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

Primary Purpose

HIV/AIDS

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PrEP campaign messages developed via open contest

PrEP campaign messages developed via social marketing approach

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring Pre-exposure prophylaxis, Health Promotion, HIV/AIDS primary prevention, men who have sex with men, Neuroimaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Johns Hopkins Bloomberg School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Open contest messages

Social marketing messages

Arm Description

Participants will view the top PrEP-promotion messages developed via an open contest.

Participants will view the PrEP-promotion messages developed via social marketing.

Outcomes

Primary Outcome Measures

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)

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."

Secondary Outcome Measures

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?"

Full Information

NCT ID

NCT04166851

First Posted

October 23, 2019

Last Updated

October 10, 2023

Sponsor

Johns Hopkins Bloomberg School of Public Health

1. Study Identification

Unique Protocol Identification Number

NCT04166851

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2019 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins Bloomberg School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS

Keywords

Pre-exposure prophylaxis, Health Promotion, HIV/AIDS primary prevention, men who have sex with men, Neuroimaging

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open contest messages

Arm Type

Experimental

Arm Description

Participants will view the top PrEP-promotion messages developed via an open contest.

Arm Title

Social marketing messages

Arm Type

Active Comparator

Arm Description

Participants will view the PrEP-promotion messages developed via social marketing.

Intervention Type

Behavioral

Intervention Name(s)

PrEP campaign messages developed via open contest

Intervention Description

PrEP campaign messages will be developed via an open contest in Baltimore.

Intervention Type

Behavioral

Intervention Name(s)

PrEP campaign messages developed via social marketing approach

Intervention Description

PrEP campaign messages developed with a traditional social marketing approach.

Primary Outcome Measure Information:

Title

change of neural activity

Description

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)

Time Frame

20 seconds between participants start and finish reviewing the messages

Title

change of willingness and behavioral intention to take PrEP

Description

Time Frame

30 days between baseline and follow up

Secondary Outcome Measure Information:

Title

PrEP action and initiation

Description

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?"

Time Frame

30-day follow up

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cui Yang, PhD

Phone

410-502-5368

cyang29@jhu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cui Yang, PhD

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Bloomberg School of Public Health

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cui Yang, PhD

Phone

410-502-5368

cyang29@jhu.edu

12. IPD Sharing Statement

Learn more about this trial

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

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