Recruiting

Observational Study

Sponsor:

Child Trends

Code:

NCT05801601

Conditions

Sexual Behavior

Unprotected Sex

Eligibility Criteria

Sex: All

Age: 15 - 19

Healthy Volunteers: Not accepted

Interventions

Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships

A career readiness program

Study Details

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.

Conditions

Sexual Behavior

Unprotected Sex

Study ID

NCT05801601

Start date

Mar 1, 2023

Status verified date

Nov, 2023

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 19

Healthy Volunteers: Not accepted

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 Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Condomless sex (measure 1) [ Time Frame: 9 months following program completion ]
  • Unprotected vaginal sex (measure 2) [ Time Frame: 9 months following program completion ]

Central Contacts and Locations

Central contacts

Jennifer Manlove, PhD

240-223-9262jmanlove@childtrends.org

Locations

LAYC's Teen Center

Recruiting

Washington, District of Columbia, United States, 20009

More Information

Sponsor

Child Trends

Last update posted

Nov 21, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Child Trends on 2023-11-21.