Integrating HCV and HIV Screening During the Era of HIV Antigen Testing

HIV Clinical Trial

Official title:

Integrating HCV and HIV Screening During the Era of HIV Antigen Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869776
• Other study ID #: H-35271
• Secondary ID: RA25035163 -01A
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 26, 2017

Study information

• Verified date: December 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in high prevalence settings, such as detoxification centers with a large proportion of young injection drug users. The latest venipuncture testing will be compared to rapid finger stick testing for HCV and HIV. Outcomes for each strategy among individuals admitted at a short-term drug detoxification center will be determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 26, 2017
• Est. primary completion date: July 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater or equal to 18
• All clients admitted to BTC with a history of drug or alcohol use
• Individuals who self-report as being HIV and HCV non-infected within the past 6 months or having unknown status
• Participants providing contact information of two family members or friends
• Individuals signing a medical records release form for the referral site (Boston Medical Center)
• English speaking

Exclusion Criteria:

• Individuals unable to provide informed consent
• Individuals with a known history of HCV and/or HIV

Related Conditions & MeSH terms

• Hepatitis C
• HIV

Intervention

Behavioral:
• Questionnaire
Behavioral questionnaires

Procedure:
• Rapid finger stick
HIV and HCV testing through rapid finger stick
• Venipuncture
HIV and HCV testing through venipuncture

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who receive HCV test results	The number of participants who receive HCV test results by the time they are discharged from the detoxification center	within 5 days (by the time of discharge from the detoxification center)
Primary	Number of participants who receive HIV test results	The number of participants who receive HIV test results by the time they are discharged from the detoxification center	within 5 days (by the time of discharge from the detoxification center)
Secondary	Number of participants who link to HCV care	The number of participants who are seen for an HCV visit	by three months
Secondary	Number of participants who have HCV RNA testing	The number of participants who have HCV RNA testing performed	by three months
Secondary	Number of participants who have fibrosis staging performed	The number participants who have fibrosis staging performed	by three months
Secondary	Number of participants who have HCV treatment initiated	The number participants who have HCV treatment initiated	by six months
Secondary	Number of participants who reach sustained virologic response	The number participants who reach sustained virologic response	by twelve months
Secondary	Number of participants who link to HIV care	The number participants who are seen for an HIV visit	by 3 months
Secondary	Number of participants who HIV RNA testing	The number participants who have HIV RNA testing	by 3 months
Secondary	Number of participants who have CD4 testing	The number participants who have CD4 testing	by 3 months
Secondary	Number of participants who have antiretroviral treatment initiated	The number participants who initiated antiretroviral treatment	by 3 months
Secondary	Number of participants who achieve HIV viral suppression	The number participants who achieve HIV viral suppression	by 6 months