Validation of Self-Reported Needle Sharing Among Injection Drug Users
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||May 24, 2011|
|Start Date ICMJE||October 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00341081 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Validation of Self-Reported Needle Sharing Among Injection Drug Users|
|Official Title ICMJE||Validation of Self-Reported Needle Sharing Among Injection Drug Users|
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Viral Infection|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||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. No abstract available.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
All efforts in BNEP and ALIVE were made to recruit as many IDUs as possible without any discrimination based on sex or race.
Individuals under 18 years of age have been excluded from the study.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00341081|
|Other Study ID Numbers ICMJE||999903029, 03-C-N029|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP