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Behavioral Intervention
QSE Non-Resp, KIU-Control Non-Resp, KIU for Adolescent Behaviors (SMART Trial)
N/A
Waitlist Available
Led By Brian Mustanski, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months: 0, 3, 6, 9, 12
Awards & highlights
SMART Trial Summary
This trial is testing a three-part HIV prevention program for male adolescents who have sex with men. The program is delivered online and uses a sequential multiple assignment randomized trial to track participants' risk level. The first part of the program is for all participants, the second part is for those at risk, and the third part is the most intensive, for those at high risk.
Eligible Conditions
- HIV (Human Immunodeficiency Virus)
- Adolescent Behaviors
- Safe Sex
SMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months: 0, 3, 6, 9, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months: 0, 3, 6, 9, 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Condom Use Intentions Scale
Condomless anal sex
HIV Testing
Secondary outcome measures
Condom Errors
HIV Knowledge
Acquired Immunodeficiency Syndrome
Other outcome measures
PrEP Knowledge/Experience
SMART Trial Design
8Treatment groups
Experimental Treatment
Group I: QSE Resp (Only follow)Experimental Treatment1 Intervention
All participants enter Queer Sex Ed (QSE) and are measured at 0, 3, 6, 9, and 12-months. This arm is comprised of participants who responded to QSE, were randomized at month-6 to no additional treatment, and then followed for the rest of the study.
Group II: QSE Resp (KIU at 6-month)Experimental Treatment2 Interventions
All participants enter Queer Sex Ed (QSE) and are measured at 0, 3, 6, 9, and 12-months. This arm is comprised of participants who responded to QSE, were randomized at month-6 to receive Keep It Up (KIU), and then followed for the rest of the study.
Group III: QSE Non-Resp, KIU-Control RespExperimental Treatment2 Interventions
All participants enter Queer Sex Ed (QSE) and are measured at 0, 3, 6, 9, and 12-months. This arm is comprised of participants who did not respond to QSE, were randomized at month-3 to receive Keep It Up-Control (KIU-Control), responded to KIU-Control at month-6, and then were followed for the rest of the study.
Group IV: QSE Non-Resp, KIU-Control Non-Resp, KIUExperimental Treatment3 Interventions
All participants enter Queer Sex Ed (QSE) and are measured at 0, 3, 6, 9, and 12-months. This arm is comprised of participants who did not respond to QSE, were randomized at month-3 to receive Keep It Up-Control (KIU-Control), did not respond to KIU-Control at month-6, and so were randomized into Keep It Up (KIU). After KIU, they were followed for the rest of the study.
Group V: QSE Non-Resp, KIU RespExperimental Treatment2 Interventions
All participants enter Queer Sex Ed (QSE) and are measured at 0, 3, 6, 9, and 12-months. This arm is comprised of participants who did not respond to QSE, were randomized at month-3 to receive Keep It Up (KIU), responded to KIU at month-6, and then were followed for the rest of the study.
Group VI: QSE Non-Resp, KIU Non-Resp, YMHPExperimental Treatment3 Interventions
All participants enter Queer Sex Ed (QSE) and are measured at 0, 3, 6, 9, and 12-months. This arm is comprised of participants who did not respond to QSE, were randomized at month-3 to receive Keep It Up (KIU), did not respond to KIU at month-6, and then were randomized into Young Men's Health Project. After YMHP, they were followed for the rest of the study.
Group VII: QSE Non-Resp, KIU Non-RespExperimental Treatment2 Interventions
All participants enter Queer Sex Ed (QSE) and are measured at 0, 3, 6, 9, and 12-months. This arm is comprised of participants who did not respond to QSE, were randomized at month-3 to receive Keep It Up (KIU), did not respond to KIU at month-6, and then were randomized into no treatment/just follow for the rest of the study.
Group VIII: QSE Non-Resp, KIU Control Non-Resp, YMHPExperimental Treatment3 Interventions
All participants enter Queer Sex Ed (QSE) and are measured at 0, 3, 6, 9, and 12-months. This arm is comprised of participants who did not respond to QSE, were randomized at month-3 to receive Keep It Up-Control (KIU-Control), did not respond to KIU-Control at month-6, and so were randomized into Young Men's Health Project (YMHP). After YMHP, they were followed for the rest of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Keep It Up
2018
N/A
~1310
Queer Sex Ed
2018
N/A
~1310
Keep It Up-Control
2018
N/A
~1310
Young Men's Health Project
2018
N/A
~1310
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
915,925 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,214,905 Total Patients Enrolled
3 Trials studying Adolescent Behaviors
2,176 Patients Enrolled for Adolescent Behaviors
David Moskowitz, PhDStudy DirectorNorthwestern University
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