NCT01573065

Brief Summary

The purpose of this study was to determine whether a brief counseling intervention coupled with rapid HIV testing was feasible and effective at decreasing alcohol consumption and sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

April 4, 2012

Last Update Submit

August 9, 2012

Conditions

Alcohol ConsumptionSexual Risk Behaviors

Keywords

alcohol consumptionsexual risk behaviorsyoung, unhealthy drinkers

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    number of patients enrolled and retained at 2 months.

    baseline and 2 month follow-up

Secondary Outcomes (2)

  • Alcohol consumption

    baseline vs. 2 month follow-up

  • Sexual risk behaviors

    baseline vs. 2 month follow-up

Study Arms (1)

Single arm

EXPERIMENTAL
Behavioral: Counseling intervention with rapid HIV testing

Interventions

Counseling intervention with rapid HIV testingBEHAVIORAL

Counseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing. Telephone booster at 2 weeks.

Single arm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old;
  • engaged in at least one sexual risk behavior in past 90 days;
  • alcohol consumption greater than NIAAA guidelines for at-risk drinking;
  • unknown or negative HIV status and willing to be tested;
  • able to provide contact information for follow-up;
  • able to provide written informed consent.

You may not qualify if:

  • known HIV positive status;
  • medically or psychiatrically unstable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital Emergency Deparmtment

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Counseling

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lynn E Fiellin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 6, 2012

Study Start

March 1, 2010

Primary Completion

May 1, 2010

Study Completion

August 1, 2011

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

US(1)