Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 11/21/2018 |
| Start Date: | November 1, 2018 |
| End Date: | December 2019 |
| Contact: | Jennifer C Elliott, Ph.D |
| Email: | jennifer.elliott@nyspi.columbia.edu |
| Phone: | 646-774-7953 |
Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV: Clinical Trial
Among patients with HIV, especially those also infected with HCV, heavy drinking is
associated with significant risks to health. However, little is known about how to best
intervene with co-infected heavy drinkers, a particularly high risk group for whom targeted
intervention has not been developed. Therefore, this study proposes to test a newly developed
drinking-reduction intervention for patients with both HIV and HCV, which combines components
of successful interventions developed for HIV and for liver disease patients.
60 HIV/HCV co-infected drinkers from HIV primary care will be recruited in order to ensure an
adequate final sample size of 45 participants completing the study. A clinic recruiter will
identify and refer potential participants based on their medical record, who will then be
screened for eligibility by the research coordinator. Participants will be randomly assigned
to an intervention or control condition, while ensuring that equal numbers of individuals
with alcohol use disorder are assigned to each condition. The intervention condition will
receive brief in-person sessions with a counselor and will be asked to use a smartphone app
daily to keep track of drinking and other health behaviors for two months. The intervention
sessions will include information about HIV, HCV and alcohol, and the counselor will give the
participant information about their liver function and alcohol use to try to motivate them to
drink less. The control condition will simply be asked to drink less and will be given
pamphlets with general information on HIV, Hepatitis C, and drinking from educational
websites on HIV/HCV co-infection. The intervention condition will then be evaluated to see if
it was more effective at reducing drinking than the control condition.
associated with significant risks to health. However, little is known about how to best
intervene with co-infected heavy drinkers, a particularly high risk group for whom targeted
intervention has not been developed. Therefore, this study proposes to test a newly developed
drinking-reduction intervention for patients with both HIV and HCV, which combines components
of successful interventions developed for HIV and for liver disease patients.
60 HIV/HCV co-infected drinkers from HIV primary care will be recruited in order to ensure an
adequate final sample size of 45 participants completing the study. A clinic recruiter will
identify and refer potential participants based on their medical record, who will then be
screened for eligibility by the research coordinator. Participants will be randomly assigned
to an intervention or control condition, while ensuring that equal numbers of individuals
with alcohol use disorder are assigned to each condition. The intervention condition will
receive brief in-person sessions with a counselor and will be asked to use a smartphone app
daily to keep track of drinking and other health behaviors for two months. The intervention
sessions will include information about HIV, HCV and alcohol, and the counselor will give the
participant information about their liver function and alcohol use to try to motivate them to
drink less. The control condition will simply be asked to drink less and will be given
pamphlets with general information on HIV, Hepatitis C, and drinking from educational
websites on HIV/HCV co-infection. The intervention condition will then be evaluated to see if
it was more effective at reducing drinking than the control condition.
Patients with HIV have high rates of heavy drinking and alcohol problems, and face serious
medical consequences from this use. Some research suggests that alcohol can increase viral
load and decrease CD4 (cluster of differentiation 4; e.g., T helper cells) count, although
this literature is conflicting. It also increases risk for liver damage, as does hepatitis
co-infection, making liver disease a leading cause of death for patients with HIV. Patients
with alcohol problems are also less adherent to antiretroviral therapy (ART), and some
intentionally skip ART to try to avoid hepatotoxic effects of combining ART with alcohol.
Some studies also show alcohol's interference with other aspects of engagement in HIV care.
Approximately 25% of HIV-infected patients are co-infected with HCV. Although HCV alone can
lead to liver damage, HIV accelerates this progression, as does heavy drinking. Further,
individuals with HCV who drink heavily may be less likely to access HCV medication. Despite
serious health risks associated with alcohol use, some research suggests that HIV/HCV
patients drink more than HIV mono-infected patients.
Growing recognition of alcohol-related harm in HIV patients has stimulated the development of
drinking reduction interventions for HIV infected heavy drinkers, some of which have been
successful. Some interventions for HCV mono-infected drinkers and liver disease patients have
also shown promise. Yet there are no known successful interventions that target HIV/HCV
co-infected patients, a group with elevated drinking and particularly high consequences of
drinking. Interventions for HIV patients address HIV health, but do not address liver
fibrosis, which is an urgent threat to survival for co-infected patients. Interventions for
liver disease patients discuss fibrosis to motivate drinking reduction, but neglect HIV and
important topics such as ART adherence. Given that the drinking interventions for HIV and
liver disease patients both effectively target drinking in medical patients, albeit through
attention to different medical issues, such approaches can and should be integrated to
provide an intervention that best meets the needs of patients with both HIV and HCV, a
particularly high-risk group. In order to meet this need, an intervention will be tested for
HIV/HCV co-infected drinkers. A total of 60 patients will be recruited and randomized to
receive either the newly developed intervention or an educational control.
medical consequences from this use. Some research suggests that alcohol can increase viral
load and decrease CD4 (cluster of differentiation 4; e.g., T helper cells) count, although
this literature is conflicting. It also increases risk for liver damage, as does hepatitis
co-infection, making liver disease a leading cause of death for patients with HIV. Patients
with alcohol problems are also less adherent to antiretroviral therapy (ART), and some
intentionally skip ART to try to avoid hepatotoxic effects of combining ART with alcohol.
Some studies also show alcohol's interference with other aspects of engagement in HIV care.
Approximately 25% of HIV-infected patients are co-infected with HCV. Although HCV alone can
lead to liver damage, HIV accelerates this progression, as does heavy drinking. Further,
individuals with HCV who drink heavily may be less likely to access HCV medication. Despite
serious health risks associated with alcohol use, some research suggests that HIV/HCV
patients drink more than HIV mono-infected patients.
Growing recognition of alcohol-related harm in HIV patients has stimulated the development of
drinking reduction interventions for HIV infected heavy drinkers, some of which have been
successful. Some interventions for HCV mono-infected drinkers and liver disease patients have
also shown promise. Yet there are no known successful interventions that target HIV/HCV
co-infected patients, a group with elevated drinking and particularly high consequences of
drinking. Interventions for HIV patients address HIV health, but do not address liver
fibrosis, which is an urgent threat to survival for co-infected patients. Interventions for
liver disease patients discuss fibrosis to motivate drinking reduction, but neglect HIV and
important topics such as ART adherence. Given that the drinking interventions for HIV and
liver disease patients both effectively target drinking in medical patients, albeit through
attention to different medical issues, such approaches can and should be integrated to
provide an intervention that best meets the needs of patients with both HIV and HCV, a
particularly high-risk group. In order to meet this need, an intervention will be tested for
HIV/HCV co-infected drinkers. A total of 60 patients will be recruited and randomized to
receive either the newly developed intervention or an educational control.
Inclusion Criteria:
- Age 18 through 99 (inclusive)
- HIV infection
- Ever been diagnosed with HCV infection (regardless of treatment status; including
active or remitted infection)
- Recent (last 3 month) liver panel results available
- During prior 30 days, ≥4 drinks in one day at least once*
- Can speak and read English
Exclusion Criteria:
- Participation in ongoing HealthCall study at Montefiore Hospital
- Potential participant has definite plans to leave the greater New York metropolitan
area during study period
- Potential participant is psychotic, suicidal, or homicidal
We found this trial at
1
site
273 Bleecker Street
New York, New York 10014
New York, New York 10014
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