ClinicalTrials.gg
TerminatedNCT06581536Yes and KnowUpdated Aug 19, 2026

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

An interventional study of Yes and Know curriculum and Nutrition Education for Adolescents in Pregnancy Related, Sexually Transmitted Diseases and Adolescent Behavior, sponsored by ETR Associates. Terminated at 1 site in United States. Open to participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by ETR Associates · Not applicable, Interventional, and Prevention

Why this study was terminated
The U.S. Department of Health and Human Services terminated funding for the study effective June 26, 2026.
Phase
Not applicable
Study type
Interventional
Enrollment
449
Allocation
Randomized
Ages
14 Years to 19 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Pregnancy Related
  • Sexually Transmitted Diseases
  • Adolescent Behavior
03

In context

Sexually Transmitted Diseases

523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.

This study's enrollment of 449 is close to the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

ETR Associates is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ages 14-19; and
  • English speaking.

Exclusion criteria

Exclusion Criteria:

- Anyone not meeting inclusion criteria.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
449 participants (actual)

Study arms

  • Experimental
    Yes and Know curriculum

    Youth will receive the Yes and Know curriculum.

    Behavioral: Yes and Know curriculum

  • Active comparator
    Nutrition Education for Adolescents

    Youth will receive education about adolescent nutrition.

    Behavioral: Nutrition Education for Adolescents

Interventions

  • BehavioralYes 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.

  • BehavioralNutrition 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.

06

What researchers measure

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-intervention

Secondary 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 intervention

  2. 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 intervention

  3. 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 intervention

  4. 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 intervention

  5. 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).

    Time frame: 3 months post intervention

07

Study locations

1 site
  • ETR Associates
    Watsonville, California 95076, United States
08

References and documents

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. PubMed 10537945 ↗
  • 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. PubMed 19685367 ↗
  • 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.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2025 to primary completion in Jun 2026, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2024
First posted
Sep 3, 2024
StartActual
Aug 6, 2025
Primary completionActual
Jun 26, 2026
CompletionActual
Jun 26, 2026
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06581536
Lead sponsor
ETR Associates
Responsible party
Sponsor
First posted
Sep 3, 2024
Start date
Aug 6, 2025
Primary completion
Jun 26, 2026
Completion
Jun 26, 2026
Last update
Aug 19, 2026

Study contacts

Rebecca A Braun, DrPH, MPH
principal investigator · ETR Associates
Pamela Anderson, PhD
principal investigator · ETR Associates

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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