Trial Outcomes & Findings for Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing (NCT NCT03435783)

NCT ID: NCT03435783

Last Updated: 2019-04-23

Results Overview

Assessed via self-report using Timeline Follow Back (TLFB)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Past 30 days
• Results posted on: 2019-04-23

Participant Flow

Participant milestones

Measure	Standard Post-test Counseling (Control) Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.	Brief Web-based Intervention This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing

Baseline characteristics by cohort

Measure	Intervention n=20 Participants 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.	Attention-matched Control n=20 Participants Attention-Matched Control: Participants will view a video clip on general health promotion that is a similar length as the intervention arm.	Total n=40 Participants Total of all reporting groups
Age, Continuous	27.7 Years STANDARD_DEVIATION 8.3 • n=5 Participants	28.8 Years STANDARD_DEVIATION 9.9 • n=7 Participants	28.3 Years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Past 30 days

Assessed via self-report using Timeline Follow Back (TLFB)

Outcome measures

Measure	Standard Post-test Counseling (Control) n=20 Participants Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.	Brief Web-based Intervention n=20 Participants This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
Number of New Sex Partners, Past 30 Days	2.53 New partners Standard Deviation 3.6	1.37 New partners Standard Deviation 1.2

PRIMARY outcome

Timeframe: Past 30 days

Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.

Outcome measures

Measure	Standard Post-test Counseling (Control) n=20 Participants Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.	Brief Web-based Intervention n=20 Participants This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
Number of Condomless Anal Sex Events, Past 30 Days	1.06 Events Standard Deviation 1.6	1.08 Events Standard Deviation 1.3

PRIMARY outcome

Timeframe: Past 30 days

Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30

Outcome measures

Measure	Standard Post-test Counseling (Control) n=20 Participants Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.	Brief Web-based Intervention n=20 Participants This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
Number of Drinking Days, Past 30 Days	10.8 Days Standard Deviation 6.9	7.04 Days Standard Deviation 5.0

PRIMARY outcome

Timeframe: Past 30 days

Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.

Outcome measures

Measure	Standard Post-test Counseling (Control) n=20 Participants Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.	Brief Web-based Intervention n=20 Participants This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
Number of Heavy Drinking Days (5 or More), Past 30 Days	3.83 Days Standard Deviation 3.6	2.67 Days Standard Deviation 1.8

PRIMARY outcome

Timeframe: Past 30 days

Assessed using Timeline Follow Back (TLFB)

Outcome measures

Measure	Standard Post-test Counseling (Control) n=20 Participants Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.	Brief Web-based Intervention n=20 Participants This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
Average Number of Drinks Per Drinking Day	4.73 Drinks Standard Deviation 2.3	4.54 Drinks Standard Deviation 1.6

Adverse Events

Standard Post-test Counseling (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brief Web-based Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tyler Wray

Brown University School of Public Health

Phone: 401-863-6659

Email: tyler_wray@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place