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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01AA022301-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open pilot | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Participants complete the measure 5-6 weeks following baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Non-monogamous bisexual/gay male with Kinsey score indicating mainly homosexual identification, heavy drinking, UAI in past 3 months.
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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
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| Name | Affiliation | Role |
|---|---|---|
| Tibor Palfai, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Participants complete the measure 5-6 weeks following baseline. |
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through study completion, up to six weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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The focus of the intervention was feasibility and acceptability, not results of inferential statistical analysis as this is a small sample in an open pilot
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tibor Palfai | Boston University | 617-353-9345 | palfai@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2021 | Jan 24, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Open pilot study to test feasibility of intervention
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| 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. |
| 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. | 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | computer processing error lead to omission of 2 participants for this analysis | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | 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. |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| 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 | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| 0 |
| 8 |
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| 8 |
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| 8 |
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| Follow-up GSAB Reducing Alcohol Self-Efficacy |
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| Baseline GSAB Reducing Alcohol Self-Monitoring |
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| Follow-up GSAB Reducing Alcohol Self-Monitoring |
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| Baseline GSAB Reducing Alcohol Planning |
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| Follow-up GSAB Reducing Alcohol Planning |
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| Title | Measurements |
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| Follow-up GSAB Condom Self-Efficacy |
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| Baseline GSAB Condom Self-Monitoring |
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| Follow-up GSAB Condom Self-Monitoring |
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| Baseline GSAB Condom Planning |
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| Follow-up GSAB Condom Planning |
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