HIV/AIDSNCT04166851
Using Open Contest and Neuro-influence Experiment to Develop and Evaluate PrEP Promotion Messages for High Risk Men
A study testing PrEP campaign messages developed via open contest and PrEP campaign messages developed via social marketing approach in people with HIV/AIDS, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- PrEP campaign messages developed via open contest and PrEP campaign messages developed via social marketing approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Participated in open contest
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
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.
- Conditions
- HIV/AIDS
- Being tested
- PrEP campaign messages developed via open contest, PrEP campaign messages developed via social marketing approach
- Keywords
- Pre-exposure prophylaxis, Health Promotion, HIV/AIDS primary prevention, men who have sex with men, Neuroimaging
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP campaign messages developed via open contestBehavioural
PrEP campaign messages will be developed via an open contest in Baltimore.
PrEP campaign messages developed via social marketing approachBehavioural
PrEP campaign messages developed with a traditional social marketing approach.
| Study group | Role | What they receive |
|---|---|---|
| Open contest messages | Experimental | Participants will view the top PrEP-promotion messages developed via an open contest. Receives: Behavioral: PrEP campaign messages developed via open contest |
| Social marketing messages | Active comparator | Participants will view the PrEP-promotion messages developed via social marketing. Receives: Behavioral: PrEP campaign messages developed via social marketing approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 30 days post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start15 Nov 2019
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cui Yang, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166851
- Sponsor's protocol ID
- 00008650
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2019
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Open Contest and Neuro-influence Experiment to Develop and Evaluate PrEP Promotion Messages for High Risk Men
- ClinicalTrials.gov ID
- NCT04166851
- Acronym / sponsor ID
- 00008650
- Conditions
- HIV/AIDS
- Keywords
- Pre-exposure prophylaxis, Health Promotion, HIV/AIDS primary prevention, men who have sex with men, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Posted 22 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open contest messages | Experimental | Behavioral: PrEP campaign messages developed via open contestParticipants will view the top PrEP-promotion messages developed via an open contest. |
| Social marketing messages | Active comparator | Behavioral: PrEP campaign messages developed via social marketing approachParticipants will view the PrEP-promotion messages developed via social marketing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years and older
- Biological male sex at birth
- Sexually active with men in the past 6 months
- Never taken PrEP
- HIV negative
Key exclusion criteria (1 listed)
- Participated in open contest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP campaign messages developed via open contestPrEP campaign messages will be developed via an open contest in Baltimore. | Behavioural | Open contest messages |
| PrEP campaign messages developed via social marketing approachPrEP campaign messages developed with a traditional social marketing approach. | Behavioural | Social marketing messages |
Primary outcome
Change of Willingness to Take PrEP
Time frame: baseline, 30 days post baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HIV/AIDS
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cui Yang, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP campaign messages developed via open contest and PrEP campaign messages developed via social marketing approach in people with HIV/AIDS, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Willingness to Take PrEP (time frame: baseline, 30 days post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.