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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: PrEP campaign messages developed via open contest; Behavioral: PrEP campaign messages developed via social marketing approach

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cui Yang, PhD; Phone Number: 410-502-5368; Email: cyang29@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins Bloomberg School of Public Health
      • Contact: Cui Yang, PhD; Phone Number: 410-502-5368; Email: cyang29@jhu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of neural activity	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)	20 seconds between participants start and finish reviewing the messages
change of willingness and behavioral intention to take PrEP	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."	30 days between baseline and follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP action and initiation	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?"	30-day follow up

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Cui Yang, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Health Promotion; Neuroimaging; Pre-exposure prophylaxis; men who have sex with men; HIV/AIDS primary prevention
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 00008650

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No