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NCT04280068
Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
NA trial testing Clinician Guide (CG) in Alcohol Dependence in 3 participants. Terminated before completion.
27 March 2020
Quick facts
| Lead sponsor | Research Foundation for Mental Hygiene, Inc. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 2 March 2020 |
| Primary completion | 27 March 2020 |
| Estimated completion | 30 June 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Clinician Guide (CG)
- Clinician Guide plus HealthCall
Conditions studied
- Alcohol Dependence — all drugs for Alcohol Dependence →
- HIV/AIDS — all drugs for HIV/AIDS →
Sponsor
Research Foundation for Mental Hygiene, Inc.
Who can join
18 and older, any sex, with Alcohol Dependence or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04280068
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04280068 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Research Foundation for Mental Hygiene, Inc.
- Last refreshed: 9 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04280068.
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