Alcohol Drinking, HIV
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.
Involves 5-10 minutes of brief counseling to reduce drinking
Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals.
Sponsors
Study design
Eligibility
Inclusion criteria
* be at least 18 years of age * drink heavily at least once per month on average (≥5 drinks) or drink have drunk more than 14 drinks per week over the past 3 months * have a confirmed diagnosis of HIV * be a biological male who identifies as male * report having had sex (oral or anal) with a male partner in the past 12 months and/or, identify as gay or bisexual. * For those on ART, they must be stabilized on their current regimen for at least 3 months prior to study enrollment.
Exclusion criteria
* report past 3 month intravenous drug use * are currently psychotic, suicidal, or manic * being treated or have been treated in the past 3 months for an HIV-related opportunistic infection * currently receiving treatment for an alcohol or drug problem.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Drinks Per Week at 6 Months | Past 30 days | Average number of alcoholic drinks consumed per week assessed at 6 months. Covers the period of 30 days prior to the assessment. |
| Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | Past 30 days | Average number of alcoholic drinks consumed per week assessed at 12 months. Covers the period of 30 days prior to the assessment. |
| Number of Heavy Drinking Days at 6 Months | Past 30 days | Number of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 months |
| Number of Heavy Drinking Days at 12 Months | Past 30 days | Number of days drinking 5 or more alcoholic drinks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Brief Advice (BA) Brief Advice to reduce drinking delivered by videoconferencing
Brief Advice: Involves 5-10 minutes of brief counseling to reduce drinking | 24 |
| 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. | 23 |
| 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. | 23 |
| 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. | 23 |
| 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. | 23 |
| 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. | 24 |
| 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. | 24 |
| Total | 188 |
Baseline characteristics
| Characteristic | Motivational Interviewing (MI) | Brief Advice (BA) | MI + ITM | BA + ITM | MI + ITM + EI | BA + ITM + EI | BA + EI | MI + EI | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 9.4 | 47.8 years STANDARD_DEVIATION 8.1 | 46.7 years STANDARD_DEVIATION 11.9 | 48.0 years STANDARD_DEVIATION 13.4 | 51.2 years STANDARD_DEVIATION 9.3 | 21.7 years STANDARD_DEVIATION 9.8 | 49.3 years STANDARD_DEVIATION 12.2 | 51.0 years STANDARD_DEVIATION 9.5 | 49.3 years STANDARD_DEVIATION 10.6 |
| Alcoholic drinks per week | 27.1 Alcohol drinks STANDARD_DEVIATION 19.2 | 23.4 Alcohol drinks STANDARD_DEVIATION 18.2 | 24.3 Alcohol drinks STANDARD_DEVIATION 16.9 | 19.1 Alcohol drinks STANDARD_DEVIATION 19.8 | 20.7 Alcohol drinks STANDARD_DEVIATION 14.7 | 28.6 Alcohol drinks STANDARD_DEVIATION 26.2 | 26.3 Alcohol drinks STANDARD_DEVIATION 21.4 | 35.7 Alcohol drinks STANDARD_DEVIATION 35.8 | 25.7 Alcohol drinks STANDARD_DEVIATION 22.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 4 Participants | 9 Participants | 4 Participants | 6 Participants | 4 Participants | 8 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants | 19 Participants | 14 Participants | 19 Participants | 17 Participants | 20 Participants | 16 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of heavy drinking days | 11.8 days STANDARD_DEVIATION 10.2 | 8.4 days STANDARD_DEVIATION 8.9 | 10.5 days STANDARD_DEVIATION 10 | 7.4 days STANDARD_DEVIATION 8.7 | 8.8 days STANDARD_DEVIATION 7.5 | 10.5 days STANDARD_DEVIATION 10.1 | 12.0 days STANDARD_DEVIATION 11.8 | 10.7 days STANDARD_DEVIATION 10.1 | 10.0 days STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 13 Participants | 15 Participants | 12 Participants | 14 Participants | 18 Participants | 12 Participants | 12 Participants | 112 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 9 Participants | 6 Participants | 9 Participants | 7 Participants | 5 Participants | 10 Participants | 11 Participants | 64 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 23 Participants | 23 Participants | 23 Participants | 23 Participants | 24 Participants | 24 Participants | 188 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | 8.3 number of drinks | Standard Deviation 7.2 |
| Brief Advice (BA) | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | 16.5 number of drinks | Standard Deviation 17 |
| MI + ITM | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | 4.6 number of drinks | Standard Deviation 5.9 |
| BA + ITM | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | 3.7 number of drinks | Standard Deviation 5.3 |
| MI + ITM + EI | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | 5.4 number of drinks | Standard Deviation 7.1 |
| BA + ITM + EI | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | 8.1 number of drinks | Standard Deviation 9.9 |
| BA + EI | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | 7.0 number of drinks | Standard Deviation 8.9 |
| MI + EI | Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months | 11.6 number of drinks | Standard Deviation 13.4 |
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.
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) | Average Number of Drinks Per Week at 6 Months | 13.3 number of drinks | Standard Deviation 14.7 |
| Brief Advice (BA) | Average Number of Drinks Per Week at 6 Months | 14.9 number of drinks | Standard Deviation 17.4 |
| MI + ITM | Average Number of Drinks Per Week at 6 Months | 7.5 number of drinks | Standard Deviation 8.7 |
| BA + ITM | Average Number of Drinks Per Week at 6 Months | 5.0 number of drinks | Standard Deviation 5.9 |
| MI + ITM + EI | Average Number of Drinks Per Week at 6 Months | 9.6 number of drinks | Standard Deviation 10.2 |
| BA + ITM + EI | Average Number of Drinks Per Week at 6 Months | 7.6 number of drinks | Standard Deviation 12.2 |
| BA + EI | Average Number of Drinks Per Week at 6 Months | 7.7 number of drinks | Standard Deviation 9.3 |
| MI + EI | Average Number of Drinks Per Week at 6 Months | 17.8 number of drinks | Standard Deviation 22.5 |
Number of Heavy Drinking Days at 12 Months
Number of days drinking 5 or more alcoholic drinks
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) | Number of Heavy Drinking Days at 12 Months | 2.2 Days | Standard Deviation 2.7 |
| Brief Advice (BA) | Number of Heavy Drinking Days at 12 Months | 5.6 Days | Standard Deviation 9.6 |
| MI + ITM | Number of Heavy Drinking Days at 12 Months | 1.8 Days | Standard Deviation 3.4 |
| BA + ITM | Number of Heavy Drinking Days at 12 Months | 1.2 Days | Standard Deviation 3 |
| MI + ITM + EI | Number of Heavy Drinking Days at 12 Months | 2.6 Days | Standard Deviation 4.9 |
| BA + ITM + EI | Number of Heavy Drinking Days at 12 Months | 2.7 Days | Standard Deviation 4 |
| BA + EI | Number of Heavy Drinking Days at 12 Months | 2.4 Days | Standard Deviation 4.5 |
| MI + EI | Number of Heavy Drinking Days at 12 Months | 3.8 Days | Standard Deviation 6.7 |
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
Time frame: Past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) | Number of Heavy Drinking Days at 6 Months | 4.3 Days | Standard Deviation 5.8 |
| Brief Advice (BA) | Number of Heavy Drinking Days at 6 Months | 5.2 Days | Standard Deviation 8.1 |
| MI + ITM | Number of Heavy Drinking Days at 6 Months | 1.8 Days | Standard Deviation 2.7 |
| BA + ITM | Number of Heavy Drinking Days at 6 Months | 1.4 Days | Standard Deviation 2.3 |
| MI + ITM + EI | Number of Heavy Drinking Days at 6 Months | 3.1 Days | Standard Deviation 5 |
| BA + ITM + EI | Number of Heavy Drinking Days at 6 Months | 3.5 Days | Standard Deviation 7.7 |
| BA + EI | Number of Heavy Drinking Days at 6 Months | 1.6 Days | Standard Deviation 3.4 |
| MI + EI | Number of Heavy Drinking Days at 6 Months | 6.1 Days | Standard Deviation 9.9 |