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Trial Outcomes & Findings for MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM (NCT NCT03755661)

NCT ID: NCT03755661

Last Updated: 2021-05-06

Results Overview

Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion \[no scale\]. Higher score is a worse outcome, range 0-30

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

30 days

Results posted on

2021-05-06

Participant Flow

Participants were recruited through social media ads and the study was conducted at a university laboratory that is affiliated with a psychological services clinic

Eligibility was confirmed at the in-person session. Randomization occurred following baseline assessment

Participant milestones

Participant milestones
Measure
Intervention
This intervention arm is a combined in-person text messaging intervention MI\&TXT4MSM: brief in-person intervention followed by text messaging
Assessment Only Control
This condition includes only assessment measures. It is used as the comparison condition to the intervention under study.
Overall Study
STARTED
12
12
Overall Study
COMPLETED
11
12
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention
This intervention arm is a combined in-person text messaging intervention MI\&TXT4MSM: brief in-person intervention followed by text messaging
Assessment Only Control
This condition includes only assessment measures. It is used as the comparison condition to the intervention under study.
Overall Study
Lost to Follow-up
1
0

Baseline Characteristics

MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=12 Participants
This intervention arm is a combined in-person text messaging intervention MI\&TXT4MSM: brief in-person intervention followed by text messaging
Assessment Only Control
n=12 Participants
The is the assessment only comparison condition
Total
n=24 Participants
Total of all reporting groups
Age, Continuous
30.18 years
STANDARD_DEVIATION 7.26 • n=5 Participants
30.75 years
STANDARD_DEVIATION 7.79 • n=7 Participants
30.48 years
STANDARD_DEVIATION 7.36 • 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
12 Participants
n=5 Participants
12 Participants
n=7 Participants
24 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
10 Participants
n=7 Participants
19 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
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 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
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
9 Participants
n=7 Participants
20 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 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
12 Participants
n=5 Participants
12 Participants
n=7 Participants
24 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion \[no scale\]. Higher score is a worse outcome, range 0-30

Outcome measures

Outcome measures
Measure
Intervention
n=11 Participants
This intervention arm is a combined in-person text messaging intervention MI\&TXT4MSM: brief in-person intervention followed by text messaging
Assessment Only Control
n=12 Participants
The is the assessment only comparison condition
Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
3.09 heavy drinking episodes
Standard Deviation 3.62
5.33 heavy drinking episodes
Standard Deviation 3.42

PRIMARY outcome

Timeframe: 90 days

Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days \[no scale\] Range from 0-90

Outcome measures

Outcome measures
Measure
Intervention
n=11 Participants
This intervention arm is a combined in-person text messaging intervention MI\&TXT4MSM: brief in-person intervention followed by text messaging
Assessment Only Control
n=12 Participants
The is the assessment only comparison condition
Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]
1.54 condomless anal intercourse episodes
Standard Deviation 2.46
4.33 condomless anal intercourse episodes
Standard Deviation 6.12

PRIMARY outcome

Timeframe: 30 days

Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome

Outcome measures

Outcome measures
Measure
Intervention
n=11 Participants
This intervention arm is a combined in-person text messaging intervention MI\&TXT4MSM: brief in-person intervention followed by text messaging
Assessment Only Control
n=12 Participants
The is the assessment only comparison condition
Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month
9.45 Average number of drinks per week
Standard Deviation 6.57
11.58 Average number of drinks per week
Standard Deviation 6.14

SECONDARY outcome

Timeframe: 30 days

Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome

Outcome measures

Outcome measures
Measure
Intervention
n=11 Participants
This intervention arm is a combined in-person text messaging intervention MI\&TXT4MSM: brief in-person intervention followed by text messaging
Assessment Only Control
n=12 Participants
The is the assessment only comparison condition
Young Adult Alcohol Consequences Questionnaire [Alcohol]
6.45 score on a scale
Standard Deviation 6.62
9.41 score on a scale
Standard Deviation 7.41

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 -weeks

The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome

Outcome measures

Outcome measures
Measure
Intervention
n=11 Participants
This intervention arm is a combined in-person text messaging intervention MI\&TXT4MSM: brief in-person intervention followed by text messaging
Assessment Only Control
n=11 Participants
The is the assessment only comparison condition
Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.
0.91 condomless anal intercourse episodes
Standard Deviation 0.94
1.63 condomless anal intercourse episodes
Standard Deviation 1.56

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Assessment Only Control

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

LaNeia Thomas

Boston University

Phone: 617-358-6346

Results disclosure agreements

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