Sexual BehaviorNCT04962802
Evaluation of Manhood 2.0: A Community-Based Teen Pregnancy Prevention Program for Young Men
A study testing Manhood 2.0 and Post-High School Readiness in people with Sexual Behavior and Unprotected Sex, run by Child Trends at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Unprotected Sex
- What is being tested?
- Manhood 2.0 and Post-High School Readiness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male
- Ages 15-18
- Able to participate in a program delivered only in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Latin American Youth Center
Washington D.C., District of Columbia, 20009
About this study
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.
- Conditions
- Sexual Behavior, Unprotected Sex
- Being tested
- Manhood 2.0, Post-High School Readiness
- Medical subject headings
- Sexual Behavior, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manhood 2.0Behavioural
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 ReadinessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Post-High School Readiness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected sex
Number of participants who reporting having vaginal sex in the past month without using a condom or other contraceptive method.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4.5 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Nov 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Child Trends
- Sponsor type
- University, hospital or other
- Collaborators
- Promundo, United States, Latin American Youth Center
- Responsible party
- Principal investigator, Jennifer Manlove, Child Trends
- Investigators
- Jennifer Manlove, PhD, Principal investigator, Child Trends
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962802
- Sponsor's protocol ID
- 5U01DP006129
- Status last verified
- Jul 2021
- First submitted
- 10 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Manhood 2.0: A Community-Based Teen Pregnancy Prevention Program for Young Men
- ClinicalTrials.gov ID
- NCT04962802
- Acronym / sponsor ID
- 5U01DP006129
- Conditions
- Sexual Behavior, Unprotected Sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Child TrendsUniversity, hospital or other
- Collaborators
- Promundo, United States, Latin American Youth Center
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manhood 2.0 | Experimental | Behavioral: Manhood 2.0Manhood 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. |
| Post-High School Readiness | Placebo comparator | Behavioral: Post-High School ReadinessThe 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. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male
- Ages 15-18
- Able to participate in a program delivered only in English
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manhood 2.0Manhood 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. | Behavioural | Manhood 2.0 |
| Post-High School ReadinessPost-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. | Behavioural | Post-High School Readiness |
Primary outcome
Unprotected sex
Time frame: 1.5 months after baseline
Number of participants who reporting having vaginal sex in the past month without using a condom or other contraceptive method.
Unprotected sex
Time frame: 4.5 months after baseline
Number of participants who reporting having vaginal sex in the past month without using a condom or other contraceptive method.
Sex without a condom
Time frame: 1.5 months after baseline
Number of participants who reporting having vaginal sex in the past month without using a condom.
Sex without a condom
Time frame: 4.5 months after baseline
Number of participants who reporting having vaginal sex in the past month without using a condom.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Manlove, PhD principal investigator
Child Trends
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manhood 2.0 and Post-High School Readiness in people with Sexual Behavior and Unprotected Sex, run by Child Trends at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unprotected sex (time frame: 1.5 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.