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

NCT ID: NCT02869776

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-26

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rapid finger stick

HIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered.

Group Type EXPERIMENTAL

Questionnaire

Intervention Type BEHAVIORAL

Behavioral questionnaires

Rapid finger stick

Intervention Type PROCEDURE

HIV and HCV testing through rapid finger stick

Standard venipuncture

HIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered.

Group Type EXPERIMENTAL

Questionnaire

Intervention Type BEHAVIORAL

Behavioral questionnaires

Venipuncture

Intervention Type PROCEDURE

HIV and HCV testing through venipuncture

Interventions

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Questionnaire

Behavioral questionnaires

Intervention Type BEHAVIORAL

Rapid finger stick

HIV and HCV testing through rapid finger stick

Intervention Type PROCEDURE

Venipuncture

HIV and HCV testing through venipuncture

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabrina Assoumou, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Assoumou SA, Paniagua SM, Gonzalez P, Wang J, Beckwith CG, White LF, Taylor JL, Coogan K, Samet JH, Linas BP. HIV Pre-exposure Prophylaxis and Buprenorphine at a Drug Detoxification Center During the Opioid Epidemic: Opportunities and Challenges. AIDS Behav. 2021 Aug;25(8):2591-2598. doi: 10.1007/s10461-021-03220-0. Epub 2021 Mar 22.

Reference Type DERIVED
PMID: 33751315 (View on PubMed)

Assoumou SA, Paniagua SM, Linas BP, Wang J, Samet JH, Hall J, White LF, Beckwith CG. Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C at a Drug Detoxification Treatment Center: A Randomized Trial. J Infect Dis. 2020 Sep 2;222(Suppl 5):S376-S383. doi: 10.1093/infdis/jiaa162.

Reference Type DERIVED
PMID: 32877557 (View on PubMed)

Other Identifiers

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RA25035163 -01A 1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5P30AI042853-18

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-35271

Identifier Type: -

Identifier Source: org_study_id