Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men

NCT06443541 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3439

Last updated 2025-08-05

No results posted yet for this study

Summary

This project, SCALE, will be the first to compare lower-intensity (standard) and higher-intensity implementation strategies to deliver GlobalConsent-an efficacious web-based sexual violence prevention program-to men attending seven universities across Vietnam. Following a rigorous, mixed-methods, comparative interrupted-time-series design, researchers will collect novel data to compare implementation fidelity, drivers and outcomes, effectiveness, and cost-effectiveness across implementation strategy groups. This partnership includes universities also engaged in a violence-prevention training grant (D43TW012188), offering an unparalleled opportunity for capacity strengthening and evidence generation to guide national leaders on the best strategies for launching GlobalConsent at scale, addressing a sex-differentiated risk factor in adolescence, and thereby improving a range of health outcomes into adulthood.

Conditions

  • Violence, Sexual

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

OTHER

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)

OTHER

Low-intensity implementation strategies (LIS) for Faculty

Passive access to web-based educational materials

OTHER

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)

OTHER

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

OTHER

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

OTHER

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Center for Creative Initiatives in Health and Population

    collaborator OTHER
  • Georgia State University

    collaborator OTHER
  • Emory University

    lead OTHER

Principal Investigators

  • Kathryn Yount, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443541 on ClinicalTrials.gov