Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
NCT ID: NCT06443541
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
3439 participants
INTERVENTIONAL
2024-03-27
2028-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preventing Sexual Violence in College Men: RealConsent for Use in Vietnam
NCT04147455
Enhancing School-Based Violence Prevention
NCT04087772
The Economics of Domestic Violence: Evidence From Bangladesh
NCT06916377
How do Adults Sexual Offender Against Pre-pubescent Minors Perceive the Notion of Consent Based on the Account of Their Lived Experience ? (SOconsent)
NCT07035717
Using Media to Shift Social Norms of Violence Among Youth
NCT02706145
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The researchers will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Proctor et al. frameworks and a mixed-methods, comparative interrupted time series (CITS) design to compare implementation; implementation drivers and outcomes; implementation effectiveness; and cost-effectiveness of lower-intensity vs higher-intensity (LIS; HIS) implementation strategies to deliver GlobalConsent.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Students
Students in either randomization group will become active consumers of GlobalConsent with an email introduction to the program, process, delivery schedule, data collection procedures, and consent.
High-intensity implementation strategies (HIS)-Students
Students in the HIS group will receive educational outreach in a pre-implementation in-person orientation to GlobalConsent, covering similar topics and three monthly one-hour learning sessions during implementation in which technical questions about program access or progression can be addressed; more intensive intervention to enhance adherence with more frequent email/Short Message Service (SMS), completion reminders; and demand generation encouraging program completion.
Low-intensity implementation strategies (LIS) for Students
Students in the LIS group will receive basic implementation strategies of the GlobalConsent often used to deliver online programs at US universities with email/SMS completion reminders with a predetermined frequency for 12 weeks.
Faculty
Faculty will receive access to educational material based on the university randomization implementation strategies group.
High-intensity implementation strategies (HIS) for Faculty
* Passive access to web-based educational materials
* Town halls (3) with general faculty to define sexual violence; rates in young people; acute/chronic effects over the life course; primary-prevention evidence-based interventions (EBIs)
Low-intensity implementation strategies (LIS) for Faculty
Passive access to web-based educational materials
Leaders
Leaders will receive site-specific (University) invitations and material based on the implementation strategies group.
High-intensity implementation strategies (HIS) for Leaders
* Site-specific invitation to participate
* Passive access to web-based educational materials
* One pre-implementation webinar to define sexual violence; rates among young people in Vietnam; acute/chronic effects over life course; primary-prevention EBIs; recap of project description and collaboration; share GlobalConsent website for passive access to educational materials
* Monthly emails from trained internal facilitators to university leaders with updates on implementation progress
* One post-implementation webinar to share anonymized findings (by IS group); discuss plan for sustainment (including guidance on how to handle reporting of sexual violence in existing university counseling centers)
Low-intensity implementation strategies (LIS) for Leaders
* Site-specific invitation to participate
* Passive access to web-based educational materials
* One pre-implementation webinar to define sexual violence; rates among young people in Vietnam; acute/chronic effects over life course; primary-prevention EBIs; recap of project description and collaboration; share GlobalConsent website for passive access to educational materials
Implementation Team Members
Implementation team members will receive passive access to web-based materials and training according to the university-specific implementation strategies group.
High-intensity implementation strategies (HIS) for Implementation Team Members
* Passive access to web-based educational materials
* In-person technical training on campus-wide implementation of GlobalConsent; discussion and demonstration of GlobalConsent program; standardized implementation manual
* In-person leadership training to champion GlobalConsent with internal stakeholders (leaders, implementation teams, faculty, students); leadership styles; managing teams; influence without authority; managing conflict; emotional intelligence; negotiation; leading change
* Biweekly (six) 1-hr recorded quality-improvement team webinars to provide refresher training; assess implementation progress; assess modifications; build peer-network; provide anonymized data on implementation progress for discussion
Low-intensity implementation strategies (LIS) Implementation Team Members
* Passive access to web-based educational materials
* In-person technical training on campus-wide implementation of GlobalConsent; discussion and demonstration of GlobalConsent program; standardized implementation manual
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High-intensity implementation strategies (HIS)-Students
Students in the HIS group will receive educational outreach in a pre-implementation in-person orientation to GlobalConsent, covering similar topics and three monthly one-hour learning sessions during implementation in which technical questions about program access or progression can be addressed; more intensive intervention to enhance adherence with more frequent email/Short Message Service (SMS), completion reminders; and demand generation encouraging program completion.
Low-intensity implementation strategies (LIS) for Students
Students in the LIS group will receive basic implementation strategies of the GlobalConsent often used to deliver online programs at US universities with email/SMS completion reminders with a predetermined frequency for 12 weeks.
High-intensity implementation strategies (HIS) for Faculty
* Passive access to web-based educational materials
* Town halls (3) with general faculty to define sexual violence; rates in young people; acute/chronic effects over the life course; primary-prevention evidence-based interventions (EBIs)
Low-intensity implementation strategies (LIS) for Faculty
Passive access to web-based educational materials
High-intensity implementation strategies (HIS) for Leaders
* Site-specific invitation to participate
* Passive access to web-based educational materials
* One pre-implementation webinar to define sexual violence; rates among young people in Vietnam; acute/chronic effects over life course; primary-prevention EBIs; recap of project description and collaboration; share GlobalConsent website for passive access to educational materials
* Monthly emails from trained internal facilitators to university leaders with updates on implementation progress
* One post-implementation webinar to share anonymized findings (by IS group); discuss plan for sustainment (including guidance on how to handle reporting of sexual violence in existing university counseling centers)
Low-intensity implementation strategies (LIS) for Leaders
* Site-specific invitation to participate
* Passive access to web-based educational materials
* One pre-implementation webinar to define sexual violence; rates among young people in Vietnam; acute/chronic effects over life course; primary-prevention EBIs; recap of project description and collaboration; share GlobalConsent website for passive access to educational materials
High-intensity implementation strategies (HIS) for Implementation Team Members
* Passive access to web-based educational materials
* In-person technical training on campus-wide implementation of GlobalConsent; discussion and demonstration of GlobalConsent program; standardized implementation manual
* In-person leadership training to champion GlobalConsent with internal stakeholders (leaders, implementation teams, faculty, students); leadership styles; managing teams; influence without authority; managing conflict; emotional intelligence; negotiation; leading change
* Biweekly (six) 1-hr recorded quality-improvement team webinars to provide refresher training; assess implementation progress; assess modifications; build peer-network; provide anonymized data on implementation progress for discussion
Low-intensity implementation strategies (LIS) Implementation Team Members
* Passive access to web-based educational materials
* In-person technical training on campus-wide implementation of GlobalConsent; discussion and demonstration of GlobalConsent program; standardized implementation manual
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Men who self-identify as heterosexual or bisexual (who are attracted to women),
* Enrolled as first-year students in any of the seven participating study universities in North, Central, and South Vietnam.
* All registered lecturers at each of the seven participating study universities will be eligible to participate in the faculty surveys in years 1, 3, and 5.
* Recommendation of study staff at each participating study university
* Knowledge about the implementation landscape and implementation of GlobalConsent.
* Identified by relevant study staff.
Exclusion Criteria
* Individuals who are not yet adults (infants, children, teenagers)
* None
* None
* None
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Center for Creative Initiatives in Health and Population
OTHER
Georgia State University
OTHER
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kathryn Yount
Professor of Global Health
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathryn Yount, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Can Tho University of Medicine and Pharmacy (CTUMP)
Can Tho, , Vietnam
Da Nang University of Medical Technology & Pharmacy (DUMTP)
Da Nang, , Vietnam
Hai Phong University of Medicine and Pharmacy
Haiphong, , Vietnam
Hanoi Medical University
Hanoi, , Vietnam
Ho Chi Minh City Medicine and Pharmacy University
Ho Chi Minh City, , Vietnam
Hong Bang University
Ho Chi Minh City, , Vietnam
Hue University of Medicine and Pharmacy
Huế, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Tran Hung Minh, MD, MSc
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Yount KM, Whitaker D, Fang X, Trang QT, Macaulay M, Hung MT. Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): Study Protocol for a National Implementation Trial. Res Sq [Preprint]. 2024 Sep 10:rs.3.rs-4745916. doi: 10.21203/rs.3.rs-4745916/v1.
Yount KM, Whitaker DJ, Fang X, Trang QT, Macaulay M, Minh TH. Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): study protocol for a national implementation trial. Trials. 2024 Aug 29;25(1):571. doi: 10.1186/s13063-024-08401-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00006481
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.