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NCT03511131: SMART
A Pragmatic Trial of An Adaptive eHealth HIV Prevention Program for Diverse Adolescent MSM
NA trial testing Queer Sex Ed in Hiv in 1,306 participants. Completed in 12 December 2021.
12 December 2021
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 1,306 |
| Start date | 18 April 2018 |
| Primary completion | 12 December 2021 |
| Estimated completion | 12 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Queer Sex Ed
- Keep It Up
- Keep It Up-Control
- Young Men's Health Project
Conditions studied
- Hiv — all drugs for Hiv →
- Adolescent Behavior — all drugs for Adolescent Behavior →
- Sex, Safe — all drugs for Sex, Safe →
Sponsor
Northwestern University
Who can join
Adults 13 to 18, male only, with Hiv or Adolescent Behavior. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Factors Associated With HIV Testing in Teenage Men Who Have Sex With Men.
Mustanski B, Moskowitz DA, Moran KO, Rendina HJ, et al · · 2020 · cited 38× · PMID 32047100 · DOI 10.1542/peds.2019-2322 -
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.
Mustanski B, Moskowitz DA, Moran KO, Newcomb ME, et al · · 2020 · cited 32× · PMID 32779573 · DOI 10.2196/19701 -
Effectiveness of the SMART Sex Ed program among 13-18 year old English and Spanish speaking adolescent men who have sex with men.
Mustanski B, Saber R, Macapagal K, Matson M, et al · · 2023 · cited 18× · PMID 35951143 · DOI 10.1007/s10461-022-03806-2 -
Social Media and Online Dating Safety Practices by Adolescent Sexual and Gender Diverse Men: Mixed-Methods Findings From the SMART Study.
Sinno J, Macapagal K, Mustanski B. · · 2024 · cited 5× · PMID 37791926 · DOI 10.1016/j.jadohealth.2023.07.030 -
Effectiveness of the smart program: Stepped-care HIV prevention for gay and bisexual adolescent boys.
Mustanski B, Macapagal K, Li DH, Rodriguez-Diaz CE, et al · · 2025 · cited 1× · PMID 39992778 · DOI 10.1037/hea0001471 -
Use of a custom testing center locator tool to improve STI and HIV testing rates in adolescent men who have sex with men as part of an online sexual health program.
Saber R, Mongrella M, Matson M, Carty-Fickes E, et al · · 2022 · cited 1× · PMID 37228693 · DOI 10.1016/j.procs.2022.09.088 -
Identifying leaks in the STEM recruitment pipeline among sexual and gender minority US secondary students.
Xavier Hall CD, Wood CV, Hurtado M, Moskowitz DA, et al · · 2022 · cited 1× · PMID 35658021 · DOI 10.1371/journal.pone.0268769 -
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.
Yellin H, Wang Y, Huebner DM, Rodríguez-Díaz CE, et al · · 2025 · PMID 40971723 · DOI 10.1093/abm/kaaf070
Verify or expand the search:
- PubMed search for NCT03511131
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03511131 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwestern University
- Last refreshed: 12 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03511131.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing