HIV/AIDS
Conditions
Keywords
Pre-exposure prophylaxis, Health Promotion, HIV/AIDS primary prevention, men who have sex with men, Neuroimaging
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.
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.
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Willingness to Take PrEP | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 9 |
| Total | 23 |
Baseline characteristics
| Characteristic | Open Contest Messages | Social Marketing Messages | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 9 Participants | 22 Participants |
| Age, Continuous | 34 years | 32 years | 33 years |
| Interntion to use PrEP | 3 units on a scale STANDARD_DEVIATION 1.2 | 3.6 units on a scale STANDARD_DEVIATION 0.55 | 3.18 units on a scale STANDARD_DEVIATION 1.07 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 8 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 14 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: baseline, 30 days post baseline
Population: Participants who completed the follow-up survey are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Contest Messages | Change of Willingness to Take PrEP | 0 units on a scale | Standard Deviation 0 |
| Social Marketing Messages | Change of Willingness to Take PrEP | 0.5 units on a scale | Standard Deviation 0.71 |