Trial Outcomes & Findings for Alcohol and Sex Risk Intervention for MSM Supplement (NCT NCT03522948)
NCT ID: NCT03522948
Last Updated: 2021-02-11
Results Overview
3-item modification of Client Satisfaction Questionnaire. Three 5-point Likert scale is used to assess "intervention satisfaction" \[very dissatisfied - very satisfied\]; degree to which intervention helped alcohol use \[no effect to helped a great deal\], and intervention helped sexual behavior decisions \[no effect - helped a great deal\]. Mean scale range is 1-5. Higher scores reflect a better outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Participants complete the measure 5-6 weeks following baseline.
Results posted on
2021-02-11
Participant Flow
Participant milestones
| Measure |
Open Pilot
The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.
Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
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|---|---|
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Overall Study
STARTED
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8
|
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Open Pilot
The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.
Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
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|---|---|
|
Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Alcohol and Sex Risk Intervention for MSM Supplement
Baseline characteristics by cohort
| Measure |
Open Pilot
n=8 Participants
The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.
Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
|
|---|---|
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Age, Continuous
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24.0 years
STANDARD_DEVIATION 2.80 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Participants complete the measure 5-6 weeks following baseline.3-item modification of Client Satisfaction Questionnaire. Three 5-point Likert scale is used to assess "intervention satisfaction" \[very dissatisfied - very satisfied\]; degree to which intervention helped alcohol use \[no effect to helped a great deal\], and intervention helped sexual behavior decisions \[no effect - helped a great deal\]. Mean scale range is 1-5. Higher scores reflect a better outcome
Outcome measures
| Measure |
Open Pilot
n=7 Participants
The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.
Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
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|---|---|
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Intervention Satisfaction Scale
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4.25 units on a scale
Standard Deviation 0.05
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SECONDARY outcome
Timeframe: Participants report frequency of heavy drinking episodes as part of the AUDIT-C questionnaire. The question is presented at baseline and at follow-up which occurs 5-6 weeks following baseline. There is no timeframe specified in the question itself.Population: computer processing error lead to omission of 2 participants for this analysis
This measure is a 5-point Likert scale item which asks participants to report "How often do you have six or more drinks on one occasion?" Response options range from "never" to "daily or almost daily." This measure is completed at baseline and 5 to 6 weeks after baseline. Higher scores reflect worse outcomes. Responses reflect current perceptions of past drinking. Range 0-4
Outcome measures
| Measure |
Open Pilot
n=5 Participants
The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.
Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
|
|---|---|
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Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test
Baseline
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2.60 score on a scale
Standard Deviation 0.55
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Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test
Follow-up
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1.60 score on a scale
Standard Deviation 0.55
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SECONDARY outcome
Timeframe: Frequency of condomless anal intercourse (CAI) over the past 3 months at baseline (divided by 3 for monthly CAI) and rate frequency of condomless anal intercourse over the past month at follow-up assessment that occurs 5-6 weeks following baseline.Single item measure of number of times that individual engaged in unprotected intercourse. Range is 0-30 for baseline (reflecting 0-90 range for past 3 months divided by 3) and range is 0-30 for follow-up. Higher scores reflect a worse outcome.
Outcome measures
| Measure |
Open Pilot
n=7 Participants
The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.
Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
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|---|---|
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Frequency of Condomless Anal Intercourse.
Baseline Monthly CAI
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2.67 condomless anal intercourse
Standard Deviation 1.35
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Frequency of Condomless Anal Intercourse.
Follow-Up past Month CAI
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1.29 condomless anal intercourse
Standard Deviation 1.38
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POST_HOC outcome
Timeframe: This measure was taken at baseline and at follow-up. There is no specific timeframe indicated in the measure as it is used to indicate current goal cognitions. The measure is completed at baseline and 5 to 6 weeks following baseline.This GSAB battery consists of 4 subscales comprised of 4 Likert-scale items each ranging from 0-4. The subscales indicate value, self-efficacy, monitoring and planning related to the behavior change goal of reducing alcohol use. The mean subscale range is from 0-16. Higher scores reflect better self-regulatory outcomes.
Outcome measures
| Measure |
Open Pilot
n=7 Participants
The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.
Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
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|---|---|
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Reducing Alcohol Use".
Baseline GSAB Reducing Alcohol -Value
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5.71 units on a scale
Standard Deviation 2.69
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Reducing Alcohol Use".
Follow-up GSAB Reducing Alcohol Value
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10 units on a scale
Standard Deviation 3.61
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Reducing Alcohol Use".
Baseline GSAB Reducing Alcohol Self-Efficacy
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12.14 units on a scale
Standard Deviation 2.48
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Reducing Alcohol Use".
Follow-up GSAB Reducing Alcohol Self-Efficacy
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13 units on a scale
Standard Deviation 2.71
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Reducing Alcohol Use".
Baseline GSAB Reducing Alcohol Self-Monitoring
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6.14 units on a scale
Standard Deviation 4.14
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Reducing Alcohol Use".
Follow-up GSAB Reducing Alcohol Self-Monitoring
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9.71 units on a scale
Standard Deviation 2.63
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Reducing Alcohol Use".
Baseline GSAB Reducing Alcohol Planning
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4.86 units on a scale
Standard Deviation 4.26
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Reducing Alcohol Use".
Follow-up GSAB Reducing Alcohol Planning
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8.14 units on a scale
Standard Deviation 3.24
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POST_HOC outcome
Timeframe: This measure was taken at baseline and at follow-up. There is no specific timeframe indicated on the questions as the measure indicates current goal cognitions. The measure is completed at baseline and 5 to 6 weeks following baseline.This GSAB battery consists of 4 subscales comprised of 4 Likert scale items each ranging from 0-4. Items are summed to create subscale scores. The subscales indicate value, self-efficacy, planning, and monitoring related to the behavior change goal. The mean subscale range is from 0-16. Higher scores reflect better self-regulatory outcomes
Outcome measures
| Measure |
Open Pilot
n=7 Participants
The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.
Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
|
|---|---|
|
Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Using Condoms Every Time You Have Sex With a Partner of Unknown HIV Status".
Baseline GSAB Condom Value
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11.14 units on a scale
Standard Deviation 5.52
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Using Condoms Every Time You Have Sex With a Partner of Unknown HIV Status".
Follow-up GSAB Condom Value
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13.71 units on a scale
Standard Deviation 2.21
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Using Condoms Every Time You Have Sex With a Partner of Unknown HIV Status".
Baseline GSAB Condom Self-Efficacy
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11.57 units on a scale
Standard Deviation 3.36
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Using Condoms Every Time You Have Sex With a Partner of Unknown HIV Status".
Follow-up GSAB Condom Self-Efficacy
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13.43 units on a scale
Standard Deviation 2.70
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Using Condoms Every Time You Have Sex With a Partner of Unknown HIV Status".
Baseline GSAB Condom Self-Monitoring
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7.29 units on a scale
Standard Deviation 4.96
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Using Condoms Every Time You Have Sex With a Partner of Unknown HIV Status".
Follow-up GSAB Condom Self-Monitoring
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11.14 units on a scale
Standard Deviation 3.85
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Using Condoms Every Time You Have Sex With a Partner of Unknown HIV Status".
Baseline GSAB Condom Planning
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7.43 units on a scale
Standard Deviation 5.38
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Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of "Using Condoms Every Time You Have Sex With a Partner of Unknown HIV Status".
Follow-up GSAB Condom Planning
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11.43 units on a scale
Standard Deviation 3.64
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Adverse Events
Open Pilot
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place