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Clinical Trials/NCT05801601
NCT05801601RecruitingNot Applicable

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

Child Trends1 site in 1 country700 target enrollmentStarted: March 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
700
Locations
1
Primary Endpoint
Condomless sex (measure 1)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
15 Years to 19 Years (Child, Adult)
Sex
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 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.

Arms & Interventions

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.

Intervention: 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

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.

Intervention: A career readiness program (Behavioral)

Outcomes

Primary Outcomes

Condomless sex (measure 1)

Time Frame: 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".

Unprotected vaginal sex (measure 2)

Time Frame: 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 Outcomes

  • Positive attitudes around sexual health (measure 2)(Immediately post-program and 9 months following program completion)
  • Knowledge related to healthy relationships(Immediately post-program and 9 months following program completion)
  • Intentions to practice sexual health promoting behaviors (measure 1)(Immediately post-program and 9 months following program completion)
  • Positive attitudes around sexual health (measure 1)(Immediately post-program and 9 months following program completion)
  • Sexual agency(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)
  • Intentions to practice sexual health promoting behaviors (measure 2)(Immediately post-program and 9 months following program completion)
  • Intentions to practice sexual health promoting behaviors (measure 3)(Immediately post-program and 9 months following program completion)
  • Self-efficacy to practice sexual health promoting behaviors (measure 1)(Immediately post-program and 9 months following program completion)
  • Self-efficacy to practice sexual health promoting behaviors (measure 4)(Immediately post-program and 9 months following program completion)
  • Positive attitudes around gender(Immediately post-program and 9 months following program completion)
  • Self-efficacy to practice sexual health promoting behaviors (measure 2)(Immediately post-program and 9 months following program completion)
  • Self-efficacy to practice sexual health promoting behaviors (measure 3)(Immediately post-program and 9 months following program completion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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