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A Pragmatic Trial of An Adaptive eHealth HIV Prevention Program for Diverse Adolescent MSM (SMART)

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ClinicalTrials.gov Identifier: NCT03511131
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Brian Mustanski, Northwestern University

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).

Condition or disease Intervention/treatment Phase
Hiv Adolescent Behavior Sex, Safe Behavioral: Queer Sex Ed Behavioral: Keep It Up Behavioral: Keep It Up-Control Behavioral: Young Men's Health Project Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1878 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Pragmatic Trial of An Adaptive eHealth HIV Prevention Program for Diverse Adolescent MSM
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Behavioral: Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Other Name: QSE, SMART Sex Ed

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.
Behavioral: Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Other Name: QSE, SMART Sex Ed

Behavioral: Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
Other Name: KIU, SMART Squad

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.
Behavioral: Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Other Name: QSE, SMART Sex Ed

Behavioral: Keep It Up-Control
HIV knowledge control condition, attention-matched to KIU (Informational)
Other Name: KIU-Control, SMART Sex Ed 2.0

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.
Behavioral: Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Other Name: QSE, SMART Sex Ed

Behavioral: Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
Other Name: KIU, SMART Squad

Behavioral: Keep It Up-Control
HIV knowledge control condition, attention-matched to KIU (Informational)
Other Name: KIU-Control, SMART Sex Ed 2.0

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.
Behavioral: Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Other Name: QSE, SMART Sex Ed

Behavioral: Keep It Up-Control
HIV knowledge control condition, attention-matched to KIU (Informational)
Other Name: KIU-Control, SMART Sex Ed 2.0

Behavioral: Young Men's Health Project
Motivational enhancement video interviewing condition (Motivational/behavioral)
Other Name: YMHP, SMART Sessions

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.
Behavioral: Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Other Name: QSE, SMART Sex Ed

Behavioral: Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
Other Name: KIU, SMART Squad

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.
Behavioral: Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Other Name: QSE, SMART Sex Ed

Behavioral: Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
Other Name: KIU, SMART Squad

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.
Behavioral: Queer Sex Ed
Comprehensive sexual health education program condition (Informational)
Other Name: QSE, SMART Sex Ed

Behavioral: Keep It Up
Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
Other Name: KIU, SMART Squad

Behavioral: Young Men's Health Project
Motivational enhancement video interviewing condition (Motivational/behavioral)
Other Name: YMHP, SMART Sessions




Primary Outcome Measures :
  1. Condomless anal sex [ Time Frame: 12-months ]
    Changes in condomless anal sex acts from baseline to 12-months.

  2. Condom Use Intentions Scale [ Time Frame: 12-months ]
    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.

  3. HIV Testing [ Time Frame: 12-months ]
    Participants are asked to self-reported their history of actual getting HIV tested.


Secondary Outcome Measures :
  1. HIV Knowledge [ Time Frame: Months: 0, 3, 6, 9, 12 ]
    The brief HIV/AIDS Knowledge questionnaire assesses knowledge of transmission and prevention of HIV. Example items that are dichotomously measured as true/false, include: "A person can get HIV by sharing a glass of water with someone who has HIV," "There is a vaccine that can stop people (or adults) from getting HIV," "Using a latex condom or rubber can lower a person's chance of getting HIV," etc.

  2. HIV/AIDS Motivation and Behavioral Skills [ Time Frame: Months: 0, 3, 6, 9, 12 ]
    Motivation (e.g. perceived threat of HIV/STI infection, motivation to become safer), social norms (e.g., partners/friends/family members opinions about condom use), and behavioral skills (e.g., negotiating condom use) will be assessed. An example of motivation-based measures would be: "True or False: You really only need to use condoms during one night stands." An example of social norm-based measures would be: "How likely/unlikely is it that you will have sex without a condom because you are afraid of what a partner might do to you if you ask to use condoms?" An example of skills-based measures would be: "How hard would it be for you to discuss safer sex with a partner in a non-sexual setting, such as while riding in your car?" More specific behavioral skills are also measured within the The Health Protective Communication Scale. An example of this would be, "In the past 12 months, have you asked a new sex partner about the number of past sex partners (he/she) had?"

  3. Condom Errors [ Time Frame: Months: 0, 3, 6, 9, 12 ]
    An adaptation of the Condom Errors Questionnaire will be asked, which has been found to be predictive of condom breakage and slippage, and STI contraction. An example item from this questionnaire is: "When you used condoms during the LAST 6 MONTHS, how often was the condom package checked for visible damage before having sex?"


Other Outcome Measures:
  1. PrEP Knowledge/Experience [ Time Frame: Months: 0, 3, 6, 9, 12 ]
    The Knowledge of and Experience with Pre-Exposure Prophylaxis (PrEP) scale (for adolescents) will be used. This is a validated scale that asks questions such as: (Agree/Disagree) "Taking pre-exposure prophylaxis (a pill, also known as PrEP or Truvada) regularly can reduce the risk of contracting HIV from an HIV-positive sex partner."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male-assigned at birth
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • identifying as male-assigned at birth
  • 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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511131


Contacts
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Contact: Brian Mustanski, PhD 312-503-5421 brian@northwestern.edu
Contact: David Moskowitz, PhD 312-503-0055 david.moskowitz@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: David Moskowitz, PhD    312-503-0055    david.moskowitz@northwestern.edu   
Sponsors and Collaborators
Northwestern University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Brian Mustanski, PhD Northwestern University
Study Director: David Moskowitz, PhD Northwestern University
  Study Documents (Full-Text)

Documents provided by Brian Mustanski, Northwestern University:
Informed Consent Form  [PDF] November 2, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Mustanski, Professor, Medical Social Sciences, Northwestern University
ClinicalTrials.gov Identifier: NCT03511131    
Other Study ID Numbers: 5U01MD011281 ( U.S. NIH Grant/Contract )
5U01MD011281 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Mustanski, Northwestern University:
HIV prevention
Adolescent risk-taking behaviors