NCT01419899

Brief Summary

The purpose of this study is to determine if a brief intervention delivered to emergency department patients increases the uptake of rapid HIV and hepatitis C testing in comparison to no brief intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
398

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

July 6, 2011

Last Update Submit

August 5, 2013

Conditions

Drug UseHIVHepatitis C

Keywords

Brief interventionRapid testing

Outcome Measures

Primary Outcomes (1)

  • The agreement of the participant to be tested for HIV and hepatitis C

    We will measure the acceptance of free rapid testing for HIV and hepatitis C among the intervention and control groups

    Within four hours of being consented into the study

Secondary Outcomes (1)

  • Identifying risky sexual behaviors of study participants

    Within four hours of being consented into the study

Study Arms (2)

Brief Intervention

EXPERIMENTAL

This arm of the study will receive an assessments survey followed by a brief intervention concerning the relationship between the participants use of drugs and/or sexual risk and rik for HIV and hepatitis C infections. Following the intervention the participants will be offered free rapid testing for HIV and hepatitis C.

Behavioral: Brief motivational intervention

Standard Care

NO INTERVENTION

This arm of the study will receive an assessments survey. Following the assessment the participants will be offered free rapid testing for HIV and hepatitis C.

Interventions

Brief motivational interventionBEHAVIORAL

A 20-30 minute motivational based discussion

Brief Intervention

Eligibility Criteria

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

You may qualify if:

  • Emergency department patient.
  • Does not know HIV or hepatitis C status.
  • Has an ASSIST V3 score that indicates recent illicit and/or prescription drug use.
  • Fluency in English or Spanish.

You may not qualify if:

  • Critically ill or injured.
  • Homicidal and/or suicidal intention.
  • Age \< 18 years or \> 64 years.
  • Does not speak English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital Emergency Department

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

  • Bernardino VL, Baird JR, Liu T, Merchant RC. Comparison of substance-use prevalence among Rhode Island and The Miriam Hospital Emergency Department patients to state and national general population prevalence estimates. R I Med J (2013). 2014 Apr 1;98(4):30-4.

    PMID: 25830171DERIVED

  • Merchant RC, Baird JR, Liu T, Taylor LE, Montague BT, Nirenberg TD. Brief intervention to increase emergency department uptake of combined rapid human immunodeficiency virus and hepatitis C screening among a drug misusing population. Acad Emerg Med. 2014 Jul;21(7):752-67. doi: 10.1111/acem.12419.

    PMID: 25125271DERIVED

  • Merchant RC, Baird JR, Liu T, Taylor LE. HCV among The Miriam Hospital and Rhode Island Hospital Adult ED Patients. R I Med J (2013). 2014 Jul 1;97(7):35-9.

    PMID: 24983020DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Roland C Merchant, MD, ScD

    Brown University

    PRINCIPAL INVESTIGATOR

  • Ted D Nirenberg, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 6, 2011

First Posted

August 18, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

US(1)