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

• Sponsor: Boston Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02869776
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 18.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV; Hepatitis C	Behavioral: Questionnaire; Procedure: Rapid finger stick; Procedure: Venipuncture	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jul 26, 2017
• Actual Study Completion Date: Jul 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rapid finger stick HIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered.	Behavioral: Questionnaire; Behavioral questionnaires; Procedure: Rapid finger stick; HIV and HCV testing through rapid finger stick
Experimental: Standard venipuncture HIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered.	Behavioral: Questionnaire; Behavioral questionnaires; Procedure: Venipuncture; HIV and HCV testing through venipuncture

Outcome Measures

Primary Outcome Measures

1. Number of participants who receive HCV test results [within 5 days (by the time of discharge from the detoxification center)]

   The number of participants who receive HCV test results by the time they are discharged from the detoxification center

2. Number of participants who receive HIV test results [within 5 days (by the time of discharge from the detoxification center)]

   The number of participants who receive HIV test results by the time they are discharged from the detoxification center

Secondary Outcome Measures

1. Number of participants who link to HCV care [by three months]

   The number of participants who are seen for an HCV visit

2. Number of participants who have HCV RNA testing [by three months]

   The number of participants who have HCV RNA testing performed

3. Number of participants who have fibrosis staging performed [by three months]

   The number participants who have fibrosis staging performed

4. Number of participants who have HCV treatment initiated [by six months]

   The number participants who have HCV treatment initiated

5. Number of participants who reach sustained virologic response [by twelve months]

   The number participants who reach sustained virologic response

6. Number of participants who link to HIV care [by 3 months]

   The number participants who are seen for an HIV visit

7. Number of participants who HIV RNA testing [by 3 months]

   The number participants who have HIV RNA testing

8. Number of participants who have CD4 testing [by 3 months]

   The number participants who have CD4 testing

9. Number of participants who have antiretroviral treatment initiated [by 3 months]

   The number participants who initiated antiretroviral treatment

10. Number of participants who achieve HIV viral suppression [by 6 months]

    The number participants who achieve HIV viral suppression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston Medical Center
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Sabrina Assoumou, MD, MPH, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT02869776
• Other Study ID Numbers: H-35271; RA25035163 -01A 1; 5P30AI042853-18
• First Posted: Aug 17, 2016
• Last Update Posted: Dec 11, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis C

Study Results

No Results Posted as of Dec 11, 2020