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OpenTrials
Completed

NCT Number: NCT02869776

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

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.

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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

Behavioral questionnaires

Rapid finger stick

Procedure

HIV and HCV testing through rapid finger stick

Venipuncture

Procedure

HIV and HCV testing through venipuncture

Primary outcomes

  1. Number of participants who receive HCV test results

    Time frame: 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

    Time frame: 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 outcomes

  1. Number of participants who link to HCV care

    Time frame: by three months

    The number of participants who are seen for an HCV visit

  2. Number of participants who have HCV RNA testing

    Time frame: by three months

    The number of participants who have HCV RNA testing performed

  3. Number of participants who have fibrosis staging performed

    Time frame: by three months

    The number participants who have fibrosis staging performed

  4. Number of participants who have HCV treatment initiated

    Time frame: by six months

    The number participants who have HCV treatment initiated

  5. Number of participants who reach sustained virologic response

    Time frame: by twelve months

    The number participants who reach sustained virologic response

  6. Number of participants who link to HIV care

    Time frame: by 3 months

    The number participants who are seen for an HIV visit

  7. Number of participants who HIV RNA testing

    Time frame: by 3 months

    The number participants who have HIV RNA testing

  8. Number of participants who have CD4 testing

    Time frame: by 3 months

    The number participants who have CD4 testing

  9. Number of participants who have antiretroviral treatment initiated

    Time frame: by 3 months

    The number participants who initiated antiretroviral treatment

  10. Number of participants who achieve HIV viral suppression

    Time frame: by 6 months

    The number participants who achieve HIV viral suppression

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2016
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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