Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
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|ClinicalTrials.gov Identifier: NCT03652675|
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : July 12, 2019
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. Potential participants from outside of this clinic will also be recruited through self-referrals via flyers and through RecruitMe, an online based recruitment tool. 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.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder HIV/AIDS Hepatitis C Binge Drinking||Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||After participants complete the screening assessment, the research coordinator will be able to determine alcohol use disorder status from the responses. The research coordinator will provide the counselor or PI with subject identification number (ID; assigned consecutively) and alcohol use disorder status. The counselor or PI will then randomize participants using pre-determined blocked lists created by a biostatistician, in order to balance treatment groups across alcohol use disorder status (the research coordinator will not randomize in order to remain blind to condition).|
|Official Title:||Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV: Clinical Trial|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|Experimental: Intervention: (Clinician's Guide + HealthCall for HIV/HCV)||
Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
This intervention consists of an adaptation of the National Institutes of Health (NIH) Clinician's Guide (CG; NIAAA, 2007) in conjunction with the previously tested HealthCall smartphone app program (Hasin et al., 2013; Hasin et al., 2014). Participants will complete a brief baseline meeting (~20 minutes) with a counselor to discuss alcohol use, liver function, and HIV medication adherence. They will track their drinking using HealthCall for 60 days, with brief follow-up meetings with their counselor to check in about their drinking 30 and 60 days later.
No Intervention: Educational control condition
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
- Change in mean drinks per drinking day measured using Timeline Follow Back (TLFB) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]Mean drinks per drinking day in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
- Change in measures of alcohol use assessed by items from the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]Other measures of alcohol use (drinking frequency, maximum quantity of drinks per day, frequency of binge drinking and intoxication) for the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
- Change in readiness to change drinking measured by University of Rhode Island Change Assessment Scale (URICA) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]Readiness to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
- Change in readiness to change drinking measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]Readiness to change drinking in the last 30 days,assessed at baseline and repeatedly during follow-up so that change can be analyzed.
- Change in self-efficacy to change drinking measured by brief version of Situational Confidence Questionnaire (SCQ) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]Change in self-efficacy to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652675
|Contact: Jennifer C Elliott, Ph.Demail@example.com|
|United States, New York|
|NewYork-Presbyterian / Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator:||Jennifer C Elliott, Ph.D||New York State Psychiatric Institute|