MWB: Evaluating the Many Ways of Being Program

Sponsor
Child Trends (Other)
Overall Status
Recruiting
CT.gov ID
NCT05801601
Collaborator
Latin American Youth Center (Other), Equimundo:Center for Masculinities and Social Justice (Other), Family and Youth Services Bureau (Other)
700
2
2
32
350
10.9

Study Details

Study Description

Brief 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 eight-session Many Ways of Being program reduce unprotected sex (through consistent and correct use of condoms and contraceptives) compared to the Passport to Success 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 job readiness, Passport to Success.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships
  • Behavioral: Passport to Success
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 (Passport to Success).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 (Passport to Success).
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluating Many Ways of Being, an Innovative Gender-synchronized and Gender-transformative Sexual Health Program
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2025
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

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 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: Passport to Success

    In the comparison arm, International Youth Foundation's Passport to Success program will be implemented. Youth will receive eight sessions over four to eight weeks for a total of 14 hours and 40 minutes of programming.

    Behavioral: Passport to Success
    The Passport to Success program equips young people with a range of skills that will help them stay in school and acquire the education, professional skills, employment readiness and confidence they need to succeed in life and in the workplace.

    Outcome Measures

    Primary Outcome Measures

    1. Condomless sex (measure 1) [9 months following program completion]

      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".

    2. Unprotected vaginal sex (measure 2) [9 months following program completion]

      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".

    Secondary Outcome Measures

    1. Sexual agency [9 months following program completion]

      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)

    2. Knowledge related to healthy relationships [Immediately post-program and 9 months following program completion]

      Able to identify healthy and unhealthy relationship scenarios (% correct out of 7 items)

    3. Knowledge related to sexual and reproductive health (measure 1) [Immediately post-program and 9 months following program completion]

      Knowledge of contraceptive methods (% correct out of 4 items)

    4. Knowledge related to sexual and reproductive health (measure 2) [Immediately post-program and 9 months following program completion]

      Knowledge of STIs (% correct out of 5 items)

    5. Knowledge related to sexual and reproductive health (measure 3) [Immediately post-program and 9 months following program completion]

      Able to identify sexual consent (% correct out of 4 items)

    6. Intentions to practice sexual health promoting behaviors (measure 1) [Immediately post-program and 9 months following program completion]

      Intends to use contraception ("Yes, definitely") if chooses to have sex in the future

    7. Intentions to practice sexual health promoting behaviors (measure 2) [Immediately post-program and 9 months following program completion]

      Intends to use condoms ("Yes, definitely") if chooses to have sex in the future

    8. Intentions to practice sexual health promoting behaviors (measure 3) [Immediately post-program and 9 months following program completion]

      Intends to visit a health care provider for SRH services in the next 12 months (yes/no "Yes, definitely" vs other responses)

    9. Self-efficacy to practice sexual health promoting behaviors (measure 1) [Immediately post-program and 9 months following program completion]

      Know where to go to get birth control (yes/no "Yes, definitely" vs other responses)

    10. Self-efficacy to practice sexual health promoting behaviors (measure 2) [Immediately post-program and 9 months following program completion]

      Know where to go to get STI testing/ treatment (yes/no "Yes, definitely" versus other responses)

    11. Self-efficacy to practice sexual health promoting behaviors (measure 3) [Immediately post-program and 9 months following program completion]

      Level of comfort going to a provider for services or approaching a trusted adult for information about SRH (4-item Likert scale).

    12. Self-efficacy to practice sexual health promoting behaviors (measure 4) [Immediately post-program and 9 months following program completion]

      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.

    13. Positive attitudes around gender [Immediately post-program and 9 months following program completion]

      Gender-equitable attitudes scale (7-item Likert scale)

    14. Positive attitudes around sexual health (measure 1) [Immediately post-program and 9 months following program completion]

      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.

    15. Positive attitudes around sexual health (measure 2) [Immediately post-program and 9 months following program completion]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Latin American youth center 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Latin American Youth Center's Teen Center Washington District of Columbia United States 20009
    2 Paul Public Charter School Washington District of Columbia United States 20011

    Sponsors and Collaborators

    • Child Trends
    • Latin American Youth Center
    • Equimundo:Center for Masculinities and Social Justice
    • Family and Youth Services Bureau

    Investigators

    • Principal Investigator: Jennifer Manlove, PhD, Child Trends

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Child Trends
    ClinicalTrials.gov Identifier:
    NCT05801601
    Other Study ID Numbers:
    • 90AP2693
    First Posted:
    Apr 6, 2023
    Last Update Posted:
    Apr 6, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 6, 2023