HIV Diagnostics: Current Recommendations and Opportunities for Improvement.

Profound changes in technology have revolutionized laboratory testing for human immunodeficiency virus (HIV) since the first laboratory enzyme immunoassays that detected only immunoglobulin G (IgG) antibodies. Instrumented fourth-generation random-access chemiluminescent assays are now recommended for initial screening because they become reactive in as little as 2 weeks after infection. Using HIV-1 RNA viral load assays after a reactive initial test could confirm infection and provide useful clinical information.

Direct Diagnostic Tests for Lyme Disease.

Borrelia burgdorferi was discovered to be the cause of Lyme disease in 1983, leading to seroassays. The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings.

It's all in the timing: Acceptability of a financial incentive intervention for linkage to HIV care in the HPTN 065 (TLC-Plus) study.

The HPTN 065 (TLC-Plus) study tested the feasibility and effectiveness of using financial incentives (FIs) to increase linkage to care (L2C) among individuals with newly diagnosed HIV and those out of care in the Bronx, NY and Washington, DC. Qualitative data collection with a subset of participating patients and staff focused on experiences with and attitudes about the FI intervention. Semi-structured interviews were conducted with 15 patients and 14 site investigators.

Acute HIV Discovered During Routine HIV Screening With HIV Antigen-Antibody Combination Tests in 9 US Emergency Departments.

Study Objective: Newer combination HIV antigen-antibody tests allow detection of HIV sooner after infection than previous antibody-only immunoassays because, in addition to HIV-1 and -2 antibodies, they detect the HIV-1 p24 antigen, which appears before antibodies develop. We determine the yield of screening with HIV antigen-antibody tests and clinical presentations for new diagnoses of acute and established HIV infection across US emergency departments (EDs).

Methods: This was a retrospective study of 9 EDs in 6 cities with HIV screening programs that integrated laboratory-based antigen-antibody tests between November 1, 2012, and December 31, 2015.

Advances in Serodiagnostic Testing for Lyme Disease Are at Hand.

The cause of Lyme disease, Borrelia burgdorferi, was discovered in 1983. A 2-tiered testing protocol was established for serodiagnosis in 1994, involving an enzyme immunoassay (EIA) or indirect fluorescence antibody, followed (if reactive) by immunoglobulin M and immunoglobulin G Western immunoblots. These assays were prepared from whole-cell cultured B.

Expanding Hospital Human Immunodeficiency Virus Testing in the Bronx, New York and Washington, District of Columbia: Results From the HPTN 065 Study.

Background: Human immunodeficiency virus (HIV) testing is critical for both HIV treatment and prevention. Expanding testing in hospital settings can identify undiagnosed HIV infections.

Methods: To evaluate the feasibility of universally offering HIV testing during emergency department (ED) visits and inpatient admissions, 9 hospitals in the Bronx, New York and 7 in Washington, District of Columbia (DC) undertook efforts to offer HIV testing routinely.

A Randomized-Controlled Trial of Computer-based Prevention Counseling for HIV-Positive Persons (HPTN 065).

Objective: Decreasing the risk of HIV transmission from HIV-positive individuals is an important public health priority. We evaluated the effectiveness of a computer-based sexual risk reduction counseling intervention (CARE+) among HIV-positive persons enrolled in care.

Methods: HIV-positive eligible participants (N=1075) were enrolled from 11 care sites in the Bronx, NY and Washington, DC and randomized 1:1 to either a tablet-based self-administered CARE+ intervention or standard of care (SOC).

Financial Incentives for Linkage to Care and Viral Suppression Among HIV-Positive Patients: A Randomized Clinical Trial (HPTN 065).

Importance: Achieving linkage to care and viral suppression in human immunodeficiency virus (HIV)-positive patients improves their well-being and prevents new infections. Current gaps in the HIV care continuum substantially limit such benefits.

Objective: To evaluate the effectiveness of financial incentives on linkage to care and viral suppression in HIV-positive patients.

Design of the HPTN 065 (TLC-Plus) study: A study to evaluate the feasibility of an enhanced test, link-to-care, plus treat approach for HIV prevention in the United States.

Background/Aims HIV continues to be a major public health threat in the United States, and mathematical modeling has demonstrated that the universal effective use of antiretroviral therapy among all HIV-positive individuals (i.e. the "test and treat" approach) has the potential to control HIV.

The Role of Financial Incentives Along the Antiretroviral Therapy Adherence Continuum: A Qualitative Sub-study of the HPTN 065 (TLC-Plus) Study.

The stages of change (SOC) theory suggests individuals adapt incrementally to behaviors like adherence, requiring different strategies over the behavior change continuum. Offering financial incentives (FIs) is one strategy to motivate adherence. This qualitative sub-study examined adherence barriers and the role of FIs to increase viral suppression (VS) among HIV Prevention Trials Network (HPTN) 065 study participants categorized into SOC-related adherence stages based on changes from baseline to follow-up viral load tests.

"It Makes You Feel Like Someone Cares" acceptability of a financial incentive intervention for HIV viral suppression in the HPTN 065 (TLC-Plus) study.

Background: HPTN 065 (TLC-Plus) evaluated the feasibility and effectiveness of providing quarterly $70 gift card financial incentives to HIV-infected patients on antiretroviral therapy (ART) to encourage ART adherence and viral suppression, and represents the largest study to-date of a financial incentive intervention for HIV viral suppression. A post-trial qualitative substudy was undertaken to examine acceptability of the financial incentives among those receiving and implementing the intervention.

Methods: Between July and October 2013, semi-structured interviews were conducted with 72 patients and 12 investigators from 14 sites; three focus groups were conducted with 12 staff from 10 sites.

Changing Clinician Practices and Attitudes Regarding the Use of Antiretroviral Therapy for HIV Treatment and Prevention.

As part of the HPTN 065 study in the Bronx, New York and Washington, the authors, we surveyed clinicians to assess for shifts in their practices and attitudes around HIV treatment and prevention. Antiretroviral therapy (ART)-prescribing clinicians at 39 HIV care sites were offered an anonymous Web-based survey at baseline (2010-2011) and at follow-up (2013). The 165 respondents at baseline and 141 respondents at follow-up had similar characteristics-almost 60% were female, median age was 47 years, two-thirds were physicians, and nearly 80% were HIV specialists.

Costs of Expanded Rapid HIV Testing in Four Emergency Departments.

Objective: The HIV Prevention Trials Network (HPTN) 065 trial sought to expand HIV screening of emergency department (ED) patients in Bronx, New York, and Washington, D.C. This study assessed the testing costs associated with different expansion processes and compared them with costs of a hypothetical optimized process.

HIV Testing among Outpatients with Medicaid and Commercial Insurance.

Objective: To assess HIV testing and factors associated with receipt of testing among persons with Medicaid and commercial insurance during 2012.

Methods: Outpatient and laboratory claims were analyzed from two databases: all Medicaid claims from six states and all claims from Medicaid health plans from four other states and a large national convenience sample of patients with commercial insurance in the United States. We excluded those aged <13 years and >64 years, enrolled <9 of the 12 months, pregnant females, and previously diagnosed with HIV.

Monitoring HIV Testing in the United States: Consequences of Methodology Changes to National Surveys.

Objective: In 2011, the National Health Interview Survey (NHIS), an in-person household interview, revised the human immunodeficiency virus (HIV) section of the survey and the Behavioral Risk Factor Surveillance System (BRFSS), a telephone-based survey, added cellphone numbers to its sampling frame. We sought to determine how these changes might affect assessment of HIV testing trends.

Methods: We used linear regression with pairwise contrasts with 2003-2013 data from NHIS and BRFSS to compare percentages of persons aged 18-64 years who reported HIV testing in landline versus cellphone-only households before and after 2011, when NHIS revised its in-person questionnaire and BRFSS added cellphone numbers to its telephone-based sample.

HIV testing updates and challenges: when regulatory caution and public health imperatives collide.

Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25 years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster turnaround times for test results. These play an important role in identifying HIV infection during the highly infectious acute phase, which has implication for both patient management and public health interventions to control the spread of HIV.

Acceptability of home self-tests for HIV in New York City, 2006.

Data from a 2006 telephone survey representative of New York City adults showed that more than half (56.2%) of those aged 18 to 64 years responded favorably to a question about acceptability of a rapid home HIV test. More than two thirds of certain subpopulations at high risk for HIV reported that they would use a rapid home HIV test, but approximately half who expressed interest had indications of financial hardship.

Routine HIV screening in two health-care settings--New York City and New Orleans, 2011-2013.

Approximately 16% of the estimated 1.1 million persons living with human immunodeficiency virus (HIV) in the United States are unaware of their infection and thus unable to benefit from effective treatment that improves health and reduces transmission risk. Since 2006, CDC has recommended that health-care providers screen for HIV all patients aged 13-64 years unless prevalence of undiagnosed HIV infection in their patients has been documented to be <0.

HIV and hepatitis C virus infection in the United States: whom and how to test.

In the United States, of the 1.1 million persons infected with human immunodeficiency virus (HIV) and the 2.7 million infected with hepatitis C virus (HCV), approximately 16% and 50%, respectively, are unaware of their infection.

Costs and outcomes of laboratory diagnostic algorithms for the detection of HIV.

Background: An alternative HIV testing algorithm, designed to improve the detection of acute and early infections and differentiate between HIV-1 and HIV-2 antibodies, has been developed by the Centers for Disease Control and Prevention and the Association of Public Health Laboratories. While it promises greater sensitivity, it also raises concerns about costs.

Objective: We sought to compare the most commonly used algorithm which was developed in 1989, a third-generation (3G) immunoassay (IA) and Western blot confirmatory test, to a newer algorithm.

Relative accuracy of serum, whole blood, and oral fluid HIV tests among Seattle men who have sex with men.

Background: Point-of-care (POC) rapid HIV tests have sensitivity during the "window period" comparable only to earliest generation EIAs. To date, it is unclear whether any POC test performs significantly better than others.

Objective: Compare abilities of POC tests to detect early infection in real time.

Evaluation of supplemental testing with the Multispot HIV-1/HIV-2 Rapid Test and APTIMA HIV-1 RNA Qualitative Assay to resolve specimens with indeterminate or negative HIV-1 Western blots.

Background: The use of Western blot (WB) as a supplemental test after reactive sensitive initial assays can lead to inconclusive or misclassified HIV test results, delaying diagnosis.

Objective: To determine the proportion of specimens reactive by immunoassay (IA) but indeterminate or negative by WB that could be resolved by alternative supplemental tests recommended under a new HIV diagnostic testing algorithm.

Study Design: Remnant HIV diagnostic specimens that were reactive on 3rd generation HIV-1/2 IA and either negative or indeterminate by HIV-1 WB from 11 health departments were tested with the Bio-Rad Multispot HIV-1/HIV-2 Rapid Test (Multispot) and the Gen-Probe APTIMA HIV-1 RNA Qualitative Assay (APTIMA).

Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial.

Importance: To increase human immunodeficiency virus (HIV) testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process.

Objective: To assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs).