Evaluating the Many Ways of Being Program

Sexual Behavior Clinical Trial

— MWB  

Official title:

Evaluating Many Ways of Being, an Innovative Gender-synchronized and Gender-transformative Sexual Health Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801601
• Other study ID #: 90AP2693
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: November 2023
• Source: Child Trends
• Contact: Jennifer Manlove, PhD
• Phone: 240-223-9262
• Email: jmanlove[@]childtrends.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized control trial is to clinical trial is to evaluate Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships.

The overall goal of the MWB program is to reduce incidence of sexually transmitted infections (STI) and unplanned pregnancy and promote healthy, consensual, and violence-free relationships among youth. The primary research question we aim to answer through this study is: Among youth ages 15-19, does the Many Ways of Being program reduce unprotected sex (through consistent and correct use of condoms and contraceptives) compared to the a career readiness program, which does not include sexual health components?

As part of the study, participants will be asked to:

• Attend approximately 14 hours and 40 minutes of programming completed over 4-8 weeks

• Complete baseline, post-intervention, and 9-month follow-up surveys

• For select participants who received the MWB program, participate in an optional focus group discussion

The local evaluation will focus on the impact of the entire MWB intervention, as compared to a similar-length control program focused on career readiness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• Youth age 15-19 in the greater Metropolitan DC area

Exclusion Criteria:

• Youth who are actively planning a pregnancy, have participated in the other sexual health programming through the LAYC previously, or are receiving other sexual health education during the implementation period. Youth who do not speak English and/or Spanish will also not be eligible to participate.

Related Conditions & MeSH terms

• Sexual Behavior
• Unprotected Sex

Intervention

Behavioral:
• Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships
The Many Ways of Being program is a gender-synchronous program informed by Equimundo's existing single-gender Manhood 2.0 and Sisterhood 2.0 programs. The curriculum is designed to shift unequal gender attitudes and behaviors and provide skill-building on maintaining healthy relationships, making healthy and informed decisions around sex, and avoiding risky sexual behaviors.
• A career readiness program
Youth enrolled in the control condition will receive a career readiness curriculum, either International Youth Foundation's Passport to Success, LAYC's Next Generation program or LAYC's Career Readiness Curriculum, depending on the site and implementation period. These programs equip young people with a range of professional, employment readiness, and practical skills that will help them stay in school and acquire the education, professional skills, employment

Locations

Country	Name	City	State
United States	LAYC's Teen Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Child Trends	Equimundo:Center for Masculinities and Social Justice, Family and Youth Services Bureau, Latin American Youth Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condomless sex (measure 1)	Vaginal or anal sex without a condom in the past 3 months (yes/no). Yes if had vaginal or anal sex in the past 3 months and did not use a condom "all the time". No if did not have sex or used a condom "all the time".	9 months following program completion
Primary	Unprotected vaginal sex (measure 2)	Vaginal sex without any contraception (including condom) in the past 3 months (yes/no) Yes if had sex in the past 3 months and did not use a contraceptive "all the time". No if did not have sex or used a contraceptive "all the time".	9 months following program completion
Secondary	Sexual agency	The respondent reported that they communicated what they "liked, disliked, or wanted to try" "all" or "most" of the time and that they asked what their partner "liked, disliked, or wanted to try" "all" or "most" of the time when participating in any sexual activity (including sexual touching) in the past 3 months OR respondent was not sexually active in the past 3 months. (yes/no)	9 months following program completion
Secondary	Knowledge related to healthy relationships	Able to identify healthy and unhealthy relationship scenarios (% correct out of 7 items)	Immediately post-program and 9 months following program completion
Secondary	Knowledge related to sexual and reproductive health (measure 1)	Knowledge of contraceptive methods (% correct out of 4 items)	Immediately post-program and 9 months following program completion
Secondary	Knowledge related to sexual and reproductive health (measure 2)	Knowledge of STIs (% correct out of 5 items)	Immediately post-program and 9 months following program completion
Secondary	Knowledge related to sexual and reproductive health (measure 3)	Able to identify sexual consent (% correct out of 4 items)	Immediately post-program and 9 months following program completion
Secondary	Intentions to practice sexual health promoting behaviors (measure 1)	Intends to use contraception ("Yes, definitely") if chooses to have sex in the future	Immediately post-program and 9 months following program completion
Secondary	Intentions to practice sexual health promoting behaviors (measure 2)	Intends to use condoms ("Yes, definitely") if chooses to have sex in the future	Immediately post-program and 9 months following program completion
Secondary	Intentions to practice sexual health promoting behaviors (measure 3)	Intends to visit a health care provider for SRH services in the next 12 months (yes/no "Yes, definitely" vs other responses)	Immediately post-program and 9 months following program completion
Secondary	Self-efficacy to practice sexual health promoting behaviors (measure 1)	Know where to go to get birth control (yes/no "Yes, definitely" vs other responses)	Immediately post-program and 9 months following program completion
Secondary	Self-efficacy to practice sexual health promoting behaviors (measure 2)	Know where to go to get STI testing/ treatment (yes/no "Yes, definitely" versus other responses)	Immediately post-program and 9 months following program completion
Secondary	Self-efficacy to practice sexual health promoting behaviors (measure 3)	Level of comfort going to a provider for services or approaching a trusted adult for information about SRH (4-item Likert scale).	Immediately post-program and 9 months following program completion
Secondary	Self-efficacy to practice sexual health promoting behaviors (measure 4)	Self-reported ability to communicate with partners about consent, sex, and contraception (5-item Likert scale). Three items draw from Upadhyay UD et al. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94.	Immediately post-program and 9 months following program completion
Secondary	Positive attitudes around gender	Gender-equitable attitudes scale (7-item Likert scale)	Immediately post-program and 9 months following program completion
Secondary	Positive attitudes around sexual health (measure 1)	Self-love subscale from Sexual and Reproductive Empowerment Scale (4-item Likert scale). Citation: Upadhyay UD et al. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94.	Immediately post-program and 9 months following program completion
Secondary	Positive attitudes around sexual health (measure 2)	Sexual pleasure subscale from Sexual Reproductive Empowerment Scale (3-item Likert scale). Citation: Upadhyay UD et al. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94.	Immediately post-program and 9 months following program completion