MI&TXT4MSM: MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM

• Sponsor: Boston University Charles River Campus (Other)
• Overall Status: Completed
• CT.gov ID: NCT03755661
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. The intervention consists of an "in-person" brief motivational intervention followed by a series of text messages related to alcohol and sexual risk reduction. The primary outcome is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.

Condition or Disease	Intervention/Treatment	Phase
Alcohol; Harmful Use; Sex, Unsafe	Behavioral: MI&TXT4MSM	N/A

Detailed Description

This is a pilot study designed to provide initial effect size estimates for an intervention addressing hazardous drinking and sexual risk behavior among men who have sex with men. In this study, 24 participants initially recruited through advertisements in the community will be randomly assigned to either Assessment Only or Intervention Condition. Those in the Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments. Those in the intervention condition will receive a 50-min brief intervention in person followed by 6 weeks of tailored app-based messaging to support the intervention content, then another 6-weeks of goal setting text-based messages. Data will be analyzed to determine effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants are randomly assigned to one of two groupsParticipants are randomly assigned to one of two groups
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcomes assessor is not provided with randomization information for the subjects
• Primary Purpose: Prevention
• Official Title: Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement
• Actual Study Start Date: Oct 9, 2018
• Actual Primary Completion Date: Mar 9, 2020
• Actual Study Completion Date: Mar 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention This intervention arm is a combined in-person text messaging intervention	Behavioral: MI&TXT4MSM; brief in-person intervention followed by text messaging
No Intervention: Assessment Only Control The is the assessment only comparison condition

Outcome Measures

Primary Outcome Measures

1. Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion) [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

2. 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] [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

3. Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month [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

Secondary Outcome Measures

1. Young Adult Alcohol Consequences Questionnaire [Alcohol] [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

Other Outcome Measures

1. Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above. [6 -weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• At least 1 heavy drinking episode or consumption of more than 14 drinks per week over the past month

• At least 1 condomless anal sex episode in past 3 months

• Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least "equally heterosexual and homosexual". Scale ranges from 0 (exclusively heterosexual) to 6 (exclusively homosexual)

Exclusion Criteria:

• Alcohol treatment currently or in past 3 years

• Bipolar disorder or schizophrenia treatment

• Exclusive monogamous relationship

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston University Department of Psychological and Brain Science	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Boston University Charles River Campus
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 17, 2019

More Information

Publications

None provided.

• Responsible Party: Tibor Palfai, Professor, Boston University Charles River Campus
• ClinicalTrials.gov Identifier: NCT03755661
• Other Study ID Numbers: 3468a; 3R01AA022301-02S1
• First Posted: Nov 28, 2018
• Last Update Posted: May 6, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details	Participants were recruited through social media ads and the study was conducted at a university laboratory that is affiliated with a psychological services clinic
Pre-assignment Detail	Eligibility was confirmed at the in-person session. Randomization occurred following baseline assessment

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

Baseline Characteristics

Arm/Group Title	Intervention	Assessment Only Control	Total
Arm/Group Description	This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging	The is the assessment only comparison condition	Total of all reporting groups
Overall Participants	12	12	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.18 (7.26)	30.75 (7.79)	30.48 (7.36)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	12 100%	12 100%	24 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 25%	2 16.7%	5 20.8%
Not Hispanic or Latino	9 75%	10 83.3%	19 79.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 16.7%	2 8.3%
Asian	1 8.3%	0 0%	1 4.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	11 91.7%	9 75%	20 83.3%
More than one race	0 0%	1 8.3%	1 4.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Assessment Only Control
Arm/Group Description	This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging	The is the assessment only comparison condition
Measure Participants	11	12
Mean (Standard Deviation) [heavy drinking episodes]	3.09 (3.62)	5.33 (3.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Assessment Only Control
	Comments	pilot study to calculate effect size, study is not powered to detect significant group differences
	Type of Statistical Test	Other
	Comments	pilot data to estimate effect size f-squared as the parameter as primary outcome
Statistical Test of Hypothesis	p-Value	.048
	Comments	provide inferential statistics for data completion. Study is not designed to detect significant differences between groups
	Method	Regression, Linear
	Comments	R-square change = .12; F-change (1, 20) = 4.44
Other Statistical Analysis		Computed f-squared as effect size estimate where baseline value of heavy drinking episodes entered in step 1 and condition in step 2 f- squared = .22

2. Primary Outcome

Title	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]
Description	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
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Assessment Only Control
Arm/Group Description	This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging	The is the assessment only comparison condition
Measure Participants	11	12
Mean (Standard Deviation) [condomless anal intercourse episodes]	1.54 (2.46)	4.33 (6.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Assessment Only Control
	Comments	pilot trial to compute effect size estimate
	Type of Statistical Test	Superiority
	Comments	The main outcome variable is f-squared as an estimate of differences between conditions controlling for baseline value. A statistical test is provided only for completeness as this study is not powered to detect significant effects
Statistical Test of Hypothesis	p-Value	.34
	Comments	F-change (1, 20) = 0.97
	Method	Regression, Linear
	Comments
Other Statistical Analysis		Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04

3. Primary Outcome

Title	Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Assessment Only Control
Arm/Group Description	This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging	The is the assessment only comparison condition
Measure Participants	11	12
Mean (Standard Deviation) [Average number of drinks per week]	9.45 (6.57)	11.58 (6.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Assessment Only Control
	Comments
	Type of Statistical Test	Superiority
	Comments	This is a pilot trial to estimate effect sizes and not powered to detect significant differences
Statistical Test of Hypothesis	p-Value	.20
	Comments	data provided for completeness, not powered to test differences
	Method	Regression, Linear
	Comments	F-change (1, 20) = 1.80
Other Statistical Analysis		Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .058

4. Secondary Outcome

Title	Young Adult Alcohol Consequences Questionnaire [Alcohol]
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Assessment Only Control
Arm/Group Description	This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging	The is the assessment only comparison condition
Measure Participants	11	12
Mean (Standard Deviation) [score on a scale]	6.45 (6.62)	9.41 (7.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Assessment Only Control
	Comments	Pilot trial not powered to detect significant group differences
	Type of Statistical Test	Superiority
	Comments	Pilot trial not powered to detect significant group differences. Data from analyses presented for completeness. Primary outcome is effect size estimates
Statistical Test of Hypothesis	p-Value	.19
	Comments
	Method	Regression, Linear
	Comments	F-change (1, 20) = 1.83
Other Statistical Analysis		Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .048

5. Other Pre-specified Outcome

Title	Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.
Description	The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome
Time Frame	6 -weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Assessment Only Control
Arm/Group Description	This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging	The is the assessment only comparison condition
Measure Participants	11	11
Mean (Standard Deviation) [condomless anal intercourse episodes]	0.91 (0.94)	1.63 (1.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Assessment Only Control
	Comments	Not powered to test significant differences. provide data on effect size estimate below
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.26
	Comments	F-change (1, 19) = 1.34
	Method	Regression, Linear
	Comments
Other Statistical Analysis		Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04

Adverse Events

Time Frame	Adverse event data were collected up to the 6 month outcome following enrollment. This corresponds to the time period from initial enrollment to study completion
Arm/Group Title	Intervention		Assessment Only Control
Arm/Group Description	This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging No adverse events		The is the assessment only comparison condition No adverse events
All Cause Mortality
	Intervention		Assessment Only Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Intervention		Assessment Only Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Assessment Only Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.