Yes and Know Curriculum for Sexually Transmitted Infections

(Yes and Know Trial)

Overseen By Karin K Coyle, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: ETR Associates

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 9 weeks

1200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Yes and Know treatment for sexually transmitted infections?

The research shows that educational programs about sexually transmitted infections can improve knowledge and attitudes among healthcare providers, which may indirectly support the effectiveness of the Yes and Know treatment by ensuring better-informed care. ^{1 2 3 4 5}

Is the Yes and Know Curriculum for Sexually Transmitted Infections safe for participants?

The available research does not provide specific safety data for the Yes and Know Curriculum, as it focuses on educational outcomes rather than safety concerns. ^{6 7 8 9 10}

What is the purpose of 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.

Research Team

Karin K Coyle, PhD

Principal Investigator

ETR Associates

Rebecca A Braun, DrPH, MPH

Principal Investigator

ETR Associates

Eligibility Criteria

This trial is for English-speaking youth aged 14-19 who are interested in learning about sexual health and well-being. It's designed to see if the Yes and Know program can help reduce unprotected sex and improve knowledge of reproductive health, self-efficacy, and use of health services.

Inclusion Criteria

English speaking

I am between 14 and 19 years old.

Exclusion Criteria

Anyone not meeting inclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Yes and Know or Nutrition Skills program through nine 60-minute synchronous virtual sessions, along with asynchronous online activities and resources

9 weeks

9 virtual sessions

Follow-up

Participants complete online surveys to assess the program's effectiveness in reducing unprotected sex and improving health knowledge and self-efficacy

12 months

Online surveys at 3 and 12 months post-intervention

Treatment Details

Interventions

• Yes and Know

Trial Overview The study compares two educational programs: 'Yes and Know', focusing on sexual health, delivered virtually over nine hours plus online activities; versus a nutrition education program. The effectiveness will be measured through surveys before, three months after, and one year after the sessions.

Participant Groups

Group I: Yes and Know curriculum Experimental Treatment 1 Intervention

Youth will receive the Yes and Know curriculum.

Group II: Nutrition Education for Adolescents Active Control 1 Intervention

Youth will receive education about adolescent nutrition.

Who Is Running the Clinical Trial?

ETR Associates

Lead Sponsor

Trials

14

Recruited

12,900+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a sexually transmitted diseases training program. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Impact on practice of a British Association for Sexual Health and HIV Sexually Transmitted Infections Foundation (STIF) course: an audit of the first four years in Ireland. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Emergency care of urban women with sexually transmitted infections: time to address deficiencies. [2019]

4. Scotland pubmed.ncbi.nlm.nih.gov

The knowledge and attitudes of student nurses towards patients with sexually transmitted infections: exploring changes to the curriculum. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an individual, online e-learning program about sexually transmitted infections: a prospective cohort study. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The effectiveness of an extra-curricular lecture for STI prevention and sexual education. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Sexually Transmitted Infections Among Men and Transgender Women Using HIV Pre-exposure Prophylaxis in a Large Integrated Health System-A Cohort Study. [2023]

8. Sweden pubmed.ncbi.nlm.nih.gov

Changes in sexual behaviour focusing on condom use in STD clinic attenders in Göteborg, Sweden, from 1989 to 1994--a questionnaire survey. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Developing sexually transmitted disease guidelines in the USA and the UK. [2016]

10. South Africa pubmed.ncbi.nlm.nih.gov

Patients with sexually transmitted diseases at the Alexandra Health Centre and University Clinic. [2014]