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Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care

Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02709759
Enrollment
210
Registered
2016-03-16
Start date
2016-08-31
Completion date
2022-01-20
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, HIV

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.

BEHAVIORALBrief Advice

Involves 5-10 minutes of brief counseling to reduce drinking

BEHAVIORALInteractive 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.

Sponsors

Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Average Number of Drinks Per Week at 6 MonthsPast 30 daysAverage 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 MonthsPast 30 daysAverage 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 MonthsPast 30 daysNumber of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 months
Number of Heavy Drinking Days at 12 MonthsPast 30 daysNumber of days drinking 5 or more alcoholic drinks

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total188

Baseline characteristics

CharacteristicMotivational Interviewing (MI)Brief Advice (BA)MI + ITMBA + ITMMI + ITM + EIBA + ITM + EIBA + EIMI + EITotal
Age, Continuous48.4 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 week27.1 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 Participants6 Participants4 Participants9 Participants4 Participants6 Participants4 Participants8 Participants47 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants18 Participants19 Participants14 Participants19 Participants17 Participants20 Participants16 Participants141 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Number of heavy drinking days11.8 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 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
16 Participants13 Participants15 Participants12 Participants14 Participants18 Participants12 Participants12 Participants112 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants1 Participants2 Participants1 Participants0 Participants1 Participants0 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
White
7 Participants9 Participants6 Participants9 Participants7 Participants5 Participants10 Participants11 Participants64 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
24 Participants24 Participants23 Participants23 Participants23 Participants23 Participants24 Participants24 Participants188 Participants

Adverse events

Event typeEG000
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 / 240 / 240 / 230 / 230 / 230 / 230 / 240 / 24
other
Total, other adverse events
0 / 240 / 240 / 230 / 230 / 230 / 230 / 240 / 24
serious
Total, serious adverse events
0 / 240 / 240 / 230 / 230 / 230 / 230 / 240 / 24

Outcome results

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.

Time frame: Past 30 days

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI)Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months8.3 number of drinksStandard Deviation 7.2
Brief Advice (BA)Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months16.5 number of drinksStandard Deviation 17
MI + ITMAverage Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months4.6 number of drinksStandard Deviation 5.9
BA + ITMAverage Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months3.7 number of drinksStandard Deviation 5.3
MI + ITM + EIAverage Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months5.4 number of drinksStandard Deviation 7.1
BA + ITM + EIAverage Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months8.1 number of drinksStandard Deviation 9.9
BA + EIAverage Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months7.0 number of drinksStandard Deviation 8.9
MI + EIAverage Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months11.6 number of drinksStandard Deviation 13.4
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.

Time frame: Past 30 days

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI)Average Number of Drinks Per Week at 6 Months13.3 number of drinksStandard Deviation 14.7
Brief Advice (BA)Average Number of Drinks Per Week at 6 Months14.9 number of drinksStandard Deviation 17.4
MI + ITMAverage Number of Drinks Per Week at 6 Months7.5 number of drinksStandard Deviation 8.7
BA + ITMAverage Number of Drinks Per Week at 6 Months5.0 number of drinksStandard Deviation 5.9
MI + ITM + EIAverage Number of Drinks Per Week at 6 Months9.6 number of drinksStandard Deviation 10.2
BA + ITM + EIAverage Number of Drinks Per Week at 6 Months7.6 number of drinksStandard Deviation 12.2
BA + EIAverage Number of Drinks Per Week at 6 Months7.7 number of drinksStandard Deviation 9.3
MI + EIAverage Number of Drinks Per Week at 6 Months17.8 number of drinksStandard Deviation 22.5
Primary

Number of Heavy Drinking Days at 12 Months

Number of days drinking 5 or more alcoholic drinks

Time frame: Past 30 days

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI)Number of Heavy Drinking Days at 12 Months2.2 DaysStandard Deviation 2.7
Brief Advice (BA)Number of Heavy Drinking Days at 12 Months5.6 DaysStandard Deviation 9.6
MI + ITMNumber of Heavy Drinking Days at 12 Months1.8 DaysStandard Deviation 3.4
BA + ITMNumber of Heavy Drinking Days at 12 Months1.2 DaysStandard Deviation 3
MI + ITM + EINumber of Heavy Drinking Days at 12 Months2.6 DaysStandard Deviation 4.9
BA + ITM + EINumber of Heavy Drinking Days at 12 Months2.7 DaysStandard Deviation 4
BA + EINumber of Heavy Drinking Days at 12 Months2.4 DaysStandard Deviation 4.5
MI + EINumber of Heavy Drinking Days at 12 Months3.8 DaysStandard Deviation 6.7
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

Time frame: Past 30 days

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI)Number of Heavy Drinking Days at 6 Months4.3 DaysStandard Deviation 5.8
Brief Advice (BA)Number of Heavy Drinking Days at 6 Months5.2 DaysStandard Deviation 8.1
MI + ITMNumber of Heavy Drinking Days at 6 Months1.8 DaysStandard Deviation 2.7
BA + ITMNumber of Heavy Drinking Days at 6 Months1.4 DaysStandard Deviation 2.3
MI + ITM + EINumber of Heavy Drinking Days at 6 Months3.1 DaysStandard Deviation 5
BA + ITM + EINumber of Heavy Drinking Days at 6 Months3.5 DaysStandard Deviation 7.7
BA + EINumber of Heavy Drinking Days at 6 Months1.6 DaysStandard Deviation 3.4
MI + EINumber of Heavy Drinking Days at 6 Months6.1 DaysStandard Deviation 9.9

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026