Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorETR Associates
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 14-19; and
English speaking.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Yes and Know curriculum
BehavioralYes 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
BehavioralYouth 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.
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Yes and Know curriculumExperimental treatment 1 intervention
Group B: Nutrition Education for AdolescentsActive comparator 1 intervention
Trial outcomes
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.
Time frame
12 months post-interventionSecondary outcomes
1
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.
Time frame
12 months post intervention2
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
Time frame
3 months post intervention3
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).
Time frame
3 months post intervention4
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).
Time frame
3 months post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
ETR Associates
Lead sponsor
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov