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NCT03652675 · ClinicalTrials.gov registry record · NA

Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV

A NA study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
NA
Development phase
31
Enrollment target

NCT03652675 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 31 participants.

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The verdict

NCT03652675, a NA study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
NA
Development phase
31 participants
Enrollment target

Study Summary

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.

Interventions

  • BEHAVIORAL Intervention: (Clinician's Guide + HealthCall for HIV/HCV)

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2018-11-01
Est. Completion 2020-06-08
Phase NA

What the Registry Record Tells You About NCT03652675

The ClinicalTrials.gov registry entry for NCT03652675 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Intervention: (Clinician's Guide + HealthCall for HIV/HCV) is the first listed.

NCT03652675 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03652675 about?

NCT03652675 is a clinical study titled "Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV". 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....

What is the current status of trial NCT03652675?

This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2018-11-01. Estimated completion is 2020-06-08.

What interventions are being tested in trial NCT03652675?

The interventions under investigation include: Intervention: (Clinician's Guide + HealthCall for HIV/HCV) (BEHAVIORAL).

Who is sponsoring clinical trial NCT03652675?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.