Comparative sensitivity of automated (Abbott M2000) and manual plasma HIV-1 RNA PCR assays for the detection of persistent viremia after long-term antiretroviral therapy

Tosiano, Melissa A.; Mar, Hanna; Hoeth, Dianna; Eron, Joseph J.; Gandhi, Rajesh T.; McMahon, Deborah; Bosch, Ronald J.; Mellors, John W.; Cyktor, Joshua C.

doi:10.1016/j.jve.2022.100095

Cited by 2 publications

(3 citation statements)

References 20 publications

(21 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Plasma samples will be processed to obtain HIV-1 RNA viral load concentrations at the Epicenter Mbarara Research Base using the Abbott HIV-1 assay. This test is > 90% sensitive and specific [ 45 – 47 ]. The secondary outcomes will be (1) (re)linkage to care within 7 days; (2) ART (re)initiation; (3) ART adherence at 12 months after linkage to care, defined as a binary outcome of hair tenofovir concentration (> 0.023 ng/mg, reflecting four or more ART doses per week); and (4) retention in HIV clinic care after 12 months [ 48 , 49 ].…”

Section: Methodsmentioning

confidence: 99%

Traditional healer support to improve HIV viral suppression in rural Uganda (Omuyambi): study protocol for a cluster randomized hybrid effectiveness-implementation trial

Sundararajan,

Hooda,

Lai

et al. 2024

Trials

View full text Add to dashboard Cite

Background Rural African people living with HIV face significant challenges in entering and remaining in HIV care. In rural Uganda, for example, there is a threefold higher prevalence of HIV compared to the national average and lower engagement throughout the HIV continuum of care. There is an urgent need for appropriate interventions to improve entry and retention in HIV care for rural Ugandans with HIV. Though many adults living with HIV in rural areas prioritize seeking care services from traditional healers over formal clinical services, healers have not been integrated into HIV care programs. The Omuyambi trial is investigating the effectiveness of psychosocial support delivered by traditional healers as an adjunct to standard HIV care versus standard clinic-based HIV care alone. Additionally, we are evaluating the implementation process and outcomes, following the Consolidated Framework for Implementation Research. Methods This cluster randomized hybrid type 1 effectiveness-implementation trial will be conducted among 44 traditional healers in two districts of southwestern Uganda. Healers were randomized 1:1 into study arms, where healers in the intervention arm will provide 12 months of psychosocial support to adults with unsuppressed HIV viral loads receiving care at their practices. A total of 650 adults with unsuppressed HIV viral loads will be recruited from healer clusters in the Mbarara and Rwampara districts. The primary study outcome is HIV viral load measured at 12 months after enrollment, which will be analyzed by intention-to-treat. Secondary clinical outcome measures include (re)initiation of HIV care, antiretroviral therapy adherence, and retention in care. The implementation outcomes of adoption, fidelity, appropriateness, and acceptability will be evaluated through key informant interviews and structured surveys at baseline, 3, 9, 12, and 24 months. Sustainability will be measured through HIV viral load measurements at 24 months following enrollment. Discussion The Omuyambi trial is evaluating an approach that could improve HIV outcomes by incorporating previously overlooked community lay supporters into the HIV cascade of care. These findings could provide effectiveness and implementation evidence to guide the development of policies and programs aimed at improving HIV outcomes in rural Uganda and other countries where healers play an essential role in community health. Trial registration ClinicalTrials.gov NCT05943548. Registered on July 5, 2023. The current protocol version is 4.0 (September 29, 2023).

show abstract

Section: Methodsmentioning

confidence: 99%

Traditional healer support to improve HIV viral suppression in rural Uganda (Omuyambi): study protocol for a cluster randomized hybrid effectiveness-implementation trial

Sundararajan,

Hooda,

Lai

et al. 2024

Trials

View full text Add to dashboard Cite

show abstract

“…The current diagnostic methods for AIDS mainly rely on HIV antibodies and antigens and include virus neutralization, serological tests, and enzyme-linked immunosorbent assays. − Due to the low level of HIV antibody in the early stage, these methods have good specificity but lack high sensitivity, making early detection of HIV difficult. In addition, these approaches generally require expensive instruments and equipment, special reagents, professional operators, and exceptionally long analysis times. , These requirements are increasingly recognized as difficult to meet in underdeveloped and remote epidemic areas and even in cities when epidemics peak. Therefore, there is an urgent need to develop fast, easily operated, low-budget, and portable point-of-care (POC) testing facilities that enable the convenient and timely monitoring of patients for HIV infection in a community or home setting. − …”

Section: Introductionmentioning

confidence: 99%

“…In addition, these approaches generally require expensive instruments and equipment, special reagents, professional operators, and exceptionally long analysis times. 6 , 7 These requirements are increasingly recognized as difficult to meet in underdeveloped and remote epidemic areas and even in cities when epidemics peak. Therefore, there is an urgent need to develop fast, easily operated, low-budget, and portable point-of-care (POC) testing facilities that enable the convenient and timely monitoring of patients for HIV infection in a community or home setting.…”

Section: Introductionmentioning

confidence: 99%

Novel DNA Biosensing Platform for Detecting HIV Integrase for Highly Sensitive and Quantitative HIV Detection, Diagnosis, and Therapeutic Monitoring

Chen,

Wang,

et al. 2024

ACS Omega

View full text Add to dashboard Cite

Straightforward, sensitive, and specific human immunodeficiency virus (HIV) assays are urgently needed. The creation of a point-of-care (POC) device for decentralized diagnostics has the potential to significantly reduce the time to treatment, especially for infectious diseases. Notably, however, many POC solutions proposed to date fall short of meeting the ASSURED guidelines, which are crucial for effective deployment in the field. Herein, we developed a DNA biosensor platform for the specific and quantitative detection of HIV. The platform contains a rolling circle amplification (RCA)-based DNA biosensor and a portable fluorescence detector, in which HIV-encoded integrase (IN) enzyme activity is used as a biomarker to achieve HIV-specific detection. The cleavage and integration reaction of IN on the sensor surface and RCA are combined in this detection platform to perform detection signal cascade amplification, ultimately achieving a detection limit of 0.125 CFU/μL of HIV particles. Moreover, the DNA sensor system exhibited high sensitivity and accuracy for detecting HIV in clinical samples, suggesting that it has potential for application in clinical settings to detect retroviruses other than HIV. In addition, quantitative detection based on this biosensing platform was significantly correlated with the CD4+ lymphocytes count, which can provide guidance for antiretroviral therapy and which affects long-term death risk assessment in HIV patients. Therefore, this DNA biosensing platform based on IN activity is expected to be useful for rapid HIV testing, diagnosis, and treatment monitoring, enabling the development of new POC diagnostic tests and will thus be highly valuable for developing HIV prevention strategies and effective treatments.

show abstract

Comparative sensitivity of automated (Abbott M2000) and manual plasma HIV-1 RNA PCR assays for the detection of persistent viremia after long-term antiretroviral therapy

Cited by 2 publications

References 20 publications

Traditional healer support to improve HIV viral suppression in rural Uganda (Omuyambi): study protocol for a cluster randomized hybrid effectiveness-implementation trial

Traditional healer support to improve HIV viral suppression in rural Uganda (Omuyambi): study protocol for a cluster randomized hybrid effectiveness-implementation trial

Novel DNA Biosensing Platform for Detecting HIV Integrase for Highly Sensitive and Quantitative HIV Detection, Diagnosis, and Therapeutic Monitoring

Contact Info

Product

Resources

About