A Pragmatic Trial of An Adaptive eHealth HIV Prevention Program for Diverse Adolescent MSM
NCT ID: NCT03511131
Last Updated: 2022-08-12
Study Results
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Basic Information
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COMPLETED
NA
1306 participants
INTERVENTIONAL
2018-04-18
2021-12-12
Brief Summary
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Detailed Description
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Implementation issues are particularly critical as traditional HIV prevention delivery channels have significant limitations for AMSM: few adolescents attend LGBT youth oriented programs, schools place many restrictions on discussions of MSM sexual health, and major questions remain as to the feasibility of enrolling parents of AMSM into HIV prevention programs. With 92% of adolescents (across all races and income levels) going online every day, eHealth interventions represent a critical modality for delivering AMSM- specific intervention material where youth "are." Combining online recruitment with intervention delivery across a range of devices can overcome many access barriers to engagement of AMSM in HIV prevention.
Unfortunately, there will be no single magic solution that will work for all AMSM and public health programmers should not continue to deliver the same fixed intervention when a participant is not responding. Alternatively, stepped-care strategies increase in intensity to meet the needs of those who do not respond to a less intense intervention. Using a Sequential Multiple Assignment Randomized Trial (SMART) design, the investigators will evaluate the impact of a package of increasingly intensive interventions that have already shown evidence of efficacy with diverse adolescent and young adult MSM. The SMART methodology is an ideal approach because SMART designs mimic treatment decisions as they are made in real-world clinical settings, components of traditional RCTs are embedded within the design, and participant data can be used post-hoc to inform decision rules in order to optimize implementation. Collectively the investigators brand this package of eHealth interventions as the SMART Program (Sexual Minority Adolescent Risk Taking). The SMART Program package includes: (1) 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) a more intensive online intervention designed for diverse AMSM engaging in HIV transmission risk behaviors ("Keep It Up!"); and (3) a more intensive motivational interviewing (MI) intervention that will be delivered by MI therapists via online videochat ("Young Men's Health Project"). The investigators will evaluate the impact of the SMART Program and carefully document implementation context to inform scale out with the following aims:
Aim 1: Evaluate the impact of the SMART Program and its constituent components at reducing HIV risk among AMSM. To do this, the investigators will:
1. Involve diverse AMSM (e.g., Youth Advisory Council) in developmentally adapting existing SMART Program components for AMSM ages 13-18 using the ADAPT-ITT framework.
2. Culturally and linguistically adapt the SMART Program for Spanish speaking Latino AMSM in the US.
3. Embed the SMART Program content into an eHealth platform that will allow access on a range of devices and accommodate updates. Perform alpha and beta testing.
4. Enroll a national sample of 1,938 AMSM who are diverse in terms of race/ethnicity, age, geographic region, socioeconomic status, and sexual experience history.
5. Test the effectiveness of the SMART Program at reducing HIV risk taking behaviors, increasing HIV testing, and improving prevention intentions. Consistent with a SMART design, the investigators operationalize and power the primary test of effectiveness as the first point of randomization, which tests the effectiveness of "Keep It Up!". Additional comparisons will allow the investigators to establish the response rate for "Queer Sex Ed", examine whether the more intensive "Young Men's Health Project" outperforms the less intensive "Keep It Up!" among non-responders to "Queer Sex Ed," and determine whether "Young Men's Health Project" provides added benefit to AMSM who did not respond to "Keep it Up!".
Aim 2: Test if the SMART Program has differential efficacy across important sub-groups of AMSM. Consistent with the RFA, the investigators will test intervention effects within each of the NIH designated health disparity populations (racial/ethnicity minorities, rural, low SES), and by age and language (Spanish).
Aim 3: Evaluate the delivery of the SMART Program nationally to inform scale out and determine cost-effectiveness. To reduce the science-practice gap, the investigators will utilize mixed methods to identify facilitators and barriers to the implementation of the SMART Program using a Hybrid Type 1 Effectiveness-Implementation trial design. The investigators will assess process metrics and indicators of its acceptability among AMSM and key national stakeholders, scale out feasibility, sustainability potential, and conduct a cost analysis to estimate the cost of program implementation compare to monetized benefits.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
SINGLE
Study Groups
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QSE Resp (Only follow)
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.
Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
QSE Resp (KIU at 6-month)
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.
Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
QSE Non-Resp, KIU-Control Resp
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.
Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Keep It Up-Control
HIV knowledge control condition, attention-matched to KIU (Informational)
QSE Non-Resp, KIU-Control Non-Resp, KIU
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.
Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
Keep It Up-Control
HIV knowledge control condition, attention-matched to KIU (Informational)
QSE Non-Resp, KIU Control Non-Resp, YMHP
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.
Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Keep It Up-Control
HIV knowledge control condition, attention-matched to KIU (Informational)
Young Men's Health Project
Motivational enhancement video interviewing condition (Motivational/behavioral)
QSE Non-Resp, KIU Resp
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.
Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
QSE Non-Resp, KIU Non-Resp
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.
Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
QSE Non-Resp, KIU Non-Resp, YMHP
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.
Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
Young Men's Health Project
Motivational enhancement video interviewing condition (Motivational/behavioral)
Interventions
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Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
Keep It Up-Control
HIV knowledge control condition, attention-matched to KIU (Informational)
Young Men's Health Project
Motivational enhancement video interviewing condition (Motivational/behavioral)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* reporting attraction to men;
* 13-18 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
Exclusion Criteria
* 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
13 Years
18 Years
MALE
Yes
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Northwestern University
OTHER
Responsible Party
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Brian Mustanski
Professor, Medical Social Sciences
Principal Investigators
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Brian Mustanski, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Maggie Matson, MPH
Role: STUDY_DIRECTOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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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.
Mustanski 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.
Sinno 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.
Xavier 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.
Moskowitz 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.
Mustanski 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.
Mustanski 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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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