Alcohol; Harmful Use, Sex, Unsafe
Conditions
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.
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.
Interventions
BEHAVIORALMI&TXT4MSM
brief in-person intervention followed by text messaging
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor is not provided with randomization information for the subjects
Intervention model description
Participants are randomly assigned to one of two groups
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
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 details
Eligibility was confirmed at the in-person session. Randomization occurred following baseline assessment
Participants by arm
| Arm | Count |
|---|---|
| Intervention This intervention arm is a combined in-person text messaging intervention
MI&TXT4MSM: brief in-person intervention followed by text messaging | 12 |
| Assessment Only Control The is the assessment only comparison condition | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention | Total | Assessment Only Control |
|---|---|---|---|
| Age, Continuous | 30.18 years STANDARD_DEVIATION 7.26 | 30.48 years STANDARD_DEVIATION 7.36 | 30.75 years STANDARD_DEVIATION 7.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 19 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 20 Participants | 9 Participants |
| Region of Enrollment United States | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 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 |
| Assessment Only Control | Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month | 11.58 Average number of drinks per week | Standard Deviation 6.14 |
p-value: 0.2Regression, Linear
Primary
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]
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 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 |
| Assessment Only Control | 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] | 4.33 condomless anal intercourse episodes | Standard Deviation 6.12 |
Comparison: pilot trial to compute effect size estimatep-value: 0.34Regression, Linear
Primary
Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion) | 3.09 heavy drinking episodes | Standard Deviation 3.62 |
| Assessment Only Control | Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion) | 5.33 heavy drinking episodes | Standard Deviation 3.42 |
Comparison: pilot study to calculate effect size, study is not powered to detect significant group differencesp-value: 0.048Regression, Linear
Secondary
Young Adult Alcohol Consequences Questionnaire [Alcohol]
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Young Adult Alcohol Consequences Questionnaire [Alcohol] | 6.45 score on a scale | Standard Deviation 6.62 |
| Assessment Only Control | Young Adult Alcohol Consequences Questionnaire [Alcohol] | 9.41 score on a scale | Standard Deviation 7.41 |
Comparison: Pilot trial not powered to detect significant group differencesp-value: 0.19Regression, Linear
Other Pre-specified
Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.
The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome
Time frame: 6 -weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above. | 0.91 condomless anal intercourse episodes | Standard Deviation 0.94 |
| Assessment Only Control | Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above. | 1.63 condomless anal intercourse episodes | Standard Deviation 1.56 |
Comparison: Not powered to test significant differences. provide data on effect size estimate belowp-value: 0.26Regression, Linear