scholarly journals Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT

10.2196/16332 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e16332 ◽  
Author(s):  
Joanne D Stekler ◽  
Lauren R Violette ◽  
Hollie A Clark ◽  
Sarah J McDougal ◽  
Lisa A Niemann ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Prospective Study ◽  
Hiv Testing ◽  
Transmitted Disease ◽  
The United States ◽  
Test Results ◽  
Cross Sectional ◽  
Hiv Test ◽  
Hiv Acquisition ◽  
Hiv 1

Background HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. Objective This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. Methods Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. Results Between September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. Conclusions Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. International Registered Report Identifier (IRRID) RR1-10.2196/16332

scholarly journals Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT (Preprint)

2019 ◽  
Author(s):  
Joanne D Stekler ◽  
Lauren R Violette ◽  
Hollie A Clark ◽  
Sarah J McDougal ◽  
Lisa A Niemann ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Prospective Study ◽  
Hiv Testing ◽  
Transmitted Disease ◽  
The United States ◽  
Test Results ◽  
Cross Sectional ◽  
Hiv Test ◽  
Hiv Acquisition ◽  
Hiv 1

BACKGROUND HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. OBJECTIVE This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. METHODS Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. RESULTS Between September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. CONCLUSIONS Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. INTERNATIONAL REGISTERED REPORT RR1-10.2196/16332

scholarly journals Routine HIV Test Results in 6 US Clinical Laboratories Using the Recommended Laboratory HIV Testing Algorithm With Geenius HIV 1/2 Supplemental Assay

2020 ◽  
Vol 47 ◽  
pp. S13-S17 ◽  
Author(s):  
Laura G. Wesolowski ◽  
Pollyanna R. Chavez ◽  
Ana María Cárdenas ◽  
Alex Katayev ◽  
Patricia Slev ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Test Results ◽  
Clinical Laboratories ◽  
Hiv Test ◽  
Testing Algorithm ◽  
Hiv 1

HIV Testing Behaviors Among Latina Women Tested for HIV in Florida, 2012

2017 ◽  
Vol 15 (1) ◽  
pp. 27-34 ◽  
Author(s):  
Janelle Taveras ◽  
Mary Jo Trepka ◽  
Purnima Madhivanan ◽  
Erica L. Gollub ◽  
Jessy Devieux ◽  
...  
Keyword(s):  
United States ◽  
Hiv Testing ◽  
The United States ◽  
Test Results ◽  
Publicly Funded ◽  
Latina Women ◽  
Prevention Services ◽  
Hiv Test ◽  
Immunodeficiency Virus ◽  
Racial Ethnic

Introduction: Latina women in the United States (US) are not only disproportionately affected by human immunodeficiency virus (HIV) infection but also underuse HIV prevention services, such as HIV testing. Method: HIV testing events were examined to describe the HIV testing behaviors and test results among Latinas tested in 2012 at publicly funded sites in Florida, United States. Multivariable logistic regression was used to assess the demographic characteristics associated with reports of previous testing and positive HIV test results. Results: Of the 184,037 testing events, 87,569 (45.6%) were among non-Hispanic Blacks (NHBs), 47,926 (26.0%) non-Hispanic Whites (NHWs), 41,117 (22.3%) Latinas, 5,672 (3.1%) those with unknown race/ethnicity, and 1,753 (1.0%) other racial/ethnic groups. Compared to NHW and NHB women, Latinas testing for HIV were older (mean age = 32.1, NHW = mean age 30.3, NHB = mean age 30.0; p < .0001). Results indicated that women who reported previous HIV testing had decreased odds of being Latina (adjusted odds ratio = 0.90; 95% confidence interval [0.87, 0.94]). Conclusion: These findings indicate that Latinas are underusing HIV testing, and efforts are needed to increase the proportion of Latinas, especially younger Latinas, tested for HIV in Florida.

scholarly journals Absence of routine molecular testing and prevalence of HIV-2 infection in regions hardest-hit by HIV infection

2012 ◽  
Vol 6 (12) ◽  
pp. 854-859 ◽  
Author(s):  
Joseph C Forbi ◽  
Mathew D Esona ◽  
Hellen O Iperepolu ◽  
Moses P Adoga ◽  
Simon M Agwale
Keyword(s):  
Hiv Infection ◽  
Sex Workers ◽  
False Negative ◽  
Rapid Test ◽  
Molecular Testing ◽  
Test Results ◽  
Active Population ◽  
Hiv Test ◽  
In Series ◽  
Hiv 1

Introduction: Investigating the incidence and dynamics of HIV-2 and false-negative HIV test results in a highly sexually active population where frequent opportunities exist for acquiring and transmitting infections provides additional understanding of the epidemiology of the virus in Africa. Methodology: The HIV status of 900 active female sex workers (FSWs) was determined using two lateral flow rapid assays in series. The second rapid test device incorporates type-specific recombinant peptides that discriminate between HIV-1 and HIV-2 infection. HIV sero-negative samples were re-tested for HIV infection and their viral loads determined using the NucliSENS real-time nucleic acid sequence-based amplification (NASBA) platform. Results: In total, 335 FSWs were determined to be HIV positive, the majority (227; 67.8%) of whom were between the ages of 20 and 30 years. Eighteen (5.4%) were found to have evidence of HIV-2 infection, 17 of whom were co-infected with HIV-1. Only one HIV-2 mono-infection was observed. Out of 565 HIV-negative individuals determined by serology, 11(1.9%; p>0.05) were found to be HIV-1 positive when tested via the NASBA platform. Conclusion: False negative test results, HIV-2 infection, and complex transmission networks among FSWs may aid in fueling the HIV epidemic in the Nigerian population. These findings demonstrate the need to reevaluate the quality of HIV serological diagnostics, control services, and stress the need for widespread introduction of molecular testing among high-risk populations in the country.

Home HIV Testing and Conflicts with State HIV Testing Regulations

1995 ◽  
Vol 21 (4) ◽  
pp. 419-444
Author(s):  
William O. Fabbri
Keyword(s):  
Hiv Testing ◽  
The United States ◽  
Hiv Positive ◽  
State Governments ◽  
Test Results ◽  
Health Departments ◽  
Hiv Counseling ◽  
Public Health Departments ◽  
Hiv Test ◽  
Set Up

Currently the number of AIDS-related deaths in the United States has reached 311,000 and at least one million more Americans are infected with HIV. Of those one million or more infected, many spread the virus unknowingly as approximately forty percent of those infected have never been tested. More than eighty-five percent of the U.S. population has never been tested for HIV. No cure or vaccine for HIV currently exists.The federal and state governments have set up a patchwork of free and confidential HIV testing at local clinics. States have enacted a variety of legislation concerning HIV testing and test results. Most states have enacted statutes that require informed consent for an HIV test to be conducted. All states require the reporting of AIDS cases, and many also require the reporting of HIV-positive status to state public health departments. Furthermore, many states mandate certain requirements for HIV counseling.

scholarly journals Uptake of provider-initiated HIV and syphilis testing among heterosexual STD clinic patients in Guangdong, China: results from a cross-sectional study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041503
Author(s):  
Peizhen Zhao ◽  
Weiming Tang ◽  
Huanhuan Cheng ◽  
Shujie Huang ◽  
Heping Zheng ◽  
...  
Keyword(s):  
Condom Use ◽  
Hiv Testing ◽  
Transmitted Disease ◽  
Cross Sectional Study ◽  
Health Priorities ◽  
Consistent Condom ◽  
Sectional Study ◽  
Cross Sectional ◽  
Syphilis Testing ◽  
Testing Uptake

ObjectivesUnderscreening of HIV and syphilis in clinical settings is pervasive in resource-constrained settings. Heavy patient loads and competing health priorities in these settings inhibit provider’s ability to meet screening coverage targets. The objective of this study was to examine determinants of provider-initiated HIV and syphilis testing uptake at sexually transmitted disease (STD) clinics in China.DesignA cross-sectional study was performed between July 2016 and December 2016.SettingSeven STD clinics in Guangdong Province, China.ParticipantsHeterosexual STD clinic patients met the inclusion criteria, regardless of their interest in receiving HIV or syphilis testing.Outcome measuresThe syphilis and HIV testing uptake determined by patient receipt of results.ResultsA total of 1943 individuals were recruited in this study. Among those participants, 60.6% (1177/1943) and 74.3% (1443/1943) conducted HIV testing and syphilis testing during the study, respectively, of whom, 2.2% (26/1177) and 21.5% (310/1443) were found to be HIV-positive and syphilis-positive, respectively. The most common reason for rejecting HIV and syphilis testing was a low self-perceived risk of HIV and syphilis infection. After adjusting for covariates, condom use in the last sexual act, consistent condom use in the last 6 months, having paid sex in the last 6 months and having received any kind of HIV/STD-related knowledge during the last 12 years were positively associated with both HIV and syphilis testing uptake.ConclusionsThe low-level of HIV and syphilis testing uptake, alongside with the high-level of engagement in risky sexual behaviours among heterosexual STD clinic patients, warranted a more targeted and intensive behavioural interventions to promote HIV and syphilis testing in this population.

scholarly journals Factors associated with HIV testing among traditional healers and their clients in rural Uganda: Results from a cross-sectional study

2021 ◽  
pp. 095646242110150
Author(s):  
Doreen Nabukalu ◽  
Matthew Ponticiello ◽  
Thomas Bennett ◽  
Sunday Clark ◽  
Rachel King ◽  
...  
Keyword(s):  
Rural Communities ◽  
Hiv Testing ◽  
Cross Sectional Study ◽  
Traditional Healers ◽  
Sectional Study ◽  
Cross Sectional ◽  
The Past ◽  
Male Clients ◽  
Hiv Test ◽  
Testing Uptake

Uptake of HIV testing is suboptimal in Uganda, particularly in rural communities. Reaching UNAIDS 95-95-95 goals requires strategies to increase HIV testing among hard-to-reach populations. This cross-sectional study sought to characterize engagement with HIV testing among traditional healers and their clients in rural Uganda. We enrolled 175 traditional healers and 392 adult clients of healers in Mbarara District. The primary outcome for this study was having received an HIV test in the prior 12 months. Most clients ( n = 236, 65.9%) had received an HIV test within 12 months, compared to less than half of healers ( n = 75, 46.3%) who had not. In multivariate regression models, male clients of healers were half as likely to have tested in the past year, compared with female (adjusted odds ratios (AORs) = 0.43, 95% CI = 0.26–0.70). Increasing age negatively predicted testing within the past year (AOR = 0.95, 95% CI = 0.93–0.97) for clients. Among healers, more sexual partners predicted knowing ones serostatus (AOR = 1.6, 95% CI 1.03–2.48). Healers (AOR = 1.16, 95% CI 1.07–1.26) and clients (AOR = 1.28, 95% CI 1.13–1.34 for clients) with greater numbers of lifetime HIV tests were more likely to have tested in the past year. Traditional healers and their clients lag behind UNAIDS benchmarks and would benefit from programs to increase HIV testing uptake.

scholarly journals Do I Have HIV or Not? Lack of RNA Detection and the Case for Sensitive DNA Testing

2020 ◽  
Vol 7 (11) ◽  
Author(s):  
Sandra A Springer ◽  
Silvina Masciotra ◽  
Jeffrey A Johnson ◽  
Sheldon Campbell
Keyword(s):  
Antiretroviral Therapy ◽  
Hiv Infection ◽  
Viral Rna ◽  
Infection Status ◽  
Test Results ◽  
Dna Testing ◽  
Rna Detection ◽  
Hiv Test

Abstract We present a case of a 20-year-old male who had ambiguous HIV test results after entering new provider care and whose status was later complicated by undetectable viral RNA off antiretroviral therapy (ART). Verifying HIV infection status may occasionally require sensitive DNA testing that might need to be considered in diagnostic guidelines to resolve diagnosis and ensure appropriate ART management.

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