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"Hyle, Emily P."
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Diagnostic point-of-care tests in resource-limited settings
The aim of diagnostic point-of-care testing is to minimise the time to obtain a test result, thereby allowing clinicians and patients to make a quick clinical decision. Because point-of-care tests are used in resource-limited settings, the benefits need to outweigh the costs. To optimise point-of-care testing in resource-limited settings, diagnostic tests need rigorous assessments focused on relevant clinical outcomes and operational costs, which differ from assessments of conventional diagnostic tests. We reviewed published studies on point-of-care testing in resource-limited settings, and found no clearly defined metric for the clinical usefulness of point-of-care testing. Therefore, we propose a framework for the assessment of point-of-care tests, and suggest and define the term test efficacy to describe the ability of a diagnostic test to support a clinical decision within its operational context. We also propose revised criteria for an ideal diagnostic point-of-care test in resource-limited settings. Through systematic assessments, comparisons between centralised testing and novel point-of-care technologies can be more formalised, and health officials can better establish which point-of-care technologies represent valuable additions to their clinical programmes.
Journal Article
The association between HIV and atherosclerotic cardiovascular disease in sub-Saharan Africa: a systematic review
Background
Sub-Saharan Africa (SSA) has confronted decades of the HIV epidemic with substantial improvements in access to life-saving antiretroviral therapy (ART). Now, with improved survival, people living with HIV (PLWH) are at increased risk for non-communicable diseases (NCDs), including atherosclerotic cardiovascular disease (CVD). We assessed the existing literature regarding the association of CVD outcomes and HIV in SSA.
Methods
We used the PRISMA guidelines to perform a systematic review of the published literature regarding the association of CVD and HIV in SSA with a focus on CVD surrogate and clinical outcomes in PLWH.
Results
From January 2000 until March 2017, 31 articles were published regarding CVD outcomes among PLWH in SSA. Data from surrogate CVD outcomes (
n
= 13) suggest an increased risk of CVD events among PLWH in SSA. Although acute coronary syndrome is reported infrequently in SSA among PLWH, limited data from five studies suggest extensive thrombus and hypercoagulability as contributing factors. Additional studies suggest an increased risk of stroke among PLWH (
n
= 13); however, most data are from immunosuppressed ART-naïve PLWH and thus are potentially confounded by the possibility of central nervous system infections.
Conclusions
Given ongoing gaps in our current understanding of CVD and other NCDs in PLWH in SSA, it is imperative to ascertain the burden of CVD outcomes, and to examine strategies for intervention and best practices to enhance the health of this vulnerable population.
Journal Article
The association between all-cause mortality and HIV acquisition risk groups in the United States, 2001–2014
To investigate associations between all-cause mortality and human immunodeficiency virus (HIV) acquisition risk groups among people without HIV in the United States. We used data from 23,657 (NHANES) participants (2001-2014) and the Linked Mortality File to classify individuals without known HIV into HIV acquisition risk groups: people who ever injected drugs (ever-PWID); men who have sex with men (MSM); heterosexually active people at increased risk for HIV (HIH), using low income as a proxy for increased risk. We used Cox proportional hazards models to estimate adjusted and unadjusted all-cause mortality hazard ratios (HR) with 95% confidence intervals (CI). Compared with sex-specific heterosexually active people at average risk for HIV (HAH), the adjusted HR (95% CI) were: male ever-PWID 1.67 (1.14, 2.46), female ever-PWID 3.50 (2.04, 6.01), MSM 1.51 (1.00, 2.27), male HIH 1.68 (1.04, 2.06), female HIH 2.35 (1.87, 2.95), and male ever-PWID 1.67 (1.14, 2.46). Most people at increased risk for HIV in the US experience higher all-cause mortality than people at average risk. Strategies addressing social determinants that increase HIV risk should be incorporated into HIV prevention and other health promotion programs.
Journal Article
Disparities in cigarette smoking and the health of marginalized populations in the U.S.: a simulation analysis
Introduction
People with low socioeconomic status (SES) or serious psychological distress (SPD) in the U.S. face ongoing and future disparities in tobacco smoking. We sought to estimate how smoking disparities contribute to disparities in life expectancy and aggregate life-years in these marginalized subpopulations.
Methods
We used the Simulation of Tobacco and Nicotine Outcomes and Policy (STOP) microsimulation model to project life expectancy as a function of subpopulation (low SES, higher SES, SPD, or non-SPD) and cigarette smoking status. Low SES was defined as having at least one of the following: income below poverty, less than high school education, or Medicaid insurance. Higher SES individuals belonged to none of these categories. SPD was defined as Kessler-6 score ≥ 13; non-SPD was a Kessler-6 score < 13. To project individual life expectancy losses from smoking, we simulated 40-year-olds stratified by gender, subpopulation (by SES or by SPD, with no change), and smoking status (current/never, with no change). To project time to reach 5% cigarette smoking prevalence (U.S.) – reflecting one tobacco “endgame” threshold – in each subpopulation, we simulated the entire subpopulations of people with low SES, higher SES, SPD, and non-SPD, incorporating corresponding distributions of gender, age, and smoking status and accounting for changes in smoking behaviors and secular smoking trends. We then estimated total life-years accumulated under status quo and alternate scenarios in which smoking dynamics in the marginalized subpopulations matched those of their less marginalized counterparts.
Results
The model showed that, for individuals with low SES or SPD, smoking is associated with substantial loss of life expectancy (9.8-11.5y). Marginalized subpopulations would reach 5% smoking prevalence 20y (low SES) and 17y (SPD) sooner if smoking trends mirrored their less marginalized counterparts; these differences result in 5.3 million (low SES) and 966,000 (SPD) excess life-years lost over 40y.
Conclusions
Differences in cigarette smoking portend substantial ongoing and future disparities in life expectancy and time to reach 5% smoking prevalence. Reducing tobacco-related disparities in the U.S. will require an explicitly equity-focused vision, and the tobacco endgame will only be truly achieved when it includes all groups.
Journal Article
Effect of containment strategies for respiratory diseases on infections imported via international travel to the USA: a modelling study
ObjectivesTo examine outcomes from respiratory pathogens containment strategies focused on international travellers.DesignWe developed a compartmental model generalisable to respiratory infectious diseases, in which international travellers interact with each other and airline/airport workers during transit. We used SARS-CoV-2 Omicron surge data (basic reproduction number (R0): 9.5) as a case example and performed sensitivity and scenario analyses, including varying the R0 for different respiratory pathogens.SettingsA US high-volume airport.ParticipantsSimulated international travellers and airline/airport workers.InterventionsProjection of new and imported SARS-CoV-2 infections without intervention (No Intervention); pre-travel screening for travellers who intend to travel (intended travellers) with PCR (Pre-travel PCR); or antigen testing (Pre-travel Ag); mask-wearing guidance for travellers and workers (Mask-wearing); and a Combined strategy (Pre-travel PCR & Mask-wearing).Outcome measuresThe number of new and imported respiratory disease infections over the 90-day simulation period.ResultsOver the 90-day simulation, the number of infected travellers entering the USA would be: 1 155 580 (27.2% of 4.2 million (M) intended travellers) with No Intervention; 709 560/4.2M (16.7%) with Pre-travel PCR; 862 330/4.2M (20.3%) with Pre-travel Ag; 1033 820/4.2M (24.4%) with Mask-wearing; and 650 480/4.2M (15.3%) with Combined. The number of new infections among airline/airport workers would be: 25 670 (73.3% of 35 000 workers) with No Intervention; 25 260 (72.2%) in Pre-travel PCR; 25 590 (73.1%) in Pre-travel Ag; 24 630 (70.4%) in Mask-wearing; and 18 770 (53.6%) in Combined. In scenario analyses, the most impactful parameters were R0 of the respiratory pathogen and population immunity level.ConclusionsA Combined strategy of pre-travel PCR testing and mask-wearing would most effectively reduce respiratory infection among international travellers and airline/airport workers, but would still allow a substantial number of infections to enter the USA, especially when the pathogen is highly transmissible.
Journal Article
Projecting lifetime HIV-related healthcare costs for youth with HIV in the United States
Background and Objectives
US youth with HIV (YHIV) face challenges to antiretroviral therapy (ART) adherence and care engagement. Understanding YHIV healthcare costs is essential for healthcare payers and for evaluating the cost-effectiveness of youth-focused interventions.
Methods
Using the CEPAC-Adolescent microsimulation model, we simulated YHIV cohorts, including those with HIV acquired perinatally (15%) and non-perinatally (85%), aged 13–24 years, in care and prescribed ART. We projected undiscounted life expectancy from model start; per-person and population-level (
n
= 24,626) lifetime HIV-related healthcare costs (discounted at 3% annually) from a health payer perspective.
Results
YHIV were projected to live 47.4 life-years after model start, with discounted lifetime HIV-related healthcare costs of $685,000/person ($1,404,000/person undiscounted). Overall, this population would accrue $16.9 billion in discounted HIV-related care costs over their lifetimes. ART medication would comprise most costs (74%), followed by routine HIV-related clinical care (22%), which would be most costly during the time spent at low CD4 counts. ART prices were the most impactful input; generic prices could reduce total lifetime costs by 62% ($264,000/person discounted).
Conclusions
We projected that US YHIV in care aged 13–24 years would incur nearly $17 billion in lifetime HIV-related healthcare costs. While total costs would increase with improved HIV-related care due to longer life expectancy, monthly costs would be highest during time spent at lower CD4 counts. ART costs would drive lifetime HIV-related healthcare costs for YHIV. Efforts to decrease ART prices and interventions to improve HIV care engagement and support consistent ART use could reduce HIV care costs and improve health outcomes for YHIV.
Journal Article
Cost-effectiveness of integrating postpartum antiretroviral therapy and infant care into maternal & child health services in South Africa
Poor engagement in postpartum maternal HIV care is a challenge worldwide and contributes to adverse maternal outcomes and vertical transmission. Our objective was to project the clinical and economic impact of integrated postpartum maternal antiretroviral therapy (ART) and pediatric care in South Africa.
Using the CEPAC computer simulation models, parameterized with data from the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) randomized controlled trial, we evaluated the cost-effectiveness of integrated postpartum care for women initiating ART in pregnancy and their children. We compared two strategies: 1) standard of care (SOC) referral to local clinics after delivery for separate standard ART services for women and pediatric care for infants, and 2) the MCH-ART intervention (MCH-ART) of co-located maternal/pediatric care integrated in Maternal and Child Health (MCH) services throughout breastfeeding. Trial-derived inputs included: 12-month maternal retention in care and virologic suppression (SOC: 49%, MCH-ART: 67%), breastfeeding duration (SOC: 6 months, MCH-ART: 8 months), and postpartum healthcare costs for mother-infant pairs (SOC: $50, MCH-ART: $69). Outcomes included pediatric HIV infections, maternal and infant life expectancy (LE), lifetime HIV-related per-person costs, and incremental cost-effectiveness ratios (ICERs; ICER
Journal Article
Vaccine completion and infectious diseases screening in a cohort of adult refugees following resettlement in the U.S.: 2013–2015
Background
Refugees are frequently not immune to vaccine-preventable infections. Adherence to consensus guidelines on vaccination and infectious diseases screening among refugees resettling in the U.S. is unknown. We sought to determine rates of vaccine completion and infectious diseases screening in refugees following resettlement.
Methods
We conducted a retrospective cohort study of refugees resettling in a region in the U.S. using medical data from June 2013–April 2015. We determined the proportion of vaccine-eligible refugees vaccinated with measles-mumps-rubella (MMR), hepatitis A/B, tetanus, diphtheria, and acellular pertussis (Tdap), and human papillomavirus (HPV) following resettlement. We also determined the proportion of refugees who completed HIV and hepatitis C (HCV) screening.
Results
One hundred and eleven subjects were included, primarily from Iraq (53%), Afghanistan (19%), and Eritrea (11%). Of the 84 subjects who were vaccine-eligible, 78 (93%) initiated and 42 (50%) completed vaccinations within one year of resettlement. Odds of completing vaccination were higher for men (OR: 2.38; 95%CI:1.02–5.71) and for subjects with English proficiency (OR: 3.70; 95%CI:1.04–17.49). Of the 78 subjects (70%) completing HIV screening, two (3%) were diagnosed with HIV. Nearly all subjects completed screening for HCV, and one had active infection.
Conclusion
While most refugees initiate vaccinations, only 50% completed vaccinations and 70% completed HIV screening within 1 year of resettlement. There is a need to emphasize vaccine completion and HIV screening in refugee patients following resettlement.
Journal Article
What does the scale‐up of long‐acting HIV pre‐exposure prophylaxis mean for the global hepatitis B epidemic?
Introduction The HIV and hepatitis B virus (HBV) epidemics are interconnected with shared routes of transmission and specific antiviral drugs that are effective against both viruses. Nearly, 300 million people around the world live with chronic HBV, many of whom are from priority populations who could benefit from HIV prevention services. Oral pre‐exposure prophylaxis (PrEP) for HIV has implications in the prevention and treatment of HBV infection, but many people at increased risk of HIV acquisition may instead prefer long‐acting formulations of PrEP, which are currently not active against HBV. Discussion People at increased risk for HIV acquisition may also be at risk for or already be living with HBV infection. Oral PrEP with tenofovir is effective in preventing both HIV and HBV, and tenofovir is also the recommended treatment for chronic HBV infection. Although implementation of oral PrEP has been challenging in sub‐Saharan Africa, investments in its scale‐up could secondarily reduce the clinical impact of HBV. Long‐acting PrEP, including injectable medicines and implantable rings, may overcome some of the implementation challenges associated with oral PrEP, such as daily pill burden, adherence challenges and stigma; however, current formulations of long‐acting PrEP do not have activity against HBV replication. Ideally, PrEP programmes would offer both oral and long‐acting formulations with HBV screening to optimize HIV prevention services and HBV prevention and care, when appropriate. People who are not immune to HBV would benefit from being vaccinated against HBV before initiating long‐acting PrEP. People who remain non‐immune to HBV despite vaccination may benefit from being offered oral, tenofovir‐based PrEP given its potential for HBV PrEP. People using PrEP and living with HBV who are not linked to dedicated HBV care would also benefit from laboratory monitoring at PrEP sites to ensure safety when using and after stopping tenofovir. PrEP programmes are ideal venues to offer HBV screening, HBV vaccination for people who are non‐immune and treatment with tenofovir‐based PrEP for people with indications for HBV therapy. Conclusions Long‐acting PrEP holds promise for reducing HIV incidence, but its implications for the HBV epidemic, particularly in sub‐Saharan Africa, should not be overlooked.
Journal Article
The Clinical and Economic Impact of Point-of-Care CD4 Testing in Mozambique and Other Resource-Limited Settings: A Cost-Effectiveness Analysis
Point-of-care CD4 tests at HIV diagnosis could improve linkage to care in resource-limited settings. Our objective is to evaluate the clinical and economic impact of point-of-care CD4 tests compared to laboratory-based tests in Mozambique.
We use a validated model of HIV testing, linkage, and treatment (CEPAC-International) to examine two strategies of immunological staging in Mozambique: (1) laboratory-based CD4 testing (LAB-CD4) and (2) point-of-care CD4 testing (POC-CD4). Model outcomes include 5-y survival, life expectancy, lifetime costs, and incremental cost-effectiveness ratios (ICERs). Input parameters include linkage to care (LAB-CD4, 34%; POC-CD4, 61%), probability of correctly detecting antiretroviral therapy (ART) eligibility (sensitivity: LAB-CD4, 100%; POC-CD4, 90%) or ART ineligibility (specificity: LAB-CD4, 100%; POC-CD4, 85%), and test cost (LAB-CD4, US$10; POC-CD4, US$24). In sensitivity analyses, we vary POC-CD4-specific parameters, as well as cohort and setting parameters to reflect a range of scenarios in sub-Saharan Africa. We consider ICERs less than three times the per capita gross domestic product in Mozambique (US$570) to be cost-effective, and ICERs less than one times the per capita gross domestic product in Mozambique to be very cost-effective. Projected 5-y survival in HIV-infected persons with LAB-CD4 is 60.9% (95% CI, 60.9%-61.0%), increasing to 65.0% (95% CI, 64.9%-65.1%) with POC-CD4. Discounted life expectancy and per person lifetime costs with LAB-CD4 are 9.6 y (95% CI, 9.6-9.6 y) and US$2,440 (95% CI, US$2,440-US$2,450) and increase with POC-CD4 to 10.3 y (95% CI, 10.3-10.3 y) and US$2,800 (95% CI, US$2,790-US$2,800); the ICER of POC-CD4 compared to LAB-CD4 is US$500/year of life saved (YLS) (95% CI, US$480-US$520/YLS). POC-CD4 improves clinical outcomes and remains near the very cost-effective threshold in sensitivity analyses, even if point-of-care CD4 tests have lower sensitivity/specificity and higher cost than published values. In other resource-limited settings with fewer opportunities to access care, POC-CD4 has a greater impact on clinical outcomes and remains cost-effective compared to LAB-CD4. Limitations of the analysis include the uncertainty around input parameters, which is examined in sensitivity analyses. The potential added benefits due to decreased transmission are excluded; their inclusion would likely further increase the value of POC-CD4 compared to LAB-CD4.
POC-CD4 at the time of HIV diagnosis could improve survival and be cost-effective compared to LAB-CD4 in Mozambique, if it improves linkage to care. POC-CD4 could have the greatest impact on mortality in settings where resources for HIV testing and linkage are most limited. Please see later in the article for the Editors' Summary.
Journal Article