HIV InfectionsNCT03435783

Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing

A study testing Brief Electronic Intervention in people with HIV Infections and Alcohol Abuse, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections, Alcohol Abuse
What is being tested?: Brief Electronic Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 13 Oct 2017to 3 Mar 2018
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

Biologically male
Aged 18 or older
Fluent English speaker
Unprotected anal sex with a casual male partner at least once in the past 3 months
Heavy alcohol use during the past 2-weeks (>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion)
Breath alcohol concentration (BrAC) of .000 at the time of enrollment
No history of complex alcohol withdrawal
HIV-negative

Who cannot join

Individuals who are HIV-positive
Individuals who participated in other phases of the research
Individuals who report being coerced to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

Brown University School of Public Health
Providence, Rhode Island, 02901

Other trials in United States

About this study

The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.

Conditions: HIV Infections, Alcohol Abuse
Being tested: Brief Electronic Intervention, Attention-Matched Control
Medical subject headings: HIV Infections, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief Electronic InterventionBehavioural
The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so.
Attention-Matched ControlBehavioural
Participants will view a video clip on general health promotion that is a similar length as the intervention arm.

Study groups in NCT03435783
Study group	Role	What they receive
Intervention	Experimental	Not described Receives: Behavioral: Brief Electronic Intervention
Attention-matched control	Active comparator	Not described Receives: Behavioral: Attention-Matched Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of New Sex Partners, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB)
Measured: Past 30 days
Number of Condomless Anal Sex Events, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.
Measured: Past 30 days
Number of Drinking Days, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30
Measured: Past 30 days
Number of Heavy Drinking Days (5 or More), Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.
Measured: Past 30 days
Average Number of Drinks Per Drinking Day
Assessed using Timeline Follow Back (TLFB)
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.

13 Oct 20173 Mar 2018

First posted19 Feb 2018
Study start13 Oct 2017
Primary completion3 Mar 2018
Study completion3 Mar 2018

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.
Other trials for HIV InfectionsStudies 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: Prevention
Allocation: Randomised
Intervention model: Single group
Model description: Randomized controlled trial where participants are assigned to either a treatment or control group.
Masking: Single blind
Who is masked: Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03435783
Sponsor's protocol ID: 1411001155
Status last verified: Apr 2019
First submitted: 2 Aug 2017
Last updated: 23 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
ClinicalTrials.gov ID: NCT03435783
Acronym / sponsor ID: 1411001155
Conditions: HIV Infections, Alcohol Abuse
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Brown UniversityUniversity, hospital or other
Study start: 13 Oct 2017 (actual)
Primary completion: 3 Mar 2018 (actual)
Study completion: 3 Mar 2018 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 23 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (investigator)
Number of arms: 2
Model description: Randomized controlled trial where participants are assigned to either a treatment or control group.

Arm	Type	Receives
Intervention	Experimental	Behavioral: Brief Electronic Intervention
Attention-matched control	Active comparator	Behavioral: Attention-Matched Control

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Biologically male
Aged 18 or older
Fluent English speaker
Unprotected anal sex with a casual male partner at least once in the past 3 months
Heavy alcohol use during the past 2-weeks (>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion)

Key exclusion criteria (3 listed)

Individuals who are HIV-positive
Individuals who participated in other phases of the research
Individuals who report being coerced to participate

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 Electronic InterventionThe brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so.	Behavioural	Intervention
Attention-Matched ControlParticipants will view a video clip on general health promotion that is a similar length as the intervention arm.	Behavioural	Attention-matched control

Primary outcome

Number of New Sex Partners, Past 30 Days
Time frame: Past 30 days
Assessed via self-report using Timeline Follow Back (TLFB)
Number of Condomless Anal Sex Events, Past 30 Days
Time frame: Past 30 days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.
Number of Drinking Days, Past 30 Days
Time frame: Past 30 days
Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30
Number of Heavy Drinking Days (5 or More), Past 30 Days
Time frame: Past 30 days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.
Average Number of Drinks Per Drinking Day
Time frame: Past 30 days
Assessed using Timeline Follow Back (TLFB)

Results and safety

Results posted to the registry on 23 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Post-test Counseling (Control)	20	20
Brief Web-based Intervention	20	19

Primary outcome: Number of New Sex Partners, Past 30 Days

Time frame: Past 30 days. Mean (Standard Deviation). Unit: New partners

Measure	Standard Post-test Counseling (Control) n = 20	Brief Web-based Intervention n = 20
Value	2.53 (3.6)	1.37 (1.2)

Primary outcome: Number of Condomless Anal Sex Events, Past 30 Days

Time frame: Past 30 days. Mean (Standard Deviation). Unit: Events

Measure	Standard Post-test Counseling (Control) n = 20	Brief Web-based Intervention n = 20
Value	1.06 (1.6)	1.08 (1.3)

Primary outcome: Number of Drinking Days, Past 30 Days

Time frame: Past 30 days. Mean (Standard Deviation). Unit: Days

Measure	Standard Post-test Counseling (Control) n = 20	Brief Web-based Intervention n = 20
Value	10.8 (6.9)	7.04 (5.0)

Primary outcome: Number of Heavy Drinking Days (5 or More), Past 30 Days

Time frame: Past 30 days. Mean (Standard Deviation). Unit: Days

Measure	Standard Post-test Counseling (Control) n = 20	Brief Web-based Intervention n = 20
Value	3.83 (3.6)	2.67 (1.8)

Adverse events

Time frame: 3 months (the duration of the study period for all participants).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Post-test Counseling (Control)	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Brief Web-based Intervention	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
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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.

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 Electronic Intervention in people with HIV Infections and Alcohol Abuse, 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 8 inclusion and 3 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 23 Apr 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 23 Apr 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 New Sex Partners, Past 30 Days (time frame: Past 30 days). The study lists 5 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 NCT03435783.

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 23 Apr 2019.