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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01AA022301-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This intervention arm is a combined in-person text messaging intervention |
|
| Assessment Only Control | No Intervention | The is the assessment only comparison condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI&TXT4MSM | Behavioral | brief in-person intervention followed by text messaging |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| 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 | 90 days |
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 -weeks |
Inclusion Criteria:
Exclusion Criteria:
identify as male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Department of Psychological and Brain Science | Boston | Massachusetts | 02215 | United States |
Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review
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Data will be available one year after the trial end. They will be available for investigators to request up to 5 years following their release
Researcher with specified analytic request.
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Eligibility was confirmed at the in-person session. Randomization occurred following baseline assessment
Participants were recruited through social media ads and the study was conducted at a university laboratory that is affiliated with a psychological services clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging |
| FG001 | Assessment Only Control | This condition includes only assessment measures. It is used as the comparison condition to the intervention under study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging |
| BG001 | Assessment Only Control |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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 | Posted | Mean | Standard Deviation | heavy drinking episodes | 30 days |
|
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
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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 | Intervention | This intervention arm is a combined in-person text messaging intervention MI&TXT4MSM: brief in-person intervention followed by text messaging No adverse events |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| LaNeia Thomas | Boston University | 617-358-6346 | laneia@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 | Apr 17, 2019 | Apr 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047568 | Unsafe Sex |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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Participants are randomly assigned to one of two groups
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The outcomes assessor is not provided with randomization information for the subjects
The is the assessment only comparison condition
| BG002 | Total | Total of all reporting groups |
| 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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| Region of Enrollment | Count of Participants | Participants |
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|
|
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| 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 | Posted | Mean | Standard Deviation | condomless anal intercourse episodes | 90 days |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | Average number of drinks per week | 30 days |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
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|
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| 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 | Posted | Mean | Standard Deviation | condomless anal intercourse episodes | 6 -weeks |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Assessment Only Control | The is the assessment only comparison condition No adverse events | 0 | 12 | 0 | 12 | 0 | 12 |
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