NCT06443541

Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men

SCALE: Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,439 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Sexual violence is prevalent in adolescence and heightens the risk of harmful long-term health effects. Sexual violence includes any sexual act committed against a person without freely given consent. All sexes may experience sexual violence, but sexual violence more often burdens women than men globally, and men most often perpetrate such violence. Adolescence is a period of vulnerability to sexual violence, with about one in five college women in the US experiencing a campus sexual assault, and 91% of victims being women. Less is known about the rates of sexual violence on college campuses. Still, estimates from large, multi-country surveys confirm that young men's reported sexually violent behavior and young women's reported sexual violence victimization are high, including in Asia/Pacific. In Vietnam, from 2010 to 2019, women's reports of lifetime sexual violence by a partner increased (10% to 13%), especially in women 18-24 years (5% to 14%). Such trends may reflect changing exposure and more openness to discuss sex and sexual violence. Also, nearly one in ten women (9%) report non-partner sexual violence since age 15, mostly perpetrated by non-family male acquaintances, co-workers, or strangers. Young women who are victims of sexual violence are at heightened risk of acute and chronic mental and physical health conditions. 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

• Violence, Sexual

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-27
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2024-06-05
• Last updated: 2025-08-05

Locations

7 sites across 1 country: Vietnam