An interventional study of Brief Electronic Intervention and Attention-Matched Control in HIV Infections and Alcohol Abuse, sponsored by Brown University. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Brown University · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Behavioral: Brief Electronic Intervention
Behavioral: Attention-Matched Control
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.
Participants will view a video clip on general health promotion that is a similar length as the intervention arm.
Number of New Sex Partners, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB)
Time frame: Past 30 days
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
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
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
Average Number of Drinks Per Drinking Day
Assessed using Timeline Follow Back (TLFB)
Time frame: Past 30 days
| Milestone | Standard Post-test Counseling (Control) | Brief Web-based Intervention |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 19 |
| Not completed | 0 | 1 |
Assessed via self-report using Timeline Follow Back (TLFB)
| New partners | Standard Post-test Counseling (Control) | Brief Web-based Intervention |
|---|---|---|
| Number of New Sex Partners, Past 30 Days | 2.53 ± 3.6 | 1.37 ± 1.2 |
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.
| Events | Standard Post-test Counseling (Control) | Brief Web-based Intervention |
|---|---|---|
| Number of Condomless Anal Sex Events, Past 30 Days | 1.06 ± 1.6 | 1.08 ± 1.3 |
Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30
| Days | Standard Post-test Counseling (Control) | Brief Web-based Intervention |
|---|---|---|
| Number of Drinking Days, Past 30 Days | 10.8 ± 6.9 | 7.04 ± 5.0 |
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.
| Days | Standard Post-test Counseling (Control) | Brief Web-based Intervention |
|---|---|---|
| Number of Heavy Drinking Days (5 or More), Past 30 Days | 3.83 ± 3.6 | 2.67 ± 1.8 |
Assessed using Timeline Follow Back (TLFB)
| Drinks | Standard Post-test Counseling (Control) | Brief Web-based Intervention |
|---|---|---|
| Average Number of Drinks Per Drinking Day | 4.73 ± 2.3 | 4.54 ± 1.6 |
Collected over 3 months (the duration of the study period for all participants).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Post-test Counseling (Control) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Brief Web-based Intervention | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(Years) | Intervention | Attention-matched Control | Total |
|---|---|---|---|
| Mean | 27.7 ± 8.3 | 28.8 ± 9.9 | 28.3 ± 9.1 |
| Sex: Female, Male(Participants) | Intervention | Attention-matched Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 20 | 20 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Attention-matched Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 1 | 4 |
| Not Hispanic or Latino | 17 | 19 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention | Attention-matched Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 15 | 13 | 28 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention | Attention-matched Control | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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Plan to share: No
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Brown University