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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04962802
Other study ID # 5U01DP006129
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date July 31, 2018

Study information

Verified date July 2021
Source Child Trends
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 18 Years
Eligibility Inclusion Criteria: - Male - Ages 15-18 - Able to participate in a program delivered only in English Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Manhood 2.0
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.
Post-High School Readiness
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.

Locations

Country Name City State
United States Latin American Youth Center Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
Child Trends Latin American Youth Center, Promundo, United States

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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