Alcohol; Harmful UseNCT01125371

Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women

A study testing Computerized brief alcohol intervention + IVR booster calls and Computerized brief alcohol intervention in people with Alcohol; Harmful Use and Binge Drinking, run by Johns Hopkins 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 to 90 years, women onlyHealthy volunteers can take part
Conditions the study is for: Alcohol; Harmful Use, Binge Drinking, Risk Behavior
What is being tested?: Computerized brief alcohol intervention + IVR booster calls and Computerized brief alcohol intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 439 participants
Where: 1 siteUnited States
Study dates: Oct 2011to 7 Jun 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 to 90 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years of age or older;
HIV infected or HIV negative and attending the Baltimore City Health Department sexually transmitted infection clinic for STI-related services
Consumes an average of 8 or more drinks per week OR has had two binge drinking episodes (4 drinks/occasion) in the last 3 months
sexually active
Cognitively able to understand proposed research design (10 min screening, followed by random assignment to one of three study groups (if individual fulfills criteria for RCT enrollment);
Able to speak and understand English
Able and willing to receive text messages

Who cannot join

Pregnant women will be excluded and referred directly to social work for referral to either alcohol or drug treatment due to ethical concerns of randomization to usual care.
Currently enrolled in alcohol or drug treatment.
Non-English Speaking.
Actively Psychotic or have other severe mental health symptoms that would prevent appropriate participation in the brief intervention protocol.
Planning on moving out of the area within 12 months of study entry

Trial locations and contacts

1 site in 1 country.

United States1 site

Baltimore City Health Department STD Clinic
Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women

African American (AA) women are disproportionately affected by HIV/AIDs. The major risk factor for HIV acquisition among AA women is high-risk heterosexual sex, including unprotected vaginal and anal sex, and sex with a high-risk partner. Hazardous alcohol use has been associated with high risk sexual behaviors and prevalent gonorrhea among women attending an urban STI clinic, both of which increase a woman's vulnerability to HIV acquisition and transmission. This application proposes a randomized controlled trial (RCT) of a culturally tailored computer-directed brief alcohol intervention (CBI) enhanced with cell-phone booster calls using interactive voice response technology (IVR) and text messages among HIV-infected and at-risk AA women attending an urban STI Clinic. Hazardous drinking AA women (N=450) presenting with STI complaints will be randomized to one of three arms: 1) usual clinical care, 2) clinic-based, CBI, or 3) clinic-based, CBI + 3 booster calls using IVR and text messages. The CBI, an evidence-based based method for behavior change, will use principles of motivational interviewing, to counsel on: 1) alcohol use and 2) associated HIV/STI risk behaviors. Primary outcomes, measured at 3, 6, and 12 month intervals, include alcohol-related risk behaviors (number of binge drinking episodes, drinking days/week, and drinks per occasion), sexual risk behaviors (number of partners, episodes of unprotected vaginal/anal sex, episodes of sex while high), and occurrence of HIV/STI biomarkers. Prior to implementing the RCT, the CBI and IVR software messages will be revised to: 1) include the association between hazardous alcohol use and risky sexual behaviors, and 2) ensure their relevance and acceptability using quantitative/qualitative feedback from a sample of AA women attending a Baltimore City STI clinic. The proposed research focuses on a particularly vulnerable population of urban HIV at-risk and HIV-infected AA women seeking treatment in a public STI clinic and examines two novel BI intervention delivery strategies specifically tailored to be culturally/socially relevant to this minority population. If the intervention(s) prove to be effective, study findings will offer "real life" specialty care clinics a screening and intervention package that is practical, low cost, and easy to implement.

Conditions: Alcohol; Harmful Use, Binge Drinking, Risk Behavior, HIV Infection
Being tested: Computerized brief alcohol intervention + IVR booster calls, Computerized brief alcohol intervention, Attention Control
Keywords: Hazardous alcohol use, Binge drinking, High risk sexual behaviors, HIV risk reduction
Medical subject headings: Binge Drinking, Risk-Taking, HIV Infections

What participants receive

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

Computerized brief alcohol intervention + IVR booster callsBehavioural
Also called CBI+IVR+TM
1. Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
Computerized brief alcohol interventionBehavioural
Also called CBI
Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
Attention ControlBehavioural
Attention Control: 20 minute attention control condition focused on dental hygiene delivered once

Study groups in NCT01125371
Study group	Role	What they receive
Computerized Brief Alcohol Intervention + IVR	Experimental	Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM) Receives: Behavioral: Computerized brief alcohol intervention + IVR booster calls
Computerized Brief Alcohol Intervention	Active comparator	Computerized Brief Alcohol Intervention only (CBI) Receives: Behavioral: Computerized brief alcohol intervention
Attention Control	Placebo comparator	Attention control Receives: Behavioral: Attention Control

What is being measured

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

Change in Alcohol Use (Heavy Drinking Days)
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
Measured: Baseline, 3, 6, and 12 months
Change in Alcohol Use (Drinking Days)
Change in alcohol-related risk behavior as assessed by the number of drinking days.
Measured: Baseline, 3, 6, and 12 months
Change in Alcohol Use (Drinks Per Drinking Day)
Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.
Measured: Baseline, 3, 6, and 12 months
Change in Alcohol Use (Drinks Per Week)
Change in alcohol-related risk behavior as assessed by the standard drinks per week.
Measured: Baseline, 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 20117 Jun 2016

First posted18 May 2010 (estimated)
Study startOct 2011
Primary completion7 Jun 2016
Study completion7 Jun 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.
Other trials for Alcohol; Harmful UseStudies of the same condition, open and under way.
More trials run by Johns Hopkins 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 439 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01125371
Sponsor's protocol ID: NIAAAGC018632
Other IDs: R01AA018632
Status last verified: Jun 2022
First submitted: 17 May 2010
Last updated: 24 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 Alcohol; Harmful Use trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women
ClinicalTrials.gov ID: NCT01125371
Acronym / sponsor ID: NIAAAGC018632
Conditions: Alcohol; Harmful Use, Binge Drinking, Risk Behavior, HIV Infection
Keywords: Hazardous alcohol use, Binge drinking, High risk sexual behaviors, HIV risk reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 439 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Oct 2011
Primary completion: 7 Jun 2016 (actual)
Study completion: 7 Jun 2016 (actual)
First posted: 18 May 2010 (estimated)
Results: Posted 24 Jun 2022

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Computerized Brief Alcohol Intervention + IVR	Experimental	Behavioral: Computerized brief alcohol intervention + IVR booster callsComputer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Computerized Brief Alcohol Intervention	Active comparator	Behavioral: Computerized brief alcohol interventionComputerized Brief Alcohol Intervention only (CBI)
Attention Control	Placebo comparator	Behavioral: Attention ControlAttention control

Who may qualify

Ages: 18 to 90 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

18 years of age or older;
HIV infected or HIV negative and attending the Baltimore City Health Department sexually transmitted infection clinic for STI-related services
Consumes an average of 8 or more drinks per week OR has had two binge drinking episodes (4 drinks/occasion) in the last 3 months
sexually active
Cognitively able to understand proposed research design (10 min screening, followed by random assignment to one of three study groups (if individual fulfills criteria for RCT enrollment);

Key exclusion criteria (5 listed)

Pregnant women will be excluded and referred directly to social work for referral to either alcohol or drug treatment due to ethical concerns of randomization to usual care.
Currently enrolled in alcohol or drug treatment.
Non-English Speaking.
Actively Psychotic or have other severe mental health symptoms that would prevent appropriate participation in the brief intervention protocol.
Planning on moving out of the area within 12 months of study entry

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
Computerized brief alcohol intervention + IVR booster callsAlso: CBI+IVR+TM1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages	Behavioural	Computerized Brief Alcohol Intervention + IVR
Computerized brief alcohol interventionAlso: CBIComputerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time	Behavioural	Computerized Brief Alcohol Intervention
Attention ControlAttention Control: 20 minute attention control condition focused on dental hygiene delivered once	Behavioural	Attention Control

Primary outcome

Change in Alcohol Use (Heavy Drinking Days)
Time frame: Baseline, 3, 6, and 12 months
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
Change in Alcohol Use (Drinking Days)
Time frame: Baseline, 3, 6, and 12 months
Change in alcohol-related risk behavior as assessed by the number of drinking days.
Change in Alcohol Use (Drinks Per Drinking Day)
Time frame: Baseline, 3, 6, and 12 months
Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.
Change in Alcohol Use (Drinks Per Week)
Time frame: Baseline, 3, 6, and 12 months
Change in alcohol-related risk behavior as assessed by the standard drinks per week.

Results and safety

Results posted to the registry on 24 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Computerized Brief Alcohol Intervention + IVR	146	120
Computerized Brief Alcohol Intervention	145	130
Attention Control	148	129

Primary outcome: Change in Alcohol Use (Heavy Drinking Days)

Time frame: Baseline, 3, 6, and 12 months. Median (Inter-Quartile Range). Unit: heavy drinking days

Measure	Computerized Brief Alcohol Intervention + IVR n = 146	Computerized Brief Alcohol Intervention n = 145	Attention Control n = 148
Baseline	6 (2 to 13)	6 (3 to 11)	6 (2 to 11)
3 months	3 (1 to 7)	3 (1 to 8)	3 (0 to 8)
6 months	3 (0 to 7)	4 (1 to 8)	2 (0 to 8)
12 months	2 (0 to 6)	2 (0 to 6)	3 (1 to 6)

Population analysed: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.

Primary outcome: Change in Alcohol Use (Drinking Days)

Time frame: Baseline, 3, 6, and 12 months. Median (Inter-Quartile Range). Unit: drinking days

Measure	Computerized Brief Alcohol Intervention + IVR n = 146	Computerized Brief Alcohol Intervention n = 145	Attention Control n = 148
Baseline	9 (5 to 15)	9 (6 to 14)	8.5 (5.8 to 15)
3 months	6.4 (3 to 10)	7 (4 to 12)	6 (2.1 to 11)
6 months	6 (2 to 11)	7 (2 to 12)	5 (2 to 11)
12 months	6 (2 to 11)	6 (2 to 11)	6 (2 to 10)

Population analysed: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.

Primary outcome: Change in Alcohol Use (Drinks Per Drinking Day)

Time frame: Baseline, 3, 6, and 12 months. Median (Inter-Quartile Range). Unit: drinks per drinking day

Measure	Computerized Brief Alcohol Intervention + IVR n = 146	Computerized Brief Alcohol Intervention n = 145	Attention Control n = 148
Baseline	5.6 (3.2 to 8.8)	5.6 (3.3 to 9.3)	6.1 (3.7 to 7.8)
3 months	3.7 (2.2 to 6.2)	4.2 (2.3 to 6.4)	4.1 (2.0 to 6.5)
6 months	3.8 (1.4 to 6.4)	4.4 (2.1 to 6.8)	3.8 (1.7 to 6.2)
12 months	3.0 (1.5 to 5.7)	3.4 (1.4 to 5.6)	3.8 (1.4 to 6.5)

Population analysed: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.

Primary outcome: Change in Alcohol Use (Drinks Per Week)

Time frame: Baseline, 3, 6, and 12 months. Median (Inter-Quartile Range). Unit: drinks per week

Measure	Computerized Brief Alcohol Intervention + IVR n = 146	Computerized Brief Alcohol Intervention n = 145	Attention Control n = 148
Baseline	12.0 (4.7 to 28.7)	12.4 (5.8 to 25.5)	12.0 (5.3 to 25.3)
3 months	6.5 (2.1 to 13.6)	7.0 (2.9 to 15.4)	6.4 (1.6 to 16.1)
6 months	5.6 (1.1 to 13.1)	6.8 (1.4 to 15.7)	4.4 (0.9 to 15.7)
12 months	4.3 (1.0 to 11.5)	5.3 (1.0 to 12.4)	5.4 (1.4 to 11.2)

Population analysed: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Computerized Brief Alcohol Intervention + IVR	0 of 146 (0%)	0 of 146 (0%)	1 of 146
Computerized Brief Alcohol Intervention	0 of 145 (0%)	0 of 145 (0%)	0 of 145
Attention Control	0 of 148 (0%)	0 of 148 (0%)	1 of 148

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Geetanjali Chander, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 5 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 24 Jun 2022. 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. Some participants in this study may receive a placebo. 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 24 Jun 2022). 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?

Change in Alcohol Use (Heavy Drinking Days) (time frame: Baseline, 3, 6, and 12 months). 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 NCT01125371.

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 24 Jun 2022.