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



Status:Recruiting
Conditions:HIV / AIDS, Psychiatric
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:1/20/2018
Start Date:August 2016
End Date:December 2020
Contact:Christopher Kahler, PhD
Email:Christopher_Kahler@brown.edu
Phone:401 863-6651

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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.

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.

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.
We found this trial at
2
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mi
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Providence, RI
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Boston, Massachusetts 02215
Phone: 857-313-6689
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mi
from
Boston, MA
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