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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: Completed NA study, sponsored by New York State Psychiatric Institute.
NCT03652675 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean drinks per drinking day in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Abstention is coded as zero.
Interventions
- BEHAVIORAL Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2020-06-08 |
| Phase | NA |
What the finished NCT03652675 record still lists
NCT03652675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03652675's enrollment target sits among peer trials
31 1592nd of 2000 higher than 408 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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