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

Emory University

Status: Enrolling

Conditions: Violence, Sexual

Treatments: Other: High-intensity implementation strategies (HIS) for Faculty; Other: High-intensity implementation strategies (HIS) for Implementation Team Members; Other: Low-intensity implementation strategies (LIS) for Faculty; Other: Low-intensity implementation strategies (LIS) Implementation Team Members; Other: Low-intensity implementation strategies (LIS) for Leaders; Behavioral: Low-intensity implementation strategies (LIS) for Students; Other: High-intensity implementation strategies (HIS) for Leaders; Behavioral: High-intensity implementation strategies (HIS)-Students

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06443541

1R01MH133259 (U.S. NIH Grant/Contract)

STUDY00006481

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,439 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Students:

• 18 and older
• 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.

Exclusion Criteria for Students:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)

Inclusion Criteria for Faculty:

• 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.

Exclusion Criteria for Faculty:

• None

Inclusion Criteria for Leaders:

• Recommendation of study staff at each participating study university
• Knowledge about the implementation landscape and implementation of GlobalConsent.

Exclusion Criteria for Leaders:

• None

Inclusion Criteria for Implementation Teams:

• Identified by relevant study staff.

Exclusion Criteria for Implementation Teams:

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,439 participants in 4 patient groups

Students

Experimental group

Description:

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.

Treatment:

Behavioral: High-intensity implementation strategies (HIS)-Students

Behavioral: Low-intensity implementation strategies (LIS) for Students

Faculty

Experimental group

Description:

Faculty will receive access to educational material based on the university randomization implementation strategies group.

Treatment:

Other: Low-intensity implementation strategies (LIS) for Faculty

Other: High-intensity implementation strategies (HIS) for Faculty

Leaders

Experimental group

Description:

Leaders will receive site-specific (University) invitations and material based on the implementation strategies group.

Treatment:

Other: High-intensity implementation strategies (HIS) for Leaders

Other: Low-intensity implementation strategies (LIS) for Leaders

Implementation Team Members

Experimental group

Description:

Implementation team members will receive passive access to web-based materials and training according to the university-specific implementation strategies group.

Treatment:

Other: Low-intensity implementation strategies (LIS) Implementation Team Members

Other: High-intensity implementation strategies (HIS) for Implementation Team Members