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

ETR Associates

Status: Enrolling

Conditions: Sexually Transmitted Diseases; Pregnancy Related; Adolescent Behavior

Treatments: Behavioral: Nutrition Education for Adolescents; Behavioral: Yes and Know curriculum

Study type: Interventional

Funder types: Other

Identifiers

NCT06581536

TP2AH000079

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,200 estimated patients

Sex: All

Ages: 14 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 14-19; and
• English speaking.

Exclusion criteria

• Anyone not meeting inclusion criteria.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Yes and Know curriculum

Experimental group

Description:

Youth will receive the Yes and Know curriculum.

Treatment:

Behavioral: Yes and Know curriculum

Nutrition Education for Adolescents

Active Comparator group

Description:

Youth will receive education about adolescent nutrition.

Treatment:

Behavioral: Nutrition Education for Adolescents