Clinical trial NCT06443541: Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
Official title: SCALE: Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Violence, Sexual
Keywords: Behavioral Intervention
GlobalConsent
Sexual Violence
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Center for Creative Initiatives in Health and Population
name: Georgia State University
First posted: 2024-06-05
Enrollment: 3439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This cluster-randomized design assigns six universities to High-intensity implementation strategies (HIS) or Lower-intensity (LIS) implementation strategies to deliver GlobalConsent education.
Primary purpose: PREVENTION

Brief 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 six 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 best strategies for launching GlobalConsent at scale, to address a gendered risk factor in adolescence, and thereby, improve an array 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 genders 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 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.

Eligibility criteria: Inclusion Criteria for Students:

* 18-24 years old,
* Men who self-identify as heterosexual or bisexual (who are attracted to women),
* Enrolled as first-year students in any of the six 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 six participating study universities will be eligible to participate in the climate 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 environment 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

Primary outcomes:
measure: Students' Reported Prosocial Bystander Behavior
timeFrame: Baseline, quarterly up to 28 months
measure: Students' reported Sexually Violent Behavior
timeFrame: Baseline, quarterly up to 28 months
Secondary outcomes:
measure: Perceptions of Sexual Violence form at their respective university
timeFrame: Baseline and up to 49 months
measure: Implementation Team Scale for staff and supervisors
timeFrame: Baseline, month 15, month 18, and month 42
measure: Cultural Exchange Inventory
timeFrame: Baseline, month 15, month 18, and month 42
measure: College Date Rape Attitudes & Behaviors Scale
timeFrame: Baseline, month 15, month 18, and month 42
measure: Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students
timeFrame: Baseline and up to 49 months
measure: Acceptability, Feasibility, and Appropriateness of GlobalConsent
timeFrame: Baseline and up to 49 months
measure: Sexual Violence Legality and Harm (Information about Sexual Activity)
timeFrame: Baseline and up to 49 months
measure: Active Consent (Information about Sexual Consent)
timeFrame: Baseline and up to 49 months
measure: Rejection of Rape Myths (Attitudes about Sexual Situations)
timeFrame: Baseline and up to 49 months
measure: Perceptions of Campus Climate
timeFrame: Baseline and up to 49 months
measure: Alcohol Impairment Knowledge/Effects of Alcohol on Cognition
timeFrame: Baseline, quarterly up to 28 months
measure: Empathy for Rape Victims
timeFrame: Baseline, quarterly up to 28 months
measure: Sexual Communication Attitudes
timeFrame: Baseline, quarterly up to 28 months
measure: Bystander Self-Efficacy
timeFrame: Baseline, quarterly up to 28 months
measure: Bystander Intention to Intervene (Readiness to Intervene)
timeFrame: Baseline, quarterly up to 28 months
measure: Severity Measure for Depression
timeFrame: Baseline
measure: Generalized Anxiety Disorder
timeFrame: Baseline
measure: Disability Assessment and Schedule
timeFrame: Baseline
measure: Diagnostic and Statistical Manual (DSM)-5 Cross Cutting Symptom Measure
timeFrame: Baseline
Other outcomes:
Locations:
city: Cần Thơ
country: Vietnam
facility: Can Tho University of Medicine and Pharmacy (CTUMP)
city: Da Nang
country: Vietnam
facility: Da Nang University of Medical Technology & Pharmacy (DUMTP)
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
city: Ho Chi Minh City
country: Vietnam
facility: Ho Chi Minh City Medicine and Pharmacy University
city: Huế
country: Vietnam
facility: Hue University of Medicine and Pharmacy
city: Hải Phòng
country: Vietnam
facility: Hai Phong University of Medicine and Pharmacy
Study officials:
affiliation: Emory University
name: Kathryn Yount, PhD
role: PRINCIPAL_INVESTIGATOR
References: