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

Not Applicable

Recruiting

• Conditions: Pregnancy Related; Sexually Transmitted Diseases; Adolescent Behavior

• Registration Number: NCT06581536
• Lead Sponsor: ETR Associates

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).

Study Timeline

• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-09-03
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Ages 14-19; and
• English speaking.

Exclusion Criteria

• Anyone not meeting inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rates of unprotected vaginal or anal sex	12 months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Use of sexual and reproductive health services in the past 3 months	12 months post intervention	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.
Sexual and reproductive health knowledge	3 months post intervention	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
Positive attitudes towards sexual consent	3 months post intervention	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).
Self-efficacy in relationship communication	3 months post intervention	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).
Self-efficacy in using condoms correctly	3 months post intervention	A measure comprised of 3 questions that assesses perceived self-efficacy in using condoms correctly.; Scale scores range from 3 to 12 based on a 4-point Likert scale (1 = no, definitely not, 4 = yes, definitely).

Trial Locations

Locations (1)

ETR Associates; 🇺🇸 Watsonville, California, United States