioral: Yes and Know curriculum

Nutrition Education for Adolescents

ACTIVE COMPARATOR

Youth will receive education about adolescent nutrition.

Behavioral: Nutrition Education for Adolescents

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.

Yes and Know curriculum

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.

Nutrition Education for Adolescents

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 14-19; and
• English speaking.

Sponsors & Collaborators

• ETR Associates: lead
• University of California, San Francisco: collaborator

Study Sites (1)

ETR Associates

Watsonville, California, 95076, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 10537945 BACKGROUND

• 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.

  PMID: 19685367 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases; Adolescent Behavior

Interventions

YES1 protein, human; Nutrition Assessment

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Rebecca A Braun, DrPH, MPH

  ETR Associates

  PRINCIPAL INVESTIGATOR

• Karin K Coyle, PhD

  ETR Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca A Braun, DrPH, MPH

CONTACT

510-858-0989; rebecca.braun@etr.org

Karin K Coyle, PhD

CONTACT

831-440-2140; karin.coyle@etr.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 3, 2024
• Study Start: August 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)