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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04166851
• Other study ID #: 00008650
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Cui Yang, PhD
• Phone: 410-502-5368
• Email: cyang29[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• PrEP campaign messages developed via open contest
PrEP campaign messages will be developed via an open contest in Baltimore.
• PrEP campaign messages developed via social marketing approach
PrEP campaign messages developed with a traditional social marketing approach.

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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