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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Drinking; HIV
• Intervention / Treatment: Behavioral: Motivational intervention; Behavioral: Brief Advice; Behavioral: Interactive text messaging

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.

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States
      • Fenway Health
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Center for Alcohol and Addiction Studies, Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: MI; Motivational interviewing focused on reducing alcohol use, delivered by videoconferencing.	Behavioral: Motivational intervention; Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.
ACTIVE_COMPARATOR: BA; Brief Advice to reduce drinking delivered by videoconferencing	Behavioral: Brief Advice; Involves 5-10 minutes of brief counseling to reduce drinking
ACTIVE_COMPARATOR: MI + ITM; Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use	Behavioral: Motivational intervention; Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.; Behavioral: 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.
ACTIVE_COMPARATOR: BA + ITM; Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use	Behavioral: Brief Advice; Involves 5-10 minutes of brief counseling to reduce drinking; Behavioral: 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.
ACTIVE_COMPARATOR: MI + ITM + EI; Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1	Behavioral: Motivational intervention; Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.; Behavioral: 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.
ACTIVE_COMPARATOR: BA + ITM + EI; Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1	Behavioral: Brief Advice; Involves 5-10 minutes of brief counseling to reduce drinking; Behavioral: 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.
ACTIVE_COMPARATOR: BA + EI; Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1	Behavioral: Brief Advice; Involves 5-10 minutes of brief counseling to reduce drinking; Behavioral: 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.
ACTIVE_COMPARATOR: MI + EI; Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1	Behavioral: Motivational intervention; Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of heavy drinking days	Number of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 and 12 months. Covers the period of 30 days prior to the assessment.	Past 30 days
Average number of drinks per week	Average number of alcoholic drinks consumed per week assessed at 6 and 12 months. Covers the period of 30 days prior to the assessment.	Past 30 days

Collaborators and Investigators

• Sponsor: Brown University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): May 1, 2021
• Study Completion (ANTICIPATED): August 30, 2021

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (ESTIMATE): March 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: P01AA01907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO