Clinical trial NCT02869776: Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
Official title: Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hepatitis C
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who receive HCV test results
timeFrame: within 5 days (by the time of discharge from the detoxification center)
measure: Number of participants who receive HIV test results
timeFrame: within 5 days (by the time of discharge from the detoxification center)
Secondary outcomes:
measure: Number of participants who link to HCV care
timeFrame: by three months
measure: Number of participants who have HCV RNA testing
timeFrame: by three months
measure: Number of participants who have fibrosis staging performed
timeFrame: by three months
measure: Number of participants who have HCV treatment initiated
timeFrame: by six months
measure: Number of participants who reach sustained virologic response
timeFrame: by twelve months
measure: Number of participants who link to HIV care
timeFrame: by 3 months
measure: Number of participants who HIV RNA testing
timeFrame: by 3 months
measure: Number of participants who have CD4 testing
timeFrame: by 3 months
measure: Number of participants who have antiretroviral treatment initiated
timeFrame: by 3 months
measure: Number of participants who achieve HIV viral suppression
timeFrame: by 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Sabrina Assoumou, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.