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Sponsor: Johns Hopkins University
Conditions: HIV Infections, Syphilis
Interventions: Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system, OraQuick
Countries: United States
This study proposes to investigate the performance of existing and new technologies for HIV diagnosis, one of the key strategies for Ending the HIV Epidemic in the U.S. Current, Standard-of-Care (SOC) diagnostic techniques have extended turn-around-times (TATs) that result in loss of patients to follow up due to delays in laboratory procedures. In this scenario, patients that are at a high-risk for HIV have the potential to continue transmission, making it difficult to end the epidemic. Rapid, Point-of-Care (POC) HIV viral load (VL) testing alleviates this problem by reducing TATs that allow providers to test for HIV infection and link patients to antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) during the same clinical visit, and subsequently, suppress VL, prevent HIV infection, and reduce its transmission among high-risk populations. The study proposes that evaluating the performance of new and existing POC technologies is needed to provide updated information to HIV test providers operating in different populations and settings and improve linkage to HIV treatment and prevention services. The study hypothesizes that: A. Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings B. The use of HIV RNA POC tests will improve linkage to HIV treatment and prevention services: i. Improve early diagnosis of HIV ii. Reduce the time to ART initiation iii. Facilitate timely and appropriate referral for prevention services
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Aged 18 years or older * Living with or at high risk for HIV (MSM/transgender; injection drug use (IDU); known STI or being screened for STI; part of a high STI prevalence network \[e.g., in the Sexual Health clinic\]) * Willing to undergo phlebotomy and collection of oral fluid samples * Willing to complete a questionnaire * Willing to have laboratory results shared with the clinician(s) associated with their care * Willing to attend follow-up visits * Willing for samples to be transferred to the CDC for analysis and storage Exclusion Criteria: * Aged \<18 years * Unwilling to undergo study procedures * Any other reason deemed pertinent by the study team
- Baltimore, Maryland, United States
- Baltimore, Maryland, United States
- Baltimore, Maryland, United States