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

Primary Purpose

Alcohol Drinking, HIV

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motivational intervention
Brief Advice
Interactive text messaging
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Fenway Health
  • Center for Alcohol and Addiction Studies, Brown University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

MI

BA

MI + ITM

BA + ITM

MI + ITM + EI

BA + ITM + EI

BA + EI

MI + EI

Arm Description

Motivational interviewing focused on reducing alcohol use, delivered by videoconferencing.

Brief Advice to reduce drinking delivered by videoconferencing

Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use

Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use

Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1

Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1

Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1

Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2016
Last Updated
July 27, 2021
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT02709759
Brief Title
Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care
Official Title
Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MI
Arm Type
Active Comparator
Arm Description
Motivational interviewing focused on reducing alcohol use, delivered by videoconferencing.
Arm Title
BA
Arm Type
Active Comparator
Arm Description
Brief Advice to reduce drinking delivered by videoconferencing
Arm Title
MI + ITM
Arm Type
Active Comparator
Arm Description
Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use
Arm Title
BA + ITM
Arm Type
Active Comparator
Arm Description
Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use
Arm Title
MI + ITM + EI
Arm Type
Active Comparator
Arm Description
Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1
Arm Title
BA + ITM + EI
Arm Type
Active Comparator
Arm Description
Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1
Arm Title
BA + EI
Arm Type
Active Comparator
Arm Description
Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1
Arm Title
MI + EI
Arm Type
Active Comparator
Arm Description
Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1
Intervention Type
Behavioral
Intervention Name(s)
Motivational intervention
Intervention Description
Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice
Intervention Description
Involves 5-10 minutes of brief counseling to reduce drinking
Intervention Type
Behavioral
Intervention Name(s)
Interactive text messaging
Intervention Description
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 Outcome Measure Information:
Title
Number of heavy drinking days
Description
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.
Time Frame
Past 30 days
Title
Average number of drinks per week
Description
Average number of alcoholic drinks consumed per week assessed at 6 and 12 months. Covers the period of 30 days prior to the assessment.
Time Frame
Past 30 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Fenway Health
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Center for Alcohol and Addiction Studies, Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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