NCT04962802

Brief Summary

Manhood 2.0 is a male-only group-level intervention, delivered over 13 hours, based on social cognitive theory, social norm theory, theory of gender and power, and the theory of reasoned action. The intervention is a gender-transformative program that promotes critical reflection and awareness on reproductive health, healthy relationships, gender norms and stereotypes that drive reproductive health behavior, and explicit and proactive support of female partner contraceptive use. Activities include group discussion, role playing, knowledge sharing, and skill-building; their purpose is to challenge young men to think critically about social expectations and restrictive norms, engage in dialogue about these gender norms, and then assess the way rigid norms affect their attitudes and behaviors toward a number of key issues, including intimate relationships, gender-based violence, substance abuse, sexually transmitted infections, and early pregnancy. Young men receive the intervention at a local community center or high school. Comparison condition young men receive a post-high school readiness program that does not discuss gender norms or sexual and reproductive health. The study was conducted with six cohorts of eligible young men ages 15-18 who received a baseline, immediate post-intervention, and three-month post-intervention survey. To participate in the study, individuals had to meet all the following criteria: (1) Identify as male; (2) Ages 15 to 18; (3) Not actively planning a pregnancy with someone; (4) Never participated in the community center's sexual and reproductive health program; (5) Received no additional sexual or reproductive health programming in the last three months; (6) Able to participate in a program delivered in English only. The investigators hypothesized that Manhood 2.0 participants would have lower rates of unprotected sex and more equitable attitudes towards gender than comparison participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

July 10, 2021

Last Update Submit

July 21, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Unprotected sex

    Number of participants who reporting having vaginal sex in the past month without using a condom or other contraceptive method.

    1.5 months after baseline

  • Unprotected sex

    Number of participants who reporting having vaginal sex in the past month without using a condom or other contraceptive method.

    4.5 months after baseline

  • Sex without a condom

    Number of participants who reporting having vaginal sex in the past month without using a condom.

    1.5 months after baseline

  • Sex without a condom

    Number of participants who reporting having vaginal sex in the past month without using a condom.

    4.5 months after baseline

Study Arms (2)

Manhood 2.0

EXPERIMENTAL

Manhood 2.0 is a group-level intervention, delivered in 7 sessions over 13 hours, and is based on social cognitive theory, social norm theory, theory of gender and power, and the theory of reasoned action. Sessions were delivered twice a week, for approximately 3.5 weeks. For the final session, participants received one hour of content and were administered the immediate post-intervention survey. The intervention takes a holistic, gender-transformative approach, includes reproductive health knowledge, healthy relationships, altering gender norms and stereotypes which drive reproductive health behavior, and explicit and proactive support of female partner contraceptive use. Activities are designed to engage young men in critical reflection and dialogue about gender norms, and then apply these discussions to a range of key issues including intimate relationships, gender-based violence, substance abuse, STIs, and early pregnancy.

Behavioral: Manhood 2.0

Post-High School Readiness

PLACEBO COMPARATOR

The Post-High School Readiness Program helped youth build skills around identifying colleges or programs of interest, completing applications for programs, writing resumes and increasing financial literacy. The post-high school readiness curriculum was delivered by LAYC staff members and the content was delivered twice a week, for approximately 3.5 weeks (as with the intervention). For the final session, participants did not receive content and were administered the immediate post-intervention survey.

Behavioral: Post-High School Readiness

Interventions

Manhood 2.0BEHAVIORAL

Manhood 2.0 engages young men in questioning, challenging, and transforming harmful gender norms, with the goal of reducing intimate partner and sexual violence and unintended teen pregnancy. Manhood 2.0 is a male-only group-level intervention, based on social cognitive theory, social norm theory, theory of gender and power, and the theory of reasoned action. Activities include group discussion, role playing, knowledge sharing, and skill-building; their purpose is to challenge young men to think critically about social expectations and restrictive norms, engage in dialogue about these gender norms, and then assess the way rigid norms affect their attitudes and behaviors toward key issues, including intimate relationships, gender-based violence, substance abuse, sexually transmitted infections, and early pregnancy. Sessions are two hours long and occur once a week for seven weeks.

Manhood 2.0

Post-High School Readiness program helps young men prepare for life after high school. This includes helping them prepare resumes, learning how to apply to jobs or colleges, providing interview prep, and other life skills. It is a male-only group-level program that includes discussion, feedback, knowledge sharing, and skill-building; their purpose is to prepare young men for life after high school. Sessions are two hours long and occur once a week for seven weeks.

Post-High School Readiness

Eligibility Criteria

Age15 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male
  • Ages 15-18
  • Able to participate in a program delivered only in English

You may not qualify if:

  • Actively planning a pregnancy with someone
  • Received sexual and reproductive health programming in the last 3 months
  • Ever participated in the intervention site's sexual and reproductive health program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Latin American Youth Center

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

Location

MeSH Terms

Conditions

Sexual BehaviorUnsafe Sex

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer Manlove, PhD

    Child Trends

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Program Area Director

Study Record Dates

First Submitted

July 10, 2021

First Posted

July 15, 2021

Study Start

November 1, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations