Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months.
Heavy drinking in HIV-infected patients can lead to low antiretroviral therapy adherence and poor virologic control, greater sexual risk taking, increased risk of liver disease, and decreased cognitive function. Therefore, reductions in drinking may have particularly positive and widespread effects in HIV-infected patients. Men who have sex with men (MSM) continue to represent the majority of new HIV infections, and HIV-infected MSM have rates of hazardous drinking as high as 33%. Therefore, developing and testing interventions to reduce heavy drinking in HIV-infected MSM is a very high public health priority. There have been relatively few alcohol interventions tested that focus on MSM, and only two have addressed drinking in HIV-infected MSM. Although recent studies indicate that behavioral interventions can reduce heavy drinking in HIV-infected patients, much remains unknown about the efficacy of different approaches to behavioral intervention and their unique and combined effects. The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months. BA and MI will be delivered by a core set of interventionists from a central location using a webcam-enabled telemedicine system, which can facilitate larger-scale implementation. The design will allow us to test the hypothesis that MI compared to BA, ITM compared to no ITM, and EI compared to no EI, will result in significantly greater reductions in number of alcoholic drinks consumed and number of heavy drinking days at 6- and 12-month follow-ups. Secondary outcomes include engagement in unprotected anal intercourse, ART adherence and viral suppression, CD4 cell count, liver function tests, and neurocognitive function. We also will test the hypothesis that the effects of MI, ITM, and EI on drinking will be moderated by alcohol use disorder status and readiness to change drinking such that these interventions will be relatively more efficacious in those with a current disorder and those with low readiness. The study will provide crucial evidence regarding which intervention approaches, alone or in combination, are likely to be most efficient to implement on a large scale in HIV care settings.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI | Active Comparator | Motivational interviewing focused on reducing alcohol use, delivered by videoconferencing. |
|
| BA | Active Comparator | Brief Advice to reduce drinking delivered by videoconferencing |
|
| MI + ITM | Active Comparator | Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use |
|
| BA + ITM | Active Comparator | Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use |
|
| MI + ITM + EI | Active Comparator | Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational intervention | Behavioral | Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Drinks Per Week at 6 Months | Average number of alcoholic drinks consumed per week assessed at 6 months. Covers the period of 30 days prior to the assessment. | Past 30 days |
| Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | Average number of alcoholic drinks consumed per week assessed at 12 months. Covers the period of 30 days prior to the assessment. | Past 30 days |
| Number of Heavy Drinking Days at 6 Months | Number of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 months | Past 30 days |
| Number of Heavy Drinking Days at 12 Months | Number of days drinking 5 or more alcoholic drinks | Past 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenway Health | Boston | Massachusetts | United States | |||
| Center for Alcohol and Addiction Studies, Brown University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39266891 | Derived | Kahler CW, Surace A, Liu T, Pantalone DW, Mastroleo NR, Yan Y, Wray TB, Mayer KH, Monti PM. Efficacy of Behavioral Intervention, Text Messaging, and Extended Intervention to Address Alcohol Misuse in Sexual Minority Men with HIV: A Factorial Randomized Clinical Trial. AIDS Behav. 2024 Dec;28(12):3970-3983. doi: 10.1007/s10461-024-04493-x. Epub 2024 Sep 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MI Only | Motivational interviewing focused on reducing alcohol use, delivered by videoconferencing. Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. |
| FG001 | BA Only | Brief Advice to reduce drinking delivered by videoconferencing Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking |
| FG002 | MI + ITM | Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| FG003 | BA + ITM | Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| FG004 | MI + ITM + EI | Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1 Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| FG005 | BA + ITM + EI | Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1 Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| FG006 | BA + EI | Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1 Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| FG007 | MI + EI | Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1 Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interviewing (MI) | Motivational interviewing focused on reducing alcohol use, delivered by videoconferencing. Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. |
| BG001 | Brief Advice (BA) |
| 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 | Average Number of Drinks Per Week at 6 Months | Average number of alcoholic drinks consumed per week assessed at 6 months. Covers the period of 30 days prior to the assessment. | Posted | Mean | Standard Deviation | number of drinks | Past 30 days |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MI Only | Motivational interviewing focused on reducing alcohol use, delivered by videoconferencing. Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kahler | Brown University | 401 863-6651 | christopher_kahler@brown.edu |
Not provided
| 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 2, 2024 | Apr 2, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BA + ITM + EI | Active Comparator | Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1 |
|
| BA + EI | Active Comparator | Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1 |
|
| MI + EI | Active Comparator | Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1 |
|
| Brief Advice | Behavioral | Involves 5-10 minutes of brief counseling to reduce drinking |
|
| Interactive text messaging | Behavioral | Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
|
| Providence |
| Rhode Island |
| 02912 |
| United States |
Brief Advice to reduce drinking delivered by videoconferencing Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking |
| BG002 | MI + ITM | Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| BG003 | BA + ITM | Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| BG004 | MI + ITM + EI | Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1 Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| BG005 | BA + ITM + EI | Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1 Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| BG006 | BA + EI | Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1 Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| BG007 | MI + EI | Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1 Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Alcoholic drinks per week | Mean | Standard Deviation | Alcohol drinks |
|
| Number of heavy drinking days | Days drinking 5 or more drinks in the past 30 days | Mean | Standard Deviation | days |
|
| OG002 | MI + ITM | Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| OG003 | BA + ITM | Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| OG004 | MI + ITM + EI | Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1 Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| OG005 | BA + ITM + EI | Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1 Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| OG006 | BA + EI | Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1 Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
| OG007 | MI + EI | Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1 Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. |
|
|
| Primary | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | Average number of alcoholic drinks consumed per week assessed at 12 months. Covers the period of 30 days prior to the assessment. | Posted | Mean | Standard Deviation | number of drinks | Past 30 days |
|
|
|
| Primary | Number of Heavy Drinking Days at 6 Months | Number of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 months | Posted | Mean | Standard Deviation | Days | Past 30 days |
|
|
|
| Primary | Number of Heavy Drinking Days at 12 Months | Number of days drinking 5 or more alcoholic drinks | Posted | Mean | Standard Deviation | Days | Past 30 days |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | BA Only | Brief Advice to reduce drinking delivered by videoconferencing Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | MI + ITM | Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG003 | BA + ITM | Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG004 | MI + ITM + EI | Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1 Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG005 | BA + ITM + EI | Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1 Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG006 | BA + EI | Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1 Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG007 | MI + EI | Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1 Motivational intervention: Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. Interactive text messaging: Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. | 0 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided