ClinicalTrials.gg
CompletedNCT04166851Updated Oct 22, 2024Results posted

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

An interventional study of PrEP campaign messages developed via open contest and PrEP campaign messages developed via social marketing approach in HIV/AIDS, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV/AIDS

Keywords

  • Pre-exposure prophylaxis
  • Health Promotion
  • HIV/AIDS primary prevention
  • men who have sex with men
  • Neuroimaging
03

In context

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's enrollment of 23 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 369 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

- Participated in open contest

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralPrEP campaign messages developed via open contest

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

  • BehavioralPrEP campaign messages developed via social marketing approach

    PrEP campaign messages developed with a traditional social marketing approach.

06

What researchers measure

Primary outcomes

  1. Change of Willingness to Take PrEP

    Questions on willingness 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 "Extremely unlikely-1," "Somewhat unlikely-2," "Somewhat likely-3," "Extremely likely-4." The mean of the changes between baseline and after participants reviewed the messages was calculated.

    Time frame: baseline, 30 days post baseline

07

Results

Posted Oct 22, 2024

Participant flow

Participant flow — Overall Study
MilestoneOpen Contest MessagesSocial Marketing Messages
Started149
Completed149
Not completed00

Outcome measures

PrimaryChange of Willingness to Take PrEP

Questions on willingness 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 "Extremely unlikely-1," "Somewhat unlikely-2," "Somewhat likely-3," "Extremely likely-4." The mean of the changes between baseline and after participants reviewed the messages was calculated.

Time frame:
baseline, 30 days post baseline
Reported as:
Mean · units on a scale
Change of Willingness to Take PrEP
units on a scaleOpen Contest MessagesSocial Marketing Messages
Change of Willingness to Take PrEP0 ± 00.5 ± 0.71

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Open Contest Messages———
Social Marketing Messages———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Open Contest MessagesSocial Marketing MessagesTotal
<=18 years000
Between 18 and 65 years13922
>=65 years101
Age, Continuous
Age, Continuous(years)Open Contest MessagesSocial Marketing MessagesTotal
Mean34 (23 to 65)32 (24 to 56)33 (23 to 65)
Sex: Female, Male
Sex: Female, Male(Participants)Open Contest MessagesSocial Marketing MessagesTotal
Female000
Male14923
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Open Contest MessagesSocial Marketing MessagesTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American13821
White112
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Open Contest MessagesSocial Marketing MessagesTotal
United States14923
Interntion to use PrEP
Interntion to use PrEP(units on a scale)Open Contest MessagesSocial Marketing MessagesTotal
Mean3 ± 1.203.6 ± 0.553.18 ± 1.07
08

Study locations

1 site
  • Johns Hopkins Bloomberg School of Public Health
    Baltimore, Maryland 21205, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 26, 2022
  • Informed consent form · Nov 28, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04166851
Responsible party
Sponsor
First posted
Nov 18, 2019
Start date
Nov 15, 2019
Primary completion
Oct 1, 2023
Completion
Oct 30, 2023
Results posted
Oct 22, 2024
Last update
Oct 22, 2024

Study contacts

Cui Yang, PhD
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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