Evaluating the Many Ways of Being Program

Study Overview
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Brief Summary
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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.

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

Conditions
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Sexual Behavior, Unprotected Sex

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This research project will used an individual randomized controlled trial design in which youth at each intervention site will be randomized 1:1 into the experimental condition (Many Ways of Being) or the comparison condition (a career readiness program).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Many Ways of Being<br>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<br>* 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.<br>* Other names: Many Ways of Being;|
| Active Comparator: A career readiness program<br>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<br>* 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<br>|

What is the study measuring?
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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 |