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Using Open Contest and Neuro-influence Experiment to Develop and Evaluate PrEP Promotion Messages for High Risk Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04166851
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
The aim of this study is to examine the utility of neuroimaging technique to evaluate pre-exposure prophylaxis (PrEP) promotion messages for men who have sex with men (MSM) at risk of HIV in Baltimore.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: PrEP campaign messages developed via open contest Behavioral: PrEP campaign messages developed via social marketing approach Not Applicable

Detailed Description:
This study will examine the utility of neuroimaging technique to evaluate PrEP promotion messages for MSM at risk of HIV in Baltimore. The investigators hypothesize that participants viewing top messages developed via open contests will show higher brain activation in the Medial Prefrontal Cortex (MPFC) regions than those viewing messages developed by a social marketing approach. The investigators further hypothesize brain activation in the MPFC regions is significantly more correlated with PrEP behavioral intention, initiation, and action than self-reported message effectiveness.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Using Open Contest and Neuro-influence Experiment to Develop and Evaluate PrEP Promotion Messages for High Risk Men
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Open contest messages
Participants will view the top PrEP-promotion messages developed via an open contest.
Behavioral: PrEP campaign messages developed via open contest
PrEP campaign messages will be developed via an open contest in Baltimore.

Active Comparator: Social marketing messages
Participants will view the PrEP-promotion messages developed via social marketing.
Behavioral: PrEP campaign messages developed via social marketing approach
PrEP campaign messages developed with a traditional social marketing approach.




Primary Outcome Measures :
  1. change of neural activity [ Time Frame: 20 seconds between participants start and finish reviewing the messages ]
    change of the ratio of oxygenated (O2HB) to deoxygenated (HHB) hemoglobin in the Medial Prefrontal Cortex (MPFC) regions measured by functional near infrared spectroscopy (fNIRS)

  2. change of willingness and behavioral intention to take PrEP [ Time Frame: 60 days between baseline and follow up ]
    questions on willingness and behavioral intention to take PrEP. Participants will be asked, "Suppose that PrEP is at least 90% effective in preventing HIV when taken daily. How likely would you be to take PrEP if it were available for free?" with responses ranging from "I would definitely take it" to "I would definitely not take it." Participants will be asked, "PrEP is currently available with a prescription from your doctor and research has shown that a majority of insurance companies cover most or all of the costs of PrEP. Do you plan to begin PrEP?" Response options range from "Yes, I will definitely begin taking PrEP" to "No, I definitely will not begin taking PrEP."


Secondary Outcome Measures :
  1. PrEP action and initiation [ Time Frame: 60-day follow up ]
    questions on "Have you spoken with a provider about PrEP during the past 30 days?" and "Have you started taking PrEP during the past 30 days?"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • 18 years and older
  • Biological male sex at birth
  • Sexually active with men in the past 6 months
  • Never taken PrEP
  • HIV negative
  • Reside in Baltimore City or surrounding counties
  • Meet one of the criteria for being an appropriate PrEP candidate (i.e. in a relationship with a partner not known to be HIV-negative; are in a nonmonogamous relationship; have had any condomless anal sex with a casual male partner regardless of status in the prior 6 months; or had a positive sexual transmitted infection (STI) diagnosis within the prior 6 months).

Exclusion Criteria:

- Participated in open contest


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): NCT04166851


Contacts
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Contact: Cui Yang, PhD 410-502-5368 cyang29@jhu.edu

Locations
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United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Contact: Cui Yang, PhD    410-502-5368    cyang29@jhu.edu   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Cui Yang, PhD Johns Hopkins Bloomberg School of Public Health

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04166851    
Other Study ID Numbers: 00008650
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019

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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 Johns Hopkins Bloomberg School of Public Health:
Pre-exposure prophylaxis
Health Promotion
HIV/AIDS primary prevention
men who have sex with men
Neuroimaging