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Terminated

NCT Number: NCT06581536

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

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.

Why the study stopped: The U.S. Department of Health and Human Services terminated funding for the study effective June 26, 2026.
Terminated

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Key information

Conditions

Pregnancy Related Adolescent Behavior Behavior Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ETR Associates

Watsonville, California, 95076, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 14-19; and
  • English speaking.

Exclusion criteria

  • Anyone not meeting inclusion criteria.

Treatment and study plan

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.

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.

Primary outcomes

  1. Rates of unprotected vaginal or anal sex

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Sexual and reproductive health knowledge

    Time frame: 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

  3. Positive attitudes towards sexual consent

    Time frame: 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).

  4. Self-efficacy in relationship communication

    Time frame: 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).

  5. Self-efficacy in using condoms correctly

    Time frame: 3 months post intervention

    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).

Sponsors and collaborators

Lead sponsor

ETR Associates

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

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

Acronym: Yes and Know

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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