Clinical trial NCT05801601: Evaluating the Many Ways of Being Program
Official title: Evaluating Many Ways of Being, an Innovative Gender-synchronized and Gender-transformative Sexual Health Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Behavior
Unprotected Sex
Lead sponsor: Child Trends
Sponsor class: OTHER
Collaborators: name: Latin American Youth Center
name: Equimundo:Center for Masculinities and Social Justice
name: Family and Youth Services Bureau
First posted: 2023-04-06
Enrollment: 700
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 (a career readiness program).
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Condomless sex (measure 1)
timeFrame: 9 months following program completion
measure: Unprotected vaginal sex (measure 2)
timeFrame: 9 months following program completion
Secondary outcomes:
measure: Sexual agency
timeFrame: 9 months following program completion
measure: Knowledge related to healthy relationships
timeFrame: Immediately post-program and 9 months following program completion
measure: Knowledge related to sexual and reproductive health (measure 1)
timeFrame: Immediately post-program and 9 months following program completion
measure: Knowledge related to sexual and reproductive health (measure 2)
timeFrame: Immediately post-program and 9 months following program completion
measure: Knowledge related to sexual and reproductive health (measure 3)
timeFrame: Immediately post-program and 9 months following program completion
measure: Intentions to practice sexual health promoting behaviors (measure 1)
timeFrame: Immediately post-program and 9 months following program completion
measure: Intentions to practice sexual health promoting behaviors (measure 2)
timeFrame: Immediately post-program and 9 months following program completion
measure: Intentions to practice sexual health promoting behaviors (measure 3)
timeFrame: Immediately post-program and 9 months following program completion
measure: Self-efficacy to practice sexual health promoting behaviors (measure 1)
timeFrame: Immediately post-program and 9 months following program completion
measure: Self-efficacy to practice sexual health promoting behaviors (measure 2)
timeFrame: Immediately post-program and 9 months following program completion
measure: Self-efficacy to practice sexual health promoting behaviors (measure 3)
timeFrame: Immediately post-program and 9 months following program completion
measure: Self-efficacy to practice sexual health promoting behaviors (measure 4)
timeFrame: Immediately post-program and 9 months following program completion
measure: Positive attitudes around gender
timeFrame: Immediately post-program and 9 months following program completion
measure: Positive attitudes around sexual health (measure 1)
timeFrame: Immediately post-program and 9 months following program completion
measure: Positive attitudes around sexual health (measure 2)
timeFrame: Immediately post-program and 9 months following program completion
Other outcomes:
Locations:
city: Washington
country: United States
facility: LAYC's Teen Center
state: District of Columbia
Study officials:
affiliation: Child Trends
name: Jennifer Manlove, PhD
role: PRINCIPAL_INVESTIGATOR
References: