Alcohol DrinkingF-REDARTNCT02153216
Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load
An observational study of Alcohol Drinking and Alcohol Use Norms, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.
Trial summary
This study is the Formative Phase of a larger study; once this phase is completed, enrollment into the randomized controlled trial (RCT Phase) will begin. The primary objective of the Formative Phase is to gain a better understanding of the context in which drinking alcohol among ART client in Vietnam occurs, in order… Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Alcohol Drinking, Alcohol Use Norms, Alcohol Use Among ART Clients
- How many people
- 40 participants
- Where
- 1 siteVietnam
- Study dates
- May 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: ART clients with hazardous alcohol use; PWID in general population with hazardous alcohol use
Who may be able to join
- being 18-49 years of age;
- having an AUDIT score ≥ 8 (hazardous alcohol use);
- being a current ART client at one of the Thai Nguyen ART clinics or a general population PWID;
- being capable of providing voluntary informed consent.
Who cannot join
- being unable to participate in study activities due to psychological disturbance, cognitive impairment or threatening behavior;
- currently participating in other HIV, drug use or alcohol studies.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Thai Nguyen Center for Preventive Medicine
Thai Nguyen, Thai Nguyen
About this study
Official title: Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load: An RCT in ART Clinics in Vietnam
This study is the Formative Phase of a larger study; once this phase is completed, enrollment into the randomized controlled trial (RCT Phase) will begin. The primary objective of the Formative Phase is to gain a better understanding of the context in which drinking alcohol among ART client in Vietnam occurs, in order to culturally tailor the intervention to be tested in the RCT Phase. Formative Phase activities will consist of up to 40 in-depth interviews with hazardous drinkers who are either: a) ART clients in one of the ART clinics in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not recruited from the ART clinics (whom we will refer to as general population PWID).
- Medical subject headings
- Alcohol Drinking
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of heavy drinking episodes
This will be an assessment of how and why individuals engage in heavy drinking. As part of this exploration, we will assess:
- number of standard drinks consumed on those days that an individual drank
- number of days on which alcohol was consumed beyond recommended levels
Measured: during interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Vivian F Go, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153216
- Sponsor's protocol ID
- 14-0225a
- Other IDs
- 1R01DA037440-01
- Acronym
- F-REDART
- Status last verified
- May 2016
- First submitted
- 29 May 2014
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load: An RCT in ART Clinics in Vietnam
- ClinicalTrials.gov ID
- NCT02153216
- Acronym / sponsor ID
- F-REDART / 14-0225a
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is the Formative Phase of a larger study; once this phase is completed, enrollment into the randomized controlled trial (RCT Phase) will begin. The primary objective of the Formative Phase is to gain a better understanding of the context in which drinking alcohol among ART client in Vietnam occurs, in order to culturally tailor the intervention to be tested in the RCT Phase. Formative Phase activities will consist of up to 40 in-depth interviews with hazardous drinkers who are either: a) ART clients in one of the ART clinics in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not recruited from the ART clinics (whom we will refer to as general population PWID).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ART clients with hazardous alcohol use; PWID in general population with hazardous alcohol use
Key inclusion criteria (4 listed)
- being 18-49 years of age;
- having an AUDIT score ≥ 8 (hazardous alcohol use);
- being a current ART client at one of the Thai Nguyen ART clinics or a general population PWID;
- being capable of providing voluntary informed consent.
Key exclusion criteria (2 listed)
- being unable to participate in study activities due to psychological disturbance, cognitive impairment or threatening behavior;
- currently participating in other HIV, drug use or alcohol studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of heavy drinking episodes
Time frame: during interviews
This will be an assessment of how and why individuals engage in heavy drinking. As part of this exploration, we will assess: * number of standard drinks consumed on those days that an individual drank * number of days on which alcohol was consumed beyond recommended levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian F Go, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Drinking and Alcohol Use Norms, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of heavy drinking episodes (time frame: during interviews). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.