NCT05801601

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

February 23, 2023

Last Update Submit

November 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • Sexual agency

    9 months following program completion

  • Knowledge related to healthy relationships

    Immediately post-program and 9 months following program completion

  • Knowledge related to sexual and reproductive health (measure 1)

    Immediately post-program and 9 months following program completion

  • Knowledge related to sexual and reproductive health (measure 2)

    Immediately post-program and 9 months following program completion

  • Knowledge related to sexual and reproductive health (measure 3)

    Immediately post-program and 9 months following program completion

  • +10 more secondary outcomes

Study Arms (2)

Many Ways of Being

EXPERIMENTAL

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

A career readiness program

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Many Ways of Being
Many Ways of Being

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

A career readiness program

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAYC's Teen Center

Washington D.C., District of Columbia, 20009, United States

RECRUITING

MeSH Terms

Conditions

Sexual BehaviorUnsafe Sex

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer Manlove, PhD

    Child Trends

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Manlove, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

April 6, 2023

Study Start

March 1, 2023

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations