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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open contest messages | Experimental | Participants will view the top PrEP-promotion messages developed via an open contest. |
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| Social marketing messages | Active Comparator | Participants will view the PrEP-promotion messages developed via social marketing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP campaign messages developed via open contest | Behavioral | PrEP campaign messages will be developed via an open contest in Baltimore. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 30 days post baseline |
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Inclusion Criteria:
Exclusion Criteria:
- Participated in open contest
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| Name | Affiliation | Role |
|---|---|---|
| Cui Yang, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Contest Messages | Participants will view the top PrEP-promotion messages developed via an open contest. PrEP campaign messages developed via open contest: PrEP campaign messages will be developed via an open contest in Baltimore. |
| FG001 | Social Marketing Messages |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2022 |
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| PrEP campaign messages developed via social marketing approach | Behavioral | PrEP campaign messages developed with a traditional social marketing approach. |
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Participants will view the PrEP-promotion messages developed via social marketing. PrEP campaign messages developed via social marketing approach: PrEP campaign messages developed with a traditional social marketing approach. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Contest Messages | Participants will view the top PrEP-promotion messages developed via an open contest. PrEP campaign messages developed via open contest: PrEP campaign messages will be developed via an open contest in Baltimore. |
| BG001 | Social Marketing Messages | Participants will view the PrEP-promotion messages developed via social marketing. PrEP campaign messages developed via social marketing approach: PrEP campaign messages developed with a traditional social marketing approach. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Interntion to use PrEP | Suppose that PrEP is at least 90% effective in preventing HIV when taken as prescribed. How likely would you plan to take PrEP if it were available for free?
Mean of participant choice is reported | Some participants didn't answer due to skip pattern in survey | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed the follow-up survey are reported. | Posted | Mean | Standard Deviation | units on a scale | baseline, 30 days post baseline |
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Adverse Events Were Not Collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Contest Messages | Participants will view the top PrEP-promotion messages developed via an open contest. PrEP campaign messages developed via open contest: PrEP campaign messages will be developed via an open contest in Baltimore. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Social Marketing Messages | Participants will view the PrEP-promotion messages developed via social marketing. PrEP campaign messages developed via social marketing approach: PrEP campaign messages developed with a traditional social marketing approach. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cui Yang | Rutgers School of Public Health | 1-732-235-9754 | cui.yang@rutgers.edu |
| Sep 26, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2022 | Sep 25, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| Between 18 and 65 years |
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| >=65 years |
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