Evaluating the Many Ways of Being Program (MWB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sexual Behavior; Unprotected Sex
• Intervention / Treatment: Behavioral: Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships; Behavioral: A career readiness program

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Manlove, PhD; Phone Number: 240-223-9262; Email: jmanlove@childtrends.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • Recruiting
      • LAYC's Teen Center
      • Contact: Lauren LaPointe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Many Ways of Being; In the experimental arm, Equimundo's Many Ways of Being program will be implemented. Youth will receive eight two-hour sessions or 16 one-hour sessions over four to eight weeks for a total of 14 hours and 40 minutes of programming.	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.; Other Names: Many Ways of Being
Active Comparator: A career readiness program; In the comparison arm, a curriculum focused on career readiness will be implemented. Youth will receive eight two-hour sessions or 16 one-hour sessions over four to eight weeks for a total of 14 hours and 40 minutes of programming.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
Positive attitudes around gender	Gender-equitable attitudes scale (7-item Likert scale)	Immediately post-program and 9 months following program completion
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
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

Collaborators and Investigators

• Sponsor: Child Trends
• Collaborators: Family and Youth Services Bureau; Latin American Youth Center; Equimundo:Center for Masculinities and Social Justice
• Investigators: Principal Investigator: Jennifer Manlove, PhD, Child Trends

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 90AP2693

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No