Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men

NCT06443541 | Recruiting DMC

• 2 other identifiers: STUDY000064811R01MH133259
• Study Type: interventional
• Target: 3,439
• Locations: 1 country
• Sites: 7

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 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

Keywords

Behavioral Intervention; GlobalConsent; Sexual Violence

Outcome Measures

Primary Outcomes (2)

• Students' Reported Prosocial Bystander Behavior

  Students will be asked if they had engaged in any of seven prosocial bystander behaviors in the past 3 months (or since the last time completing the questionnaire). Items are scored as 0 = never performed, 1 = performed once, 2 = performed more than once. The numbers of participants who report engaging in at least one of seven prosocial bystander behaviors at least once are presented here.

  Baseline, every 6 months up to 30 months

• Students' reported Sexually Violent Behavior

  The Sexual Experiences Survey (SES) is an assessment tool used to measure the prevalence of sexual aggression. It is designed to measure the frequency and severity of sexual aggression acts committed by an individual. The SES is a self-report questionnaire developed by researchers at the University of Michigan. The Sexual Experiences Survey - Short Form Victimization is a multi-item measure to assess unwanted sexual victimization. Surveys will be provided every six months for up to 30 months.

  Baseline, every 6 months up to 30 months

Secondary Outcomes (21)

• Perceptions of Sexual Violence form at their respective university

  Baseline and up to 49 months

• Implementation Team Scale for staff and supervisors

  Baseline, month 15, month 18, and month 42

• Cultural Exchange Inventory

  Baseline, month 15, month 18, and month 42

• College Date Rape Attitudes & Behaviors Scale

  Baseline, month 15, month 18, and month 42

• Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students

  Baseline and up to 49 months

Study Arms (4)

Students

EXPERIMENTAL

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.

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

Faculty

EXPERIMENTAL

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

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

Leaders

EXPERIMENTAL

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

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

Implementation Team Members

EXPERIMENTAL

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

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

Interventions

High-intensity implementation strategies (HIS)-Students BEHAVIORAL

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.

Also known as: HIS-Students

Students

Low-intensity implementation strategies (LIS) for Students BEHAVIORAL

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.

Also known as: LIS-Students

Students

High-intensity implementation strategies (HIS) for Faculty OTHER

* 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)

Also known as: HIS-Faculty

Faculty

Low-intensity implementation strategies (LIS) for Faculty OTHER

Passive access to web-based educational materials

Also known as: LIS-Faculty

Faculty

High-intensity implementation strategies (HIS) for Leaders OTHER

* 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)

Also known as: HIS-Leaders

Leaders

Low-intensity implementation strategies (LIS) for Leaders OTHER

* 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

Also known as: LIS-Leaders

Leaders

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

* 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

Also known as: HIS-Implementation Team Members

Implementation Team Members

Low-intensity implementation strategies (LIS) Implementation Team Members OTHER

* 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

Also known as: LIS Implementation Team Members

Implementation Team Members

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• 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.
• None
• Recommendation of study staff at each participating study university
• Knowledge about the implementation landscape and implementation of GlobalConsent.
• None
• Identified by relevant study staff.
• None

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator
• Center for Creative Initiatives in Health and Population: collaborator
• Georgia State University: collaborator

Study Sites (7)

Can Tho University of Medicine and Pharmacy (CTUMP)

Can Tho, Vietnam

RECRUITING

Da Nang University of Medical Technology & Pharmacy (DUMTP)

Da Nang, Vietnam

RECRUITING

Hai Phong University of Medicine and Pharmacy

Haiphong, Vietnam

RECRUITING

Hanoi Medical University

Hanoi, 116001, Vietnam

RECRUITING

Ho Chi Minh City Medicine and Pharmacy University

Ho Chi Minh City, Vietnam

RECRUITING

Hong Bang University

Ho Chi Minh City, Vietnam

RECRUITING

Hue University of Medicine and Pharmacy

Huế, 470000, Vietnam

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Kathryn Yount, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Yount, PhD

CONTACT

404-727-8511; kathryn.yount@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Global Health

Model Details: This cluster-randomized design assigns seven universities to High-intensity implementation strategies (HIS) or Lower-intensity (LIS) implementation strategies to deliver GlobalConsent education.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 5, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be made available for sharing beginning 12 months after the publication of the primary aims papers or 12 months after the end of the performance period, whichever comes first.
• Access Criteria: Emory Dataverse for publicly available data and by reasonable request to the PI for any restricted data.

Locations

VN (7)