Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (NCT06443541) | Clinical Trial Compass
RecruitingNot Applicable
Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
Vietnam3,439 participantsStarted 2024-03-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Students' Reported Prosocial Bystander Behavior
Timeframe: Baseline (month 10), every 6 months up to 30 months
2
Students' reported Sexually Violent Behavior
Timeframe: Baseline (month 10), every 6 months up to 30 months