Clinical trial NCT02709759: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
HIV
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 210
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average Number of Drinks Per Week at 6 Months
timeFrame: Past 30 days
measure: Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months
timeFrame: Past 30 days
measure: Number of Heavy Drinking Days at 6 Months
timeFrame: Past 30 days
measure: Number of Heavy Drinking Days at 12 Months
timeFrame: Past 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies, Brown University
state: Rhode Island
Study officials:
References: