HIV Infections, Alcohol Abuse
Conditions
Brief summary
The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.
Interventions
BEHAVIORALBrief Electronic Intervention
The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so.
BEHAVIORALAttention-Matched Control
Participants will view a video clip on general health promotion that is a similar length as the intervention arm.
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Intervention model description
Randomized controlled trial where participants are assigned to either a treatment or control group.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Biologically male 2. Aged 18 or older 3. Fluent English speaker 4. Unprotected anal sex with a casual male partner at least once in the past 3 months 5. Heavy alcohol use during the past 2-weeks (\>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion) 6. Breath alcohol concentration (BrAC) of .000 at the time of enrollment 7. No history of complex alcohol withdrawal 8. HIV-negative
Exclusion criteria
1. Individuals who are HIV-positive 2. Individuals who participated in other phases of the research 3. Individuals who report being coerced to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of New Sex Partners, Past 30 Days | Past 30 days | Assessed via self-report using Timeline Follow Back (TLFB) |
| Number of Condomless Anal Sex Events, Past 30 Days | Past 30 days | Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events. |
| Number of Drinking Days, Past 30 Days | Past 30 days | Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30 |
| Number of Heavy Drinking Days (5 or More), Past 30 Days | Past 30 days | Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days. |
| Average Number of Drinks Per Drinking Day | Past 30 days | Assessed using Timeline Follow Back (TLFB) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Brief Electronic Intervention: The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so. | 20 |
| Attention-matched Control Attention-Matched Control: Participants will view a video clip on general health promotion that is a similar length as the intervention arm. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intervention | Total | Attention-matched Control |
|---|---|---|---|
| Age, Continuous | 27.7 Years STANDARD_DEVIATION 8.3 | 28.3 Years STANDARD_DEVIATION 9.1 | 28.8 Years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 36 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 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 | 15 Participants | 28 Participants | 13 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 40 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Average Number of Drinks Per Drinking Day
Assessed using Timeline Follow Back (TLFB)
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Post-test Counseling (Control) | Average Number of Drinks Per Drinking Day | 4.73 Drinks | Standard Deviation 2.3 |
| Brief Web-based Intervention | Average Number of Drinks Per Drinking Day | 4.54 Drinks | Standard Deviation 1.6 |
Primary
Number of Condomless Anal Sex Events, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Post-test Counseling (Control) | Number of Condomless Anal Sex Events, Past 30 Days | 1.06 Events | Standard Deviation 1.6 |
| Brief Web-based Intervention | Number of Condomless Anal Sex Events, Past 30 Days | 1.08 Events | Standard Deviation 1.3 |
Primary
Number of Drinking Days, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Post-test Counseling (Control) | Number of Drinking Days, Past 30 Days | 10.8 Days | Standard Deviation 6.9 |
| Brief Web-based Intervention | Number of Drinking Days, Past 30 Days | 7.04 Days | Standard Deviation 5 |
Primary
Number of Heavy Drinking Days (5 or More), Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Post-test Counseling (Control) | Number of Heavy Drinking Days (5 or More), Past 30 Days | 3.83 Days | Standard Deviation 3.6 |
| Brief Web-based Intervention | Number of Heavy Drinking Days (5 or More), Past 30 Days | 2.67 Days | Standard Deviation 1.8 |
Primary
Number of New Sex Partners, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB)
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Post-test Counseling (Control) | Number of New Sex Partners, Past 30 Days | 2.53 New partners | Standard Deviation 3.6 |
| Brief Web-based Intervention | Number of New Sex Partners, Past 30 Days | 1.37 New partners | Standard Deviation 1.2 |