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

Rigorous Evaluation of Yes and Know, a Fully Virtual Intervention Integrating Group-based Education With Digital Tools to Improve Youth Sexual Health and Well-Being

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.

Study Overview

• Status: Recruiting
• Conditions: Sexually Transmitted Diseases; Pregnancy Related; Adolescent Behavior
• Intervention / Treatment: Behavioral: Yes and Know curriculum; Behavioral: Nutrition Education for Adolescents

Detailed Description

For the Yes and Know study, cohorts of 5-25 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. Participants will be recruited by local community partners (with a focus on rural communities in the South and Southeast regions of the United States) as well as paid advertising on social media platforms. 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 cohort scheduling).

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca A Braun, DrPH, MPH; Phone Number: 510-858-0989; Email: rebecca.braun@etr.org
• Study Contact Backup: Name: Pamela K Anderson, PhD; Phone Number: 831-438-4060; Email: pamela.anderson@etr.org

Study Locations

• United States
  • California
    • Watsonville, California, United States, 95076
      • Recruiting
      • ETR Associates
      • Contact: Rebecca Braun, DrPH MPH; Phone Number: 510-858-0989; Email: rebecca.braun@etr.org
      • Contact: Pamela Anderson, PhD; Phone Number: 831-438-4060; Email: pamela.anderson@etr.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ages 14-19; and
• English speaking.

Exclusion Criteria:

- Anyone not meeting inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yes and Know curriculum; Youth will receive the Yes and Know curriculum.	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.
Active Comparator: Nutrition Education for Adolescents; Youth will receive education about adolescent nutrition.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of sexual and reproductive health services in the past 3 months	Single dichotomous (yes/no) measure of whether the participant received any sexual or reproductive health services from a health care provider in the past 3 months, including condoms or other contraceptive methods, STI/HIV testing, prenatal care, or sexual health information.	12 months post intervention
Sexual and reproductive health knowledge	A measure of the % of correct answers (0% to 100%) on six survey questions that assess knowledge of sexual and reproductive health, developed for the study	3 months post intervention
Positive attitudes towards sexual consent	A measure comprised of 3 questions that assesses positive attitudes towards sexual consent. Scale scores range from 3 to 15 based on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).	3 months post intervention
Self-efficacy in relationship communication	A measure comprised of 5 questions that assesses perceived self-efficacy in healthy relationship communication. Scale scores range from 5 to 25 based on a 5-point Likert scale (1 = not at all confident, 5=very confident).	3 months post intervention
Self-efficacy in using condoms correctly	A measure comprised of 3 questions that assesses perceived self-efficacy in using condoms correctly. Scale scores range from 5 to 25 based on a 5-point Likert scale (1 = not at all confident, 5=very confident).	3 months post intervention

Collaborators and Investigators

• Sponsor: ETR Associates
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Rebecca A Braun, DrPH, MPH, ETR Associates; Principal Investigator: Pamela Anderson, PhD, ETR Associates

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Sexually Transmitted Diseases; Adolescent Behavior; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment; YES1 protein, human
• Other Study ID Numbers: TP2AH000079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No