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Validation of Self-Reported Needle Sharing Among Injection Drug Users

Primary Purpose

Viral Infection

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Viral Infection focused on measuring Short Tandem Repeat, Molecular Epidemiology, Viral Infection, Mixture Detection, Intervention & Education, Intervention, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: All efforts in BNEP and ALIVE were made to recruit as many IDUs as possible without any discrimination based on sex or race. EXCLUSION CRITERIA: Individuals under 18 years of age have been excluded from the study.

Sites / Locations

  • Johns Hopkins University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 19, 2006
Last Updated
May 24, 2011
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00341081
Brief Title
Validation of Self-Reported Needle Sharing Among Injection Drug Users
Official Title
Validation of Self-Reported Needle Sharing Among Injection Drug Users
Study Type
Observational

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
Needle sharing is a major cause of blood-borne diseases making understanding needle sharing behavior imperative to devising strategies to reduce the disease burden. A DNA-based method, using highly informative genetic markers of short tandem repeats (STRs) is being proposed as a gold standard measure to identify single-use and multi-use syringes. Self-reports of needle sharing, which have been the main source of sharing information for research, will be compared to the genotypic results to validate the responses on such risk behavior. Genotypic information from four autosomal STRs will be used to differentiate DNA from a single versus multiple individuals in syringe exudates obtained from injection drug users (IDUs) from the Baltimore needle exchange program (BNEP) studied by ALIVE II. Detecting three or more distinct alleles at an autosomal STR in the syringe exudates provides evidence that the syringe has been shared by at least two individuals. Matching probabilities will be used to match the genotypic profile of the individual(s) checking in and returning the syringe to allele(s) observed in the syringe exudates, and a mixture discrimination probability will be used to measure the likelihood of single vs. multi genome in the syringe samples. Behavioral surveillance to document the rapid spread of infectious disease from needle sharing among high-risk sub-population such as IDUs are critical for global public health along with the development and implementation of timely interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Infection
Keywords
Short Tandem Repeat, Molecular Epidemiology, Viral Infection, Mixture Detection, Intervention & Education, Intervention, Education

7. Study Design

Enrollment
442 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: All efforts in BNEP and ALIVE were made to recruit as many IDUs as possible without any discrimination based on sex or race. EXCLUSION CRITERIA: Individuals under 18 years of age have been excluded from the study.
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8982630
Citation
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.
Results Reference
background

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Validation of Self-Reported Needle Sharing Among Injection Drug Users

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