Heavy Drinking and Sexual Risk Behavior
Conditions
Keywords
heavy drinking, sexual risk behavior
Brief summary
Open pilot trial to test the feasibility and efficacy of a brief intervention with text messaging to reduce sexual risk behavior and heavy drinking among MSM
Detailed description
This study seeks to develop and provide an initial test of a brief intervention to reduce alcohol use and sex risk behavior among among men who have sex with men. The study seeks to recruit MSM who are non-monogamous, have engaged in unprotected anal intercourse over the past 3 months, and who have engaged in heavy drinking defined as \> 14 drinks per week or at least 1 heavy drinking episode (5+ drinks on a single occasion) in the past month. All participants will complete baseline measures about past month behavior and if eligible will be assigned to the intervention condition. This intervention consists of a single brief in-person intervention coupled with 4 weeks of text messaging related to individualized goals about alcohol use and sexual behavior. Follow-up assessments are scheduled for within 1 week of completion of the text messaging component of the intervention. Primary outcomes are feasibility and acceptability of the intervention and message components. Secondary outcomes are changes in frequency of unprotected intercourse and heavy drinking episodes.
Interventions
BEHAVIORALBrief 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
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston University Charles River Campus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open pilot study to test feasibility of intervention
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Non-monogamous bisexual/gay male with Kinsey score indicating mainly homosexual identification, heavy drinking, UAI in past 3 months. \-
Exclusion criteria
HIV+ Past or current tx for alcohol use (past 3 years), bipolar disorder or schizophrenia Current psychiatric treatment Medications contraindicated by alcohol Medical conditions contraindicated by alcohol Substance specific ASSIST scores of 27 or greater \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Satisfaction Scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test | 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. | 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 |
| Frequency of Condomless Anal Intercourse. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Open Pilot |
|---|---|
| Age, Continuous | 24.0 years STANDARD_DEVIATION 2.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Intervention Satisfaction Scale
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
Time frame: Participants complete the measure 5-6 weeks following baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Pilot | Intervention Satisfaction Scale | 4.25 units on a scale | Standard Deviation 0.05 |
Secondary
Frequency of Condomless Anal Intercourse.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Pilot | Frequency of Condomless Anal Intercourse. | Baseline Monthly CAI | 2.67 condomless anal intercourse | Standard Deviation 1.35 |
| Open Pilot | Frequency of Condomless Anal Intercourse. | Follow-Up past Month CAI | 1.29 condomless anal intercourse | Standard Deviation 1.38 |
p-value: 0.23t-test, 2 sided
Secondary
Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Pilot | Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test | Baseline | 2.60 score on a scale | Standard Deviation 0.55 |
| Open Pilot | Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test | Follow-up | 1.60 score on a scale | Standard Deviation 0.55 |
Comparison: within-subject t-testp-value: 0.03t-test, 2 sided
Post Hoc
Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Pilot | Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use. | Baseline GSAB Reducing Alcohol Planning | 4.86 units on a scale | Standard Deviation 4.26 |
| Open Pilot | Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use. | Follow-up GSAB Reducing Alcohol Planning | 8.14 units on a scale | Standard Deviation 3.24 |
| Open Pilot | Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use. | Baseline GSAB Reducing Alcohol -Value | 5.71 units on a scale | Standard Deviation 2.69 |
| Open Pilot | Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use. | Follow-up GSAB Reducing Alcohol Value | 10 units on a scale | Standard Deviation 3.61 |
| Open Pilot | Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use. | Baseline GSAB Reducing Alcohol Self-Efficacy | 12.14 units on a scale | Standard Deviation 2.48 |
| Open Pilot | Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use. | Follow-up GSAB Reducing Alcohol Self-Efficacy | 13 units on a scale | Standard Deviation 2.71 |
| Open Pilot | Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use. | Baseline GSAB Reducing Alcohol Self-Monitoring | 6.14 units on a scale | Standard Deviation 4.14 |
| Open Pilot | Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for Behavior Goal of Reducing Alcohol Use. | Follow-up GSAB Reducing Alcohol Self-Monitoring | 9.71 units on a scale | Standard Deviation 2.63 |
Comparison: GSAB self-efficacyp-value: <0.0595% CI: [-0.69, 2.41]t-test, 2 sided
Post Hoc
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.
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Pilot | 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 | 11.14 units on a scale | Standard Deviation 5.52 |
| Open Pilot | 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 | 13.71 units on a scale | Standard Deviation 2.21 |
| Open Pilot | 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 | 11.57 units on a scale | Standard Deviation 3.36 |
| Open Pilot | 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 | 13.43 units on a scale | Standard Deviation 2.7 |
| Open Pilot | 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 | 7.29 units on a scale | Standard Deviation 4.96 |
| Open Pilot | 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 | 11.14 units on a scale | Standard Deviation 3.85 |
| Open Pilot | 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 | 7.43 units on a scale | Standard Deviation 5.38 |
| Open Pilot | 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 | 11.43 units on a scale | Standard Deviation 3.64 |
Comparison: Test of GSAB self-efficacy subscale for condom usep-value: <0.0595% CI: [0.31, 3.41]t-test, 2 sided