Pregnancy RelatedYes and KnowNCT06581536
Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth
A study testing Yes and Know curriculum and Nutrition Education for Adolescents in people with Pregnancy Related and Sexually Transmitted Diseases, run by ETR Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Pregnancy Related, Sexually Transmitted Diseases, Adolescent Behavior
- What is being tested?
- Yes and Know curriculum and Nutrition Education for Adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2025to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 14-19; and
- English speaking.
Who cannot join
- Anyone not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
- Being tested
- Yes and Know curriculum, Nutrition Education for Adolescents
- Medical subject headings
- Sexually Transmitted Diseases, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yes and Know curriculumBehavioural
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 AdolescentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yes and Know curriculum | Experimental | Youth will receive the Yes and Know curriculum. Receives: Behavioral: Yes and Know curriculum |
| Nutrition Education for Adolescents | Active comparator | Youth will receive education about adolescent nutrition. Receives: Behavioral: Nutrition Education for Adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-intervention
Secondary outcomes (5)
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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start6 Aug 2025
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Why it stopped: The U.S. Department of Health and Human Services terminated funding for the study effective June 26, 2026.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETR Associates
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Rebecca A Braun, DrPH, MPH, Principal investigator, ETR AssociatesPamela Anderson, PhD, Principal investigator, ETR Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581536
- Sponsor's protocol ID
- TP2AH000079
- Acronym
- Yes and Know
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 10537945Humphreys 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 19685367Scott, 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 at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06581536
- Acronym / sponsor ID
- Yes and Know / TP2AH000079
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The U.S. Department of Health and Human Services terminated funding for the study effective June 26, 2026.
- Enrolment
- 449 participants (actual)
- Lead sponsor
- ETR AssociatesUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 5-25 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yes and Know curriculum | Experimental | Behavioral: Yes and Know curriculumYouth will receive the Yes and Know curriculum. |
| Nutrition Education for Adolescents | Active comparator | Behavioral: Nutrition Education for AdolescentsYouth will receive education about adolescent nutrition. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 14-19; and
- English speaking.
Key exclusion criteria (1 listed)
- Anyone not meeting inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yes and Know curriculumYes 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. | Behavioural | Yes and Know curriculum |
| Nutrition Education for AdolescentsYouth 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. | Behavioural | Nutrition Education for Adolescents |
Primary outcome
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.
5 secondary outcomes
Use of sexual and reproductive health services in the past 3 months
Time frame: 12 months post intervention
Sexual and reproductive health knowledge
Time frame: 3 months post intervention
Positive attitudes towards sexual consent
Time frame: 3 months post intervention
Self-efficacy in relationship communication
Time frame: 3 months post intervention
Self-efficacy in using condoms correctly
Time frame: 3 months post intervention
Results and safety
The study was stopped early (reason given: The U.S. Department of Health and Human Services terminated funding for the study effective June 26, 2026.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 10537945Basen-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.
- Background: PubMed 19685367Humphreys 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.
- BackgroundScott, 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 dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca A Braun, DrPH, MPH principal investigator
ETR Associates
Pamela Anderson, PhD principal investigator
ETR Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yes and Know curriculum and Nutrition Education for Adolescents in people with Pregnancy Related and Sexually Transmitted Diseases, run by ETR Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The U.S. Department of Health and Human Services terminated funding for the study effective June 26, 2026.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of unprotected vaginal or anal sex (time frame: 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581536, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.