NCT00341081

Brief Summary

This study, conducted at the Johns Hopkins University School of Public Health in Baltimore, Maryland, will determine how accurately injection drug users report their needle-sharing behavior. Needle-sharing is a major cause of blood-borne diseases, including HIV and hepatitis. Therefore, a better understanding of this behavior is critical for devising strategies to reduce disease spread in this way. Research on needle-sharing behavior has relied heavily on users' self-reports. This study will compare these self-reports with results of DNA tests that show whether a needle has been used by one or more individuals. Injection drug users 18 years of age or older participating in the Baltimore Needle Exchange Program (BNEP) have been recruited for this study. Syringes distributed to users through the BNEP are collected after use and tested to differentiate between single versus multiple users. The findings are compared with the participants' responses about whether or not they shared their needles and syringes. Participants visit the clinic every 6 months for an interview, including questions about their mental and physical health, drug use, sexual activity and knowledge about HIV (the virus that causes AIDS) and AIDS. After the interview, a small amount of blood is drawn for testing for HIV, hepatitis, syphilis and other infectious diseases. Some of the blood is stored for future testing. Participants return to the clinic 4 weeks after the interview and blood drawing to get their test results. At this time, they are offered referral for drug treatment, free condoms, advice about drug use and safer sex and an opportunity to ask questions about their health. Participation in the study may continue for up to 5 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
442

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2002

Longer than P75 for all trials

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

October 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 25, 2011

Status Verified

May 1, 2011

First QC Date

June 19, 2006

Last Update Submit

May 24, 2011

Conditions

Keywords

Short Tandem RepeatMolecular EpidemiologyViral InfectionMixture DetectionIntervention & EducationInterventionEducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All efforts in BNEP and ALIVE were made to recruit as many IDUs as possible without any discrimination based on sex or race.

You may not qualify if:

  • Individuals under 18 years of age have been excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • Rezza G, Pizzuti R, De Campora E, De Masi S, Vlahov D. Tetanus and injections drug use: rediscovery of a neglected problem? Eur J Epidemiol. 1996 Dec;12(6):655-6. doi: 10.1007/BF00499469. No abstract available.

    PMID: 8982630BACKGROUND

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

October 1, 2002

Study Completion

June 1, 2007

Last Updated

May 25, 2011

Record last verified: 2011-05

Locations