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NCT04280068 · ClinicalTrials.gov registry record · NA

Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care

A NA study, sponsored by Research Foundation for Mental Hygiene.

Terminated
Registry status
NA
Development phase
3
Enrollment target

NCT04280068: Clinical Trial NA study, sponsored by Research Foundation for Mental Hygiene.

NCT04280068 is a NA study that was terminated before completion, run by Research Foundation for Mental Hygiene. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04280068, a NA study, was terminated before completion, sponsored by Research Foundation for Mental Hygiene.

TERMINATED
Registry status
NA
Development phase
3 participants
Enrollment target

Study Summary

The proposed pilot study is a randomized feasibility trial of technology-enhanced brief intervention for drinking reduction and antiretroviral therapy (ART) adherence in 60 non-virally suppressed HIV participants who meet criteria for DSM-5 Alcohol Use Disorder (AUD) in a Primary Care clinic. Study sample will be recruited from a large urban HIV primary care clinic at Montefiore Hospital where the investigators previously successfully enrolled, randomized and treated study participants The interventions consist of brief meetings to discuss drinking and ART adherence enhanced with daily self-monitoring through the use of a smartphone application that tracks drinking and other aspects of health. These meetings will be based on the Clinician's Guide, a brief intervention for heavy drinking in primary care settings advocated by the National Institute on Alcohol Abuse and Alcoholism. Participants will be assessed at baseline, 30, 60, 90 days, and 6 months after baseline. By the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the Clinician's Guide alone, and lowest among participants who receive the Clinician's Guide plus the smartphone application.

Primary Outcome

Assessing change over time in the total number of drinks in the past 30 days from baseline to each time point.

Interventions

  • BEHAVIORAL Clinician Guide (CG)
  • BEHAVIORAL Clinician Guide plus HealthCall

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2020-03-02
Est. Completion 2020-06-30
Phase NA

Why NCT04280068 stopped before completion

NCT04280068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Clinician Guide (CG) is the first listed.

NCT04280068 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04280068 about?

NCT04280068 is a clinical study titled "Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care". The proposed pilot study is a randomized feasibility trial of technology-enhanced brief intervention for drinking reduction and antiretroviral therapy (ART) adherence in 60 non-virally suppressed HIV participants who meet criteria for DSM-5 Alcohol Use Disorder (AUD) in a Primary Care clinic. Study...

What is the current status of trial NCT04280068?

This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2020-03-02. Estimated completion is 2020-06-30.

What interventions are being tested in trial NCT04280068?

The interventions under investigation include: Clinician Guide (CG) (BEHAVIORAL), Clinician Guide plus HealthCall (BEHAVIORAL).

Who is sponsoring clinical trial NCT04280068?

This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04280068's enrollment target sits among peer trials

3 1996th of 2000 higher than 4 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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Source: ClinicalTrials.gov NCT04280068, the US trial registry maintained by the National Library of Medicine. NCT04280068 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.