Alcohol DrinkingNCT02709759
Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care
A study testing Motivational intervention, Brief Advice and Interactive text messaging in people with Alcohol Drinking and HIV, run by Brown University at 2 sites in United States.
Trial summary
The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, HIV
- What is being tested?
- Motivational intervention, Brief Advice and Interactive text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to 20 Jan 2022
- 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
- Healthy volunteers accepted
- 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 have drunk more than 14 drinks per week over the past 3 months
- have a confirmed diagnosis of HIV
- be a biological male who identifies as male
- report having had sex (oral or anal) with a male partner in the past 12 months and/or, identify as gay or bisexual.
- For those on ART, they must be stabilized on their current regimen for at least 3 months prior to study enrollment.
Who cannot join
- report past 3 month intravenous drug use
- are currently psychotic, suicidal, or manic
- 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
2 sites in 1 country.
United States2 sites
Fenway Health
Boston, Massachusetts
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, 02912
About this study
The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months.
Read the detailed description
Heavy drinking in HIV-infected patients can lead to low antiretroviral therapy adherence and poor virologic control, greater sexual risk taking, increased risk of liver disease, and decreased cognitive function. Therefore, reductions in drinking may have particularly positive and widespread effects in HIV-infected patients. Men who have sex with men (MSM) continue to represent the majority of new HIV infections, and HIV-infected MSM have rates of hazardous drinking as high as 33%. Therefore, developing and testing interventions to reduce heavy drinking in HIV-infected MSM is a very high public health priority. There have been relatively few alcohol interventions tested that focus on MSM, and only two have addressed drinking in HIV-infected MSM. Although recent studies indicate that behavioral interventions can reduce heavy drinking in HIV-infected patients, much remains unknown about the efficacy of different approaches to behavioral intervention and their unique and combined effects. The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months. BA and MI will be delivered by a core set of interventionists from a central location using a webcam-enabled telemedicine system, which can facilitate larger-scale implementation. The design will allow us to test the hypothesis that MI compared to BA, ITM compared to no ITM, and EI compared to no EI, will result in significantly greater reductions in number of alcoholic drinks consumed and number of heavy drinking days at 6- and 12-month follow-ups. Secondary outcomes include engagement in unprotected anal intercourse, ART adherence and viral suppression, CD4 cell count, liver function tests, and neurocognitive function. We also will test the hypothesis that the effects of MI, ITM, and EI on drinking will be moderated by alcohol use disorder status and readiness to change drinking such that these interventions will be relatively more efficacious in those with a current disorder and those with low readiness. The study will provide crucial evidence regarding which intervention approaches, alone or in combination, are likely to be most efficient to implement on a large scale in HIV care settings.
- Conditions
- Alcohol Drinking, HIV
- Being tested
- Motivational intervention, Brief Advice, Interactive text messaging
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interventionBehavioural
Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.
Brief AdviceBehavioural
Involves 5-10 minutes of brief counseling to reduce drinking
Interactive text messagingBehavioural
Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals.
| Study group | Role | What they receive |
|---|---|---|
| MI | Active comparator | Motivational interviewing focused on reducing alcohol use, delivered by videoconferencing. Receives: Behavioral: Motivational intervention |
| BA | Active comparator | Brief Advice to reduce drinking delivered by videoconferencing Receives: Behavioral: Brief Advice |
| MI + ITM | Active comparator | Motivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Receives: Behavioral: Motivational intervention; Behavioral: Interactive text messaging |
| BA + ITM | Active comparator | Brief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use Receives: Behavioral: Brief Advice; Behavioral: Interactive text messaging |
| MI + ITM + EI | Active comparator | Participants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1 Receives: Behavioral: Motivational intervention; Behavioral: Interactive text messaging |
| BA + ITM + EI | Active comparator | Participants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1 Receives: Behavioral: Brief Advice; Behavioral: Interactive text messaging |
| BA + EI | Active comparator | Participants in this arm receive BA delivered by videoconferencing over 9 months rather than 1 Receives: Behavioral: Brief Advice; Behavioral: Interactive text messaging |
| MI + EI | Active comparator | Participants in this arm receive MI delivered by videoconferencing over 9 months rather than 1 Receives: Behavioral: Motivational intervention; Behavioral: Interactive text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Drinks Per Week at 6 Months
Average number of alcoholic drinks consumed per week assessed at 6 months. Covers the period of 30 days prior to the assessment.
Measured: Past 30 days
Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months
Average number of alcoholic drinks consumed per week assessed at 12 months. Covers the period of 30 days prior to the assessment.
Measured: Past 30 days
Number of Heavy Drinking Days at 6 Months
Number of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 months
Measured: Past 30 days
Number of Heavy Drinking Days at 12 Months
Number of days drinking 5 or more alcoholic drinks
Measured: Past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2021
- Study completion20 Jan 2022
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 Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher W. Kahler, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709759
- Sponsor's protocol ID
- P01AA01907
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2016
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kahler CW, Surace A, Liu T, Pantalone DW, Mastroleo NR, Yan Y, Wray TB, Mayer KH, Monti PM. Efficacy of Behavioral Intervention, Text Messaging, and Extended Intervention to Address Alcohol Misuse in Sexual Minority Men with HIV: A Factorial Randomized Clinical Trial. AIDS Behav. 2024 Dec;28(12):3970-3983. doi: 10.1007/s10461-024-04493-x. Epub 2024 Sep 13.
PubMed 39266891
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care
- ClinicalTrials.gov ID
- NCT02709759
- Acronym / sponsor ID
- P01AA01907
- Conditions
- Alcohol Drinking, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Posted 22 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months.
Detailed description
Heavy drinking in HIV-infected patients can lead to low antiretroviral therapy adherence and poor virologic control, greater sexual risk taking, increased risk of liver disease, and decreased cognitive function. Therefore, reductions in drinking may have particularly positive and widespread effects in HIV-infected patients. Men who have sex with men (MSM) continue to represent the majority of new HIV infections, and HIV-infected MSM have rates of hazardous drinking as high as 33%. Therefore, developing and testing interventions to reduce heavy drinking in HIV-infected MSM is a very high public health priority. There have been relatively few alcohol interventions tested that focus on MSM, and only two have addressed drinking in HIV-infected MSM. Although recent studies indicate that behavioral interventions can reduce heavy drinking in HIV-infected patients, much remains unknown about the efficacy of different approaches to behavioral intervention and their unique and combined effects. The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months. BA and MI will be delivered by a core set of interventionists from a central location using a webcam-enabled telemedicine system, which can facilitate larger-scale implementation. The design will allow us to test the hypothesis that MI compared to BA, ITM compared to no ITM, and EI compared to no EI, will result in significantly greater reductions in number of alcoholic drinks consumed and number of heavy drinking days at 6- and 12-month follow-ups. Secondary outcomes include engagement in unprotected anal intercourse, ART adherence and viral suppression, CD4 cell count, liver function tests, and neurocognitive function. We also will test the hypothesis that the effects of MI, ITM, and EI on drinking will be moderated by alcohol use disorder status and readiness to change drinking such that these interventions will be relatively more efficacious in those with a current disorder and those with low readiness. The study will provide crucial evidence regarding which intervention approaches, alone or in combination, are likely to be most efficient to implement on a large scale in HIV care settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| MI | Active comparator | Behavioral: Motivational interventionMotivational interviewing focused on reducing alcohol use, delivered by videoconferencing. |
| BA | Active comparator | Behavioral: Brief AdviceBrief Advice to reduce drinking delivered by videoconferencing |
| MI + ITM | Active comparator | Behavioral: Motivational intervention, Behavioral: Interactive text messagingMotivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use |
| BA + ITM | Active comparator | Behavioral: Brief Advice, Behavioral: Interactive text messagingBrief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use |
| MI + ITM + EI | Active comparator | Behavioral: Motivational intervention, Behavioral: Interactive text messagingParticipants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1 |
| BA + ITM + EI | Active comparator | Behavioral: Brief Advice, Behavioral: Interactive text messagingParticipants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1 |
| BA + EI | Active comparator | Behavioral: Brief Advice, Behavioral: Interactive text messagingParticipants in this arm receive BA delivered by videoconferencing over 9 months rather than 1 |
| MI + EI | Active comparator | Behavioral: Motivational intervention, Behavioral: Interactive text messagingParticipants in this arm receive MI delivered by videoconferencing over 9 months rather than 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be at least 18 years of age
- drink heavily at least once per month on average (≥5 drinks) or drink have drunk more than 14 drinks per week over the past 3 months
- have a confirmed diagnosis of HIV
- be a biological male who identifies as male
- report having had sex (oral or anal) with a male partner in the past 12 months and/or, identify as gay or bisexual.
Key exclusion criteria (4 listed)
- report past 3 month intravenous drug use
- are currently psychotic, suicidal, or manic
- 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 |
|---|---|---|
| Motivational interventionInvolves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors. | Behavioural | MI, MI + EI, MI + ITM, MI + ITM + EI |
| Brief AdviceInvolves 5-10 minutes of brief counseling to reduce drinking | Behavioural | BA, BA + EI, BA + ITM, BA + ITM + EI |
| Interactive text messagingInvolves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals. | Behavioural | BA + EI, BA + ITM, BA + ITM + EI, MI + EI, MI + ITM, MI + ITM + EI |
Primary outcome
Average Number of Drinks Per Week at 6 Months
Time frame: Past 30 days
Average number of alcoholic drinks consumed per week assessed at 6 months. Covers the period of 30 days prior to the assessment.
Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months
Time frame: Past 30 days
Average number of alcoholic drinks consumed per week assessed at 12 months. Covers the period of 30 days prior to the assessment.
Number of Heavy Drinking Days at 6 Months
Time frame: Past 30 days
Number of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 months
Number of Heavy Drinking Days at 12 Months
Time frame: Past 30 days
Number of days drinking 5 or more alcoholic drinks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39266891Kahler CW, Surace A, Liu T, Pantalone DW, Mastroleo NR, Yan Y, Wray TB, Mayer KH, Monti PM. Efficacy of Behavioral Intervention, Text Messaging, and Extended Intervention to Address Alcohol Misuse in Sexual Minority Men with HIV: A Factorial Randomized Clinical Trial. AIDS Behav. 2024 Dec;28(12):3970-3983. doi: 10.1007/s10461-024-04493-x. Epub 2024 Sep 13.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational intervention, Brief Advice and Interactive text messaging in people with Alcohol Drinking and HIV, run by Brown University at 2 sites 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 6 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 22 Aug 2024). 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?
Average Number of Drinks Per Week at 6 Months (time frame: Past 30 days). The study lists 4 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 NCT02709759, 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 22 Aug 2024.