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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yes and Know curriculum | Experimental | Youth will receive the Yes and Know curriculum. |
|
| Nutrition Education for Adolescents | Active Comparator | Youth will receive education about adolescent nutrition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yes and Know curriculum | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
- Anyone not meeting inclusion criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca A Braun, DrPH, MPH | Contact | 510-858-0989 | rebecca.braun@etr.org | |
| Pamela K Anderson, PhD | Contact | 831-438-4060 | pamela.anderson@etr.org |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca A Braun, DrPH, MPH | ETR Associates | Principal Investigator |
| Pamela Anderson, PhD | ETR Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ETR Associates | Recruiting | Watsonville | California | 95076 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10537945 | Background | 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. | |
| 19685367 | Background | 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. |
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|
| Nutrition Education for Adolescents | Behavioral | 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. |
|
| 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 | 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). | 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). | 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). | 3 months post intervention |
| Background | 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. |
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C489834 | YES1 protein, human |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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