Hazardous DrinkingNCT01328743
Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting
A study testing Brief alcohol intervention in people with Hazardous Drinking and HIV, run by Brown University at 1 site in United States.
Trial summary
This is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hazardous Drinking, HIV
- What is being tested?
- Brief alcohol intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- drink heavily at least once per month on average (≥5 drinks) or drink more than 14 drinks per week
- have a confirmed diagnosis of HIV/AIDS
- be a male who has had sex (oral or anal) with a male partner in the past 3 months.
Who cannot join
- current intravenous drug use
- currently psychotic, suicidal, or manic
- are currently being treated or have been treated in the past 3 months for an HIV-related opportunistic infection
- currently receiving treatment for an alcohol or drug problem
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The study tests the hypothesis that brief counseling will lower drinking in these patients and that reductions in drinking will be associated with better HIV-related outcomes.
Read the detailed description
This study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (MSM), who receive their HIV primary care at Fenway Health in Boston, are randomly assigned to treatment as usual (TAU) or TAU plus a brief intervention to reduce alcohol use (TAU-BI). TAU-BI will be based in Motivational Interviewing and include personalized feedback tailored to an HIV-infected MSM population. Follow-ups will occur at 3, 6, and 12 months. The first primary aim of the study is to test the hypothesis that TAU-BI, compared to TAU, will result in reduced alcohol consumption over a 12-month follow-up period as indicated by: (1) a lower number of alcoholic drinks consumed per week; (2) a lower number of drinking days within each follow-up period; and (3) a lower number of heavy drinking days within each follow-up period. The second primary aim is to test the hypothesis that greater reductions in alcohol use will be associated with (1) greater adherence to HIV medication regimens; (2) less engagement in high-risk sexual behavior that could result in HIV transmission; (3) lower plasma HIV RNA levels (viral load) (CD4 cell counts will be a secondary outcome in this sub-aim); (4) improved liver function tests; and (5) improved neurocognitive function.
- Conditions
- Hazardous Drinking, HIV
- Being tested
- Brief alcohol intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief alcohol interventionBehavioural
3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking. |
| Brief Alcohol Intervention | Experimental | Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls Receives: Behavioral: Brief alcohol intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Alcoholic Drinks Consumed
Number of standard alcoholic drinks consumed per week in the past month
Measured: 12 months
Number of Heavy Drinking Days
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Measured: 12 months
Number of Heavy Drinking Days
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Measured: 6 months
Number of Heavy Drinking Days
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Measured: 3 months
Number of Alcoholic Drinks Consumed
Number of standard alcoholic drinks consumed per week in the past month
Measured: 3 months
Number of Alcoholic Drinks Consumed
Number of standard alcoholic drinks consumed per week in the past month
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hazardous DrinkingStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Monti, Brown University
- Investigators
- Peter Monti, Ph.D., Principal investigator, Brown UniversityChristopher Kahler, Ph.D., Study director, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328743
- Sponsor's protocol ID
- NIAAA-P01-AA019072-1
- Status last verified
- Aug 2019
- First submitted
- 31 Mar 2011
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zelaya DG, Guy AA, Surace A, Mastroleo NR, Pantalone DW, Monti PM, Mayer KH, Kahler CW. Modeling the Impact of Race, Socioeconomic Status, Discrimination and Cognitive Appraisal on Mental Health Concerns Among Heavy Drinking HIV+ Cisgender MSM. AIDS Behav. 2022 Dec;26(12):3925-3938. doi: 10.1007/s10461-022-03719-0. Epub 2022 Jun 10.
PubMed 35687187
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT01328743
- Acronym / sponsor ID
- NIAAA-P01-AA019072-1
- Conditions
- Hazardous Drinking, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The study tests the hypothesis that brief counseling will lower drinking in these patients and that reductions in drinking will be associated with better HIV-related outcomes.
Detailed description
This study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (MSM), who receive their HIV primary care at Fenway Health in Boston, are randomly assigned to treatment as usual (TAU) or TAU plus a brief intervention to reduce alcohol use (TAU-BI). TAU-BI will be based in Motivational Interviewing and include personalized feedback tailored to an HIV-infected MSM population. Follow-ups will occur at 3, 6, and 12 months. The first primary aim of the study is to test the hypothesis that TAU-BI, compared to TAU, will result in reduced alcohol consumption over a 12-month follow-up period as indicated by: (1) a lower number of alcoholic drinks consumed per week; (2) a lower number of drinking days within each follow-up period; and (3) a lower number of heavy drinking days within each follow-up period. The second primary aim is to test the hypothesis that greater reductions in alcohol use will be associated with (1) greater adherence to HIV medication regimens; (2) less engagement in high-risk sexual behavior that could result in HIV transmission; (3) lower plasma HIV RNA levels (viral load) (CD4 cell counts will be a secondary outcome in this sub-aim); (4) improved liver function tests; and (5) improved neurocognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking. |
| Brief Alcohol Intervention | Experimental | Behavioral: Brief alcohol interventionParticipants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be at least 18 years of age
- drink heavily at least once per month on average (≥5 drinks) or drink more than 14 drinks per week
- have a confirmed diagnosis of HIV/AIDS
- be a male who has had sex (oral or anal) with a male partner in the past 3 months.
Key exclusion criteria (4 listed)
- current intravenous drug use
- currently psychotic, suicidal, or manic
- are currently being treated or have been treated in the past 3 months for an HIV-related opportunistic infection
- currently receiving treatment for an alcohol or drug problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief alcohol intervention3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking | Behavioural | Brief Alcohol Intervention |
Primary outcome
Number of Alcoholic Drinks Consumed
Time frame: 12 months
Number of standard alcoholic drinks consumed per week in the past month
Number of Heavy Drinking Days
Time frame: 12 months
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Number of Heavy Drinking Days
Time frame: 6 months
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Number of Heavy Drinking Days
Time frame: 3 months
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Number of Alcoholic Drinks Consumed
Time frame: 3 months
Number of standard alcoholic drinks consumed per week in the past month
Number of Alcoholic Drinks Consumed
Time frame: 6 months
Number of standard alcoholic drinks consumed per week in the past month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35687187Zelaya DG, Guy AA, Surace A, Mastroleo NR, Pantalone DW, Monti PM, Mayer KH, Kahler CW. Modeling the Impact of Race, Socioeconomic Status, Discrimination and Cognitive Appraisal on Mental Health Concerns Among Heavy Drinking HIV+ Cisgender MSM. AIDS Behav. 2022 Dec;26(12):3925-3938. doi: 10.1007/s10461-022-03719-0. Epub 2022 Jun 10.
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Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations
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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.
Peter Monti, Ph.D. principal investigator
Brown University
Christopher Kahler, Ph.D. study director
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief alcohol intervention in people with Hazardous Drinking and HIV, run by Brown University at 1 site in United States.
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 4 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 9 Sep 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Alcoholic Drinks Consumed (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01328743, which also lists 1 linked publication.
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 9 Sep 2019.