Clinical trial NCT06581536: Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Sexually Transmitted Diseases
Adolescent Behavior
Lead sponsor: ETR Associates
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2024-09-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: For the Yes and Know study, cohorts of 5-15 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. Each cohort will be recruited from a local partner site (with a focus on rural communities in the South and Southeast regions of the United States), and 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 sites' scheduling).

Eligibility criteria: Inclusion Criteria:

* Ages 14-19; and
* English speaking.

Exclusion Criteria:

- Anyone not meeting inclusion criteria.

Primary outcomes:
measure: Rates of unprotected vaginal or anal sex
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Use of sexual and reproductive health services in the past 3 months
timeFrame: 12 months post intervention
measure: Sexual and reproductive health knowledge
timeFrame: 3 months post intervention
measure: Positive attitudes towards sexual consent
timeFrame: 3 months post intervention
measure: Self-efficacy in relationship communication
timeFrame: 3 months post intervention
measure: Self-efficacy in using condoms correctly
timeFrame: 3 months post intervention
Other outcomes:
Locations:
city: Watsonville
country: United States
facility: ETR Associates
state: California
Study officials:
affiliation: ETR Associates
name: Rebecca A Braun, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: ETR Associates
name: Karin K Coyle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.