Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341081
Status:
COMPLETED
Last Update Posted:
2011-05-25
First Post:
2006-06-19
Brief Title:
Validation of Self-Reported Needle Sharing Among Injection Drug Users
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Validation of Self-Reported Needle Sharing Among Injection Drug Users
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 individuals checking in and returning the syringe to alleles 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-N029 | None | None | None |