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

Overview

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.

Interventions

• Behavioral High-intensity implementation strategies (HIS)-Students
  Students in the HIS group will receive educational outreach in a pre-implementation 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
• 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 * Biwee
• 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

Primary outcome measures

• Students' Reported Prosocial Bystander Behavior [Time frame: Baseline (month 10), every 6 months up to 30 months]
• Students' reported Sexually Violent Behavior [Time frame: Baseline (month 10), every 6 months up to 30 months]

Secondary outcome measures (12)

• Perceptions of Sexual Violence form at their respective university [Time frame: Baseline (month 10) and up to 49 months]
• Implementation Team Scale for staff and supervisors [Time frame: Baseline, month 25, month 29, and month 32]
• Cultural Exchange Inventory [Time frame: Baseline, month 25, month 29, and month 32]
• College Date Rape Attitudes & Behaviors Scale [Time frame: Baseline, month 25, month 29, and month 32]
• Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students [Time frame: Baseline and up to 49 months]
• Acceptability, Feasibility, and Appropriateness of GlobalConsent [Time frame: Baseline and up to 49 months]
• Sexual Violence Legality and Harm (Information about Sexual Activity) [Time frame: Baseline and up to 49 months]
• Active Consent (Information about Sexual Consent) [Time frame: Baseline and up to 49 months]
• Rejection of Rape Myths (Attitudes about Sexual Situations) [Time frame: Baseline and up to 49 months]
• Perceptions of Campus Attitudes [Time frame: Baseline and up to 49 months]
• Alcohol Impairment Knowledge/Effects of Alcohol on Cognition [Time frame: Baseline, every 6 months for up to 30 months.]
• Empathy for Rape Victims [Time frame: Baseline (month 10), every 6 months for up to 30 months.]

Eligibility 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, 4, 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Vietnam · 7 centers

• Can Tho University of Medicine and Pharmacy (CTUMP) — Can Tho
• Da Nang University of Medical Technology & Pharmacy (DUMTP) — Da Nang
• Hai Phong University of Medicine and Pharmacy — Haiphong
• Hanoi Medical University — Hanoi
• Ho Chi Minh City Medicine and Pharmacy University — Ho Chi Minh City
• Hong Bang University — Ho Chi Minh City
• Hue University of Medicine and Pharmacy — Huế

Publications

• 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. PMID 39315253
• 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. PMID 39210388

Identifiers

NCT: NCT06443541 · STUDY00006481 · 1R01MH133259 · 2025P011593

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗