A Pragmatic Trial of An Adaptive eHealth HIV Prevention Program for Diverse Adolescent MSM
SMART
1 other identifier
interventional
1,306
1 country
1
Brief Summary
This pragmatic trial of an HIV prevention program focuses on HIV risk-reduction in men who have sex with men (MSM) ages 13-18. The design is a three-tiered, internet-based HIV prevention intervention series that uses a sequential multiple assignment randomized trial (SMART) to track adolescent MSM reporting varying degree of sexual risk.The program package includes: (1-low risk) a universally-delivered, brief, online sexual health education program designed for sexual and gender minority youth regardless of whether they are sexually active (Queer Sex Ed); (2-middle risk) a more intensive online intervention designed for diverse AMSM engaging in HIV transmission risk behaviors (Keep It Up!), and (3-high risk) the most intensive is a motivational interviewing (MI) intervention that will be delivered by MI therapists via online videochat (Young Men's Health Project).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Apr 2018
Typical duration for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2018
CompletedStudy Start
First participant enrolled
April 18, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2021
CompletedAugust 12, 2022
August 1, 2022
3.7 years
March 29, 2018
August 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Condomless anal sex
Changes in condomless anal sex acts from baseline to 12-months.
12-months
Condom Use Intentions Scale
This is a multi-item scale which asks participants about their plans and abilities to use condoms in the future. It has two subscales. The first subscale (Condom Use) asks about participants' likelihood to use condoms with partners. An example item for Condom Use is: "How likely is it that you will use a condom every time you have sex?" The 11-items for this subscale are measured from very unlikely (1) to very likely (4) \[averaged min value 1, averaged max value 4\]. High values mean a better outcome, or likely condom use with partners. The second subscale (Self-Efficacy) asks participants' ability to use condoms. An example item for Self-Efficacy is: "How confident are you that you would be able to be sure you had condoms with you?" The 5-items for this subscale are measured from not at all confident (1) to extremely confident (7) \[averaged min value 1, averaged max value 7\]. High values mean a better outcome, or more confidence at using condoms. The two subscales are not combined.
12-months
HIV Testing
Participants are asked to self-reported their history of actual getting HIV tested.
12-months
Secondary Outcomes (3)
HIV Knowledge
Months: 0, 3, 6, 9, 12
HIV/AIDS Motivation and Behavioral Skills
Months: 0, 3, 6, 9, 12
Condom Errors
Months: 0, 3, 6, 9, 12
Other Outcomes (1)
PrEP Knowledge/Experience
Months: 0, 3, 6, 9, 12
Study Arms (8)
QSE Resp (Only follow)
OTHERAll 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.
QSE Resp (KIU at 6-month)
OTHERAll 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.
QSE Non-Resp, KIU-Control Resp
OTHERAll 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.
QSE Non-Resp, KIU-Control Non-Resp, KIU
OTHERAll 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.
QSE Non-Resp, KIU Control Non-Resp, YMHP
OTHERAll 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.
QSE Non-Resp, KIU Resp
OTHERAll 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.
QSE Non-Resp, KIU Non-Resp
OTHERAll 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.
QSE Non-Resp, KIU Non-Resp, YMHP
OTHERAll 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.
Interventions
Comprehensive sexual health education program condition (Informational)
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
HIV knowledge control condition, attention-matched to KIU (Informational)
Motivational enhancement video interviewing condition (Motivational/behavioral)
Eligibility Criteria
You may qualify if:
- identifying as male-assigned at birth
- reporting attraction to men;
- years old
- self-reported HIV-negative at the beginning of the study (or have never been HIV tested/do not know their HIV status)
- able to read English or Spanish,
- has a usable e-mail address, textable phone number, and access to the internet or smart-phone/-device
You may not qualify if:
- identifying as female-assigned at birth
- reporting no attraction men
- identifying as under 13 years of age
- identifying as 19 years old or older
- self-reported HIV-positive
- unable to read English or Spanish
- unable to have access to or use email, text messaging, voice calling
- unable to have access to the internet or a smart-phone/-device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (7)
Yellin H, Wang Y, Huebner DM, Rodriguez-Diaz CE, Macapagal K, Newcomb ME, Mustanski B, Ruiz MS. An empirical test of the Information-Motivation-Behavioral Skills model of willingness and intention to use HIV pre-exposure prophylaxis among adolescent men who have sex with men. Ann Behav Med. 2025 Jan 4;59(1):kaaf070. doi: 10.1093/abm/kaaf070.
PMID: 40971723DERIVEDMustanski B, Macapagal K, Li DH, Rodriguez-Diaz CE, Saber R, Matson M, Moskowitz DA, Rendina HJ, Laber E, Ryan DT, Newcomb ME. Effectiveness of the smart program: Stepped-care HIV prevention for gay and bisexual adolescent boys. Health Psychol. 2025 Mar;44(3):321-331. doi: 10.1037/hea0001471.
PMID: 39992778DERIVEDSinno J, Macapagal K, Mustanski B. Social Media and Online Dating Safety Practices by Adolescent Sexual and Gender Diverse Men: Mixed-Methods Findings From the SMART Study. J Adolesc Health. 2024 Jan;74(1):113-122. doi: 10.1016/j.jadohealth.2023.07.030. Epub 2023 Oct 4.
PMID: 37791926DERIVEDXavier Hall CD, Wood CV, Hurtado M, Moskowitz DA, Dyar C, Mustanski B. Identifying leaks in the STEM recruitment pipeline among sexual and gender minority US secondary students. PLoS One. 2022 Jun 3;17(6):e0268769. doi: 10.1371/journal.pone.0268769. eCollection 2022.
PMID: 35658021DERIVEDMoskowitz DA, Moran KO, Matson M, Alvarado-Avila A, Mustanski B. The PrEP Cascade in a National Cohort of Adolescent Men Who Have Sex With Men. J Acquir Immune Defic Syndr. 2021 Apr 15;86(5):536-543. doi: 10.1097/QAI.0000000000002613.
PMID: 33399311DERIVEDMustanski B, Moskowitz DA, Moran KO, Newcomb ME, Macapagal K, Rodriguez-Diaz C, Rendina HJ, Laber EB, Li DH, Matson M, Talan AJ, Cabral C. Evaluation of a Stepped-Care eHealth HIV Prevention Program for Diverse Adolescent Men Who Have Sex With Men: Protocol for a Hybrid Type 1 Effectiveness Implementation Trial of SMART. JMIR Res Protoc. 2020 Aug 11;9(8):e19701. doi: 10.2196/19701.
PMID: 32779573DERIVEDMustanski B, Moskowitz DA, Moran KO, Rendina HJ, Newcomb ME, Macapagal K. Factors Associated With HIV Testing in Teenage Men Who Have Sex With Men. Pediatrics. 2020 Mar;145(3):e20192322. doi: 10.1542/peds.2019-2322. Epub 2020 Feb 11.
PMID: 32047100DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Mustanski, PhD
Northwestern University
- STUDY DIRECTOR
Maggie Matson, MPH
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Medical Social Sciences
Study Record Dates
First Submitted
March 29, 2018
First Posted
April 27, 2018
Study Start
April 18, 2018
Primary Completion
December 12, 2021
Study Completion
December 12, 2021
Last Updated
August 12, 2022
Record last verified: 2022-08