Association between Child Tax Credit advance payments and food insufficiency in households experiencing economic shocks.

The COVID-19 pandemic brought increases in economic shocks due to poor health and lost employment, which reduced economic well-being, especially in households with children. The American Rescue Plan Act of 2021 expanded Child Tax Credit (CTC) payments to include eligibility for the lowest income households, boosted benefit levels, and provided monthly advance payments to households with children. Using Census Household Pulse Survey respondent data from January 2021 to July 2022, we evaluated the association between these advance CTC monthly payments and food insufficiency among households with children experiencing health- or employment-related economic shocks (defined as missed work due to COVID-19/other illness or COVID-19-related employer closure/layoff/furlough). Using a triple difference design, we found that the advance CTC was associated with greater reductions in food insufficiency among households with children experiencing economic shocks both compared with households without children and with households with children not experiencing economic shocks. Permanently expanding the advance CTC could create resilience to economic shocks during disease outbreaks, climate disasters, and recessions.

Long-Acting Injectable ART in Practice: A Mixed Methods Implementation Study Assessing the Feasibility of Using LAI ART in High Risk Populations and At Alternative Low Barrier Care Sites.

Long-acting injectable (LAI) antiretroviral therapy (ART) has the potential to change the lives of people living with HIV (PLWH). To ensure equitable access to new treatment modalities, we examined the feasibility and acceptability of administering Cabotegravir Rilpivirine Long Acting (CAB/RPV LA) to individuals who experience challenging social determinants of health (SDoH) and struggle with adherence to traditional oral ART. Quantitative and qualitative data were used to assess feasibility of utilizing ART at alternative clinic. Data were collected on individuals eligible to receive CAB/RPV LA at an alternative street-based clinic and on individuals receiving CAB/RPV LA at a traditional HIV clinic. After 6 months, participants were interviewed about their experience. Providers involved in the implementation were also interviewed about their experiences. Only one participant (out of 5) who received CAB/RPV LA at the alternative clinic received consistent treatment, whereas 17 out of 18 participants receiving CAB/RPV LA at the traditional clinic site were adherent. Participants and providers believed that LAI had potential for making treatment adherence easier, but identified several barriers, including discrepancies between patients' desires and their lifestyles, impact of LAI on interactions with the medical system, risk of resistance accompanying sub-optimal adherence, and need for a very high level of resources. While LAI has major potential benefits for high-risk patients, these benefits must be balanced with the complexities of implementation. Despite challenges that impacted study outcomes, improving treatment outcomes for PLWH requires addressing SDoH and substance use.

Interventions to increase naloxone access for undergraduate students: A systematic review of the literature.

OBJECTIVE: To identify and describe interventions that increase access to naloxone for undergraduate students. METHODS: A systematic review across 4 databases identified interventions that expand access to naloxone at colleges in the United States from 2015-2023. Three reviewers extracted the following data to create a narrative synthesis and summary of program elements: setting, rationale for intervention, timeline, intervention components, study size, collaboration, sustainability, outcomes and results. RESULTS: Seven articles met inclusion criteria. Institutions' implemented naloxone interventions due to concerns for student safety and/or student overdose fatalities. Three universities collaborated with their School of Pharmacy for program design and/or dissemination, while two partnered with state-based naloxone distribution programs. Most programs combined opioid-overdose/naloxone training; four distributed naloxone kits. Three studies included pre/post-outcomes, and all reported increases in participant knowledge, attitudes, and/or ability to respond to an overdose. CONCLUSIONS: Our results indicates an opportunity for wide-scale implementation of undergraduate naloxone programs within US colleges. However, more rigorous implementation research is needed to identify barriers and facilitators to program feasibility, acceptability, and participation.

HIV Prevalence and HIV Screening History Among a Veterans Association Cohort of People with Opioid and Alcohol Use Disorders.

BACKGROUND: Veterans face high risk for HIV and substance use, and thus could be disproportionately impacted by the HIV and substance use disorder (SUD) "syndemic." HIV prevalence among veterans with SUD is unknown. OBJECTIVE: To project HIV prevalence and lifetime HIV screening history among US veterans with alcohol use disorder (AUD), opioid use disorder (OUD), or both. DESIGN: We conducted a retrospective cohort analysis using national Veterans Health Administration (VHA) data. PARTICIPANTS: We selected three cohorts of veterans with SUD: (1) AUD, (2) OUD, and (3) AUD/OUD. Included veterans had ICD codes for AUD/OUD from 2016 to 2022 recorded in VHA electronic medical records, sourced from the VA Corporate Data Warehouse (CDW). MAIN MEASURES: We estimated HIV prevalence by dividing the number of veterans who met two out of three criteria (codes for HIV diagnosis, antiretroviral therapy, or HIV screening/monitoring) by the total number of veterans in each cohort. We also estimated lifetime HIV screening history (as documented in VHA data) by cohort. We reported HIV prevalence and screening history by cohort and across demographic/clinical subgroups. KEY RESULTS: Our sample included 669,595 veterans with AUD, 63,787 with OUD, and 57,015 with AUD/OUD. HIV prevalence was highest in the AUD/OUD cohort (3.9%), followed by the OUD (2.1%) and AUD (1.1%) cohorts. Veterans of Black race and Hispanic/Latinx ethnicity, with HCV diagnoses, and aged 50-64 had the highest HIV prevalence in all cohorts. Overall, 12.8%, 29.1%, and 33.1% of the AUD/OUD, OUD, and AUD cohorts did not have history of HIV screening, respectively. CONCLUSIONS: HIV prevalence was high in all SUD cohorts, and was highest among veterans with AUD/OUD, with disparities by race/ethnicity and age. A substantial portion of veterans had not received HIV screening in the VHA. Findings highlight room for improvement in HIV prevention and screening services for veterans with SUD.

Feasibility and acceptability of a timeline follow-back method to assess opioid use, non-fatal overdose, and substance use disorder treatment.

BACKGROUND: Non-fatal overdoses are underreported and there is no accepted and feasible self-report research measure of non-fatal opioid overdose. Timeline follow-back (TLFB) calendar-based questionnaires assess self-reported risk behaviors. We assessed feasibility and acceptability of a new TLFB research measure for opioid use, non-fatal opioid overdose, and substance use disorder treatment among opioid overdose survivors. METHODS: For the Repeated-dose Behavioral Intervention to Reduce Opioid Overdose Trial (REBOOT) study among opioid overdose survivors, we developed a TLFB questionnaire to assess daily non-prescribed opioid use, opioid overdose, facility stays, medications/behavioral treatment for opioid use disorder, and COVID-19 history during the previous 120 days. Staff assessors administered TLFB at four-monthly visits over the 16-month study participation period. To measure feasibility, we estimated TLFB completion time using an electronic timestamp tool. To measure acceptability, we administered a satisfaction survey to 103 participants who completed REBOOT. RESULTS: Among 525 TLFB assessments conducted in 174 participants from January 2021-January 2023, opioid use was reported in 510 assessments, medication for opioid use disorder (MOUD) in 331 assessments, and ≥ 1 overdose in 107 assessments. Median TLFB completion time was 11 (IQR: 6-17) minutes for sections administered to all participants; detailed overdose questions administered to those reporting overdose took an additional 3 (IQR: 2-6) minutes. Report of ≥ 1 overdose and MOUD use were significantly associated with increased TLFB completion time. 88 % of participants reported that TLFB was very/somewhat acceptable. CONCLUSIONS: Among opioid overdose survivors, REBOOT TLFB was a feasible and acceptable research measure, with similar completion time as other TLFB assessments of substance use.

Out-of-pocket spending and health care utilization associated with initiation of different medications for opioid use disorder: Findings from a national commercially insured cohort.

INTRODUCTION: Buprenorphine and naltrexone are effective medications for opioid use disorder (MOUD). Naltrexone requires complete detoxification from opioids before initiation while buprenorphine does not, which leads to a differential clinical induction challenge. Few studies have evaluated economic costs associated with MOUD initiation. METHODS: We conducted a retrospective cohort analysis using the 2014-2019 Merative MarketScan database. We included individuals diagnosed with opioid use, abuse, or dependence from 2014 to 2019 who initiated one of three MOUD types: 1) buprenorphine, 2) extended-release naltrexone, or 3) oral naltrexone. We calculated total and monthly out-of-pocket spending, for overall and MOUD-specific claims, for the three months prior through three months after MOUD initiation. We also calculated utilization of detoxification, inpatient, and outpatient services monthly over this period. RESULTS: Our cohort included 27,133 individuals; 19,536, 1886, and 5711 initiated buprenorphine, extended-release naltrexone, and oral naltrexone, respectively. Individuals who initiated naltrexone had the highest out-of-pocket spending over the study period. MOUD-specific spending did not contribute substantially to total out-of-pocket spending. Difference in overall spending by MOUD type was driven by a subset of individuals who initiated naltrexone and had very high out-of-pocket spending in the month prior to MOUD initiation. In this month, mean monthly out-of-pocket spending for high-spenders (above 90th percentile within MOUD type category) was $5734 (95 % confidence interval [CI]: $5181-$6286) and $4622 (95 % CI: $4161-$5082) for those who initiated oral and extended-release naltrexone, respectively, compared with $1852 (95 % CI: $1754-$1950) for those who initiated buprenorphine. In the month prior to MOUD initiation, those who initiated naltrexone also had higher detoxification, inpatient, and outpatient episode/visit frequency. In the month prior to initiation, 28.8 % (95 % CI: 27.7 %-30.0 %) and 25.5 % (95 % CI: 23.6 %-27.5 %) of individuals who initiated oral and extended-release naltrexone had detoxification episodes, compared with 9.7 % (95 % CI: 9.3 %-10.1 %) of those who initiated buprenorphine. CONCLUSION: Findings suggest that individuals who initiated naltrexone utilized more intensive health services, including detoxification, in the period prior to MOUD initiation, resulting in significantly higher out-of-pocket spending. Out-of-pocket spending is a patient-centered outcome reflecting potential patient burden. Our results should be considered as part of the shared decision-making process between patients and providers when choosing treatment for OUD.

Increasing the initiation of antiretroviral therapy through optimal placement of diagnostic technologies for pediatric HIV in Zimbabwe: A modeling analysis.

OBJECTIVES: Point-of-care (POC) devices for infant HIV testing provide timely result-return and increase antiretroviral (ART) initiation. We aimed to optimally locate POC devices to increase 30-day ART initiation in Matabeleland South, Zimbabwe. METHODS: We developed an optimization model to identify the locations for limited POC devices at health facilities, maximizing the number of infants who receive HIV test results and initiate ART within 30 days of testing. We compared location-optimization model results to non-model-based decision heuristics, which are more practical and less data-intensive. Heuristics assign POC devices based on demand, test positivity, laboratory result-return probability, and POC machine functionality. RESULTS: With the current placement of 11 existing POC machines, 37% of all tested infants with HIV were projected to receive results and 35% were projected to initiate ART within 30 days of testing. With optimal placement of existing machines, 46% were projected to receive results and 44% to initiate ART within 30 days, retaining three machines in current locations, moving eight to new facilities. Relocation based on the highest POC device functionality would be the best-performing heuristic decision (44% receiving results and 42% initiating ART withing 30 days); although, it still would not perform as well as the optimization-based approach. CONCLUSION: Optimal and ad hoc heuristic relocation of limited POC machines would increase timely result-return and ART initiation, without further, often costly, interventions. Location optimization can enhance decision-making regarding the placement of medical technologies for HIV care.

Cost-effectiveness of point-of-care versus centralised, laboratory-based nucleic acid testing for diagnosis of HIV in infants: a systematic review of modelling studies.

BACKGROUND: Point-of-care (POC) nucleic acid testing for diagnosis of HIV in infants facilitates earlier initiation of antiretroviral therapy (ART) than with centralised (standard-of-care, SOC) testing, but can be more expensive. We evaluated cost-effectiveness data from mathematical models comparing POC with SOC to provide global policy guidance. METHODS: In this systematic review of modelling studies, we searched PubMed, MEDLINE, Embase, the National Health Service Economic Evaluation Database, Econlit, and conference abstracts, combining terms for "HIV" + "infant"/"early infant diagnosis" + "point-of-care" + "cost-effectiveness" + "mathematical models", without restrictions from database inception to July 15, 2022. We selected reports of mathematical cost-effectiveness models comparing POC with SOC for HIV diagnosis in infants younger than 18 months. Titles and abstracts were independently reviewed, with full-text review for qualifying articles. We extracted data on health and economic outcomes and incremental cost-effectiveness ratios (ICERs) for narrative synthesis. The primary outcomes of interest were ICERs (comparing POC with SOC) for ART initiation and survival of children living with HIV. FINDINGS: Our search identified 75 records through database search. 13 duplicates were excluded, leaving 62 non-duplicate articles. 57 records were excluded and five were reviewed in full text. One article was excluded as it was not a modelling study, and four qualifying studies were included in the review. These four reports were from two mathematical models from two independent modelling groups. Two reports used the Johns Hopkins model to compare POC with SOC for repeat early infant diagnosis testing in the first 6 months in sub-Saharan Africa (first report, simulation of 25 000 children) and Zambia (second report, simulation of 7500 children). In the base scenario, POC versus SOC increased probability of ART initiation within 60 days of testing from 19% to 82% (ICER per additional ART initiation range US$430-1097; 9-month cost horizon) in the first report; and from 28% to 81% in the second ($23-1609, 5-year cost horizon). Two reports compared POC with SOC for testing at 6 weeks in Zimbabwe using the Cost-Effectiveness of Preventing AIDS Complications-Paediatric model (simulation of 30 million children; lifetime horizon). POC increased life expectancy and was considered cost-effective compared with SOC (ICER $711-850 per year of life saved in HIV-exposed children). Results were robust throughout sensitivity and scenario analyses. In most scenarios, platform cost-sharing (co-use with other programmes) resulted in POC being cost-saving compared with SOC. INTERPRETATION: Four reports from two different models suggest that POC is a cost-effective and potentially cost-saving strategy for upscaling of early infant testing compared with SOC. FUNDING: Bill & Melinda Gates Foundation, Unitaid, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, WHO, and Massachusetts General Hospital Research Scholars.

Prevalence of undiagnosed HIV among children in South Africa, Côte d'Ivoire and Zimbabwe: a model-based analysis to inform paediatric HIV screening programmes.

INTRODUCTION: To improve the diagnosis and survival of children living with HIV (CLWH), the World Health Organization recommends testing approaches beyond traditional infant HIV testing programmes. Information about undiagnosed HIV prevalence among children of varying ages in the general population is needed to guide innovative national/subnational case-finding and testing approaches. METHODS: We used the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model to estimate the prevalence of undiagnosed HIV in 2-, 5- and 10-year-old children in South Africa, Côte d'Ivoire and Zimbabwe in 2018. We simulated cohorts of children born in 2008 (10-year-olds), 2013 (5-year-olds) and 2016 (2-year-olds). Country-/year-specific inputs for pregnant/breastfeeding women included: HIV prevalence (4.2-32.3%), HIV incidence (0.03-0.24%/month), knowledge of HIV status (27-89%) and antiretroviral drug coverage (36-95%). Paediatric inputs included early infant testing coverage (6-95%) and breastfeeding duration (0-20 months). We projected the proportion of surviving CLWH in whom HIV remained undiagnosed and the undiagnosed HIV prevalence among surviving children of each age in the general population. For children born in 2016, we projected survival and diagnosis of all CLWH through 2026. We conducted sensitivity analyses on model parameters. RESULTS: In 2018, the projected proportion of surviving CLWH whose HIV remained undiagnosed in South Africa/Côte d'Ivoire/Zimbabwe was 44.2%/55.8%/52.9% among 2-year-old CLWH; 29.0%/37.8%/33.2% among 5-year-old CLWH; and 18.3%/25.4%/23.1% among 10-year-old CLWH. Projected general population undiagnosed HIV prevalence in South Africa/Côte d'Ivoire/Zimbabwe was 0.44%/0.32%/0.68% among 2-year-olds; 0.25%/0.17%/0.41% among 5-year-olds; and 0.24%/0.14%/0.38% among 10-year-olds. Among all CLWH born in 2016, 50-54% were projected to die without HIV diagnosis (and subsequently without treatment) within 10 years after birth; 80-85% of these deaths occurred in the first 2 years. CONCLUSIONS: Projected population-level undiagnosed HIV prevalence is low and sharply decreases after age 2, with more CLWH dying than being diagnosed. Despite low undiagnosed prevalence in the general population of older children, we project that a large proportion of CLWH remain undiagnosed, suggesting that innovative strategies targeting untested children of all ages outside of health facility settings should be prioritized. Programmes could consider routine testing of the general population of children below 2 in all settings and children of all ages in high-prevalence settings.

Association of the Expiration of Child Tax Credit Advance Payments With Food Insufficiency in US Households.

Importance: Advance Child Tax Credit (CTC) monthly payments administered to more than 35 million households with children in the US between July and December 2021 were associated with a substantial decrease in food insufficiency. These monthly payments expired in January 2022 after Congress failed to extend the policy, and the subsequent impact on food insufficiency is currently unknown. Objective: To assess whether the expiration of monthly CTC payments in January 2022 was associated with changes in food insufficiency in US households with children. Design, Setting, and Participants: This study used repeated cross-sectional, nationally representative data from multiple waves of the Household Pulse Survey, conducted by the US Census Bureau. Online data collection occurred from July 21, 2021, to July 11, 2022, and data analysis was performed in July 2022. Exposures: The first missed advance CTC payment on January 15, 2022. Main Outcomes and Measures: The main outcome was unadjusted prevalence of household food insufficiency. Event study specification was used to estimate the association between the expiration of the CTC payments and household food insufficiency with the exposure of being in a household with children present. Results: The sample (592 044 respondents, representing households with and without children, for a weighted population size of 123 350 770 individuals) was majority female (362 286 individuals [51.3%]) and non-Hispanic White (425 497 individuals [62.2%]), and a plurality of respondents (248 828 [48.3%]) were aged 25 to 44 years at the time of the survey. During the survey wave just before CTC expiration (reference wave, December 29, 2021, to January 10, 2022), unadjusted household food insufficiency was 12.7% among households with children. In late January and early February 2022, following the first missed CTC monthly payment, 13.6% of households with children reported food insufficiency, increasing to 16.0% by late June and early July 2022. The event study specification estimated a 3.2 percentage point increase (95% CI, 1.4-5.0 percentage points; P < .001) in food insufficiency by the most recent wave available after the first missed CTC payment (June 29 to July 11, 2022) among households with children compared with the reference wave, a 25% increase. Conclusions and Relevance: The findings of this study suggest that there was an increase in food insufficiency among households with children after they stopped receiving monthly CTC payments. Given the well-documented associations between inability to afford food and poor health outcomes across the life span, Congress should consider swift action to reinstate this policy.

Evaluation of four chemotherapy regimens for treatment of advanced AIDS-associated Kaposi sarcoma in Kenya: a cost-effectiveness analysis.

BACKGROUND: The most effective treatment for advanced AIDS-associated Kaposi sarcoma is paclitaxel or pegylated liposomal doxorubicin (PLD); neither is routinely used in sub-Saharan Africa due to limited availability and high cost. We examined the clinical impact, costs, and cost-effectiveness of paclitaxel or PLD in Kenya, compared with etoposide or bleomycin-vincristine. METHODS: In this study, we use the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-International Model to project clinical outcomes and costs among people living with HIV and advanced Kaposi sarcoma on antiretroviral therapy. We compared four different treatment strategies: etoposide, bleomycin-vincristine, paclitaxel, or PLD. We derived cohort characteristics and costs from the Kenyan Academic Model for Providing Access to Healthcare network, and adverse events, efficacy, and mortality from clinical trials. We projected model outcomes over a lifetime and included life expectancy, per-person lifetime costs, and incremental cost-effectiveness ratios (ICERs). We conducted budget impact analysis for 5-year total costs and did deterministic and probabilistic sensitivity analyses to evaluate the effect of uncertainty in input parameters. FINDINGS: We found that paclitaxel would be more effective than bleomycin-vincristine and would increase life expectancy by 4·2 years per person. PLD would further increase life expectancy by 0·6 years per person. Paclitaxel would be the most cost-effective strategy (ICER US$380 per year-of-life-saved compared with bleomycin-vincristine) and would remain cost-effective across a range of scenarios. PLD would be cost-effective compared with paclitaxel if its price were reduced to $100 per cycle (base case $180 per cycle). Implementing paclitaxel instead of bleomycin-vincristine would save approximately 6400 life-years and would increase the overall 5-year Kenyan health-care costs by $3·7 million; increased costs would be primarily related to ongoing HIV care given improved survival. INTERPRETATION: Paclitaxel would substantially increase life expectancy and be cost-effective compared with bleomycin-vincristine for advanced AIDS-associated Kaposi sarcoma in Kenya and should be the standard of care. PLD would further improve survival and be cost-effective with a 44% price reduction. FUNDING: US National Institutes of Health and Massachusetts General Hospital. TRANSLATION: For the Swahili translation of the abstract see Supplementary Materials section.

Cost-effectiveness of Routine Provider-Initiated Testing and Counseling for Children With Undiagnosed HIV in South Africa.

BACKGROUND: We compared the cost-effectiveness of pediatric provider-initiated HIV testing and counseling (PITC) vs no PITC in a range of clinical care settings in South Africa. METHODS: We used the Cost-Effectiveness of Preventing AIDS Complications Pediatric model to simulate a cohort of children, aged 2-10 years, presenting for care in 4 settings (outpatient, malnutrition, inpatient, tuberculosis clinic) with varying prevalence of undiagnosed HIV (1.0%, 15.0%, 17.5%, 50.0%, respectively). We compared "PITC" (routine testing offered to all patients; 97% acceptance and 71% linkage to care after HIV diagnosis) with no PITC. Model outcomes included life expectancy, lifetime costs, and incremental cost-effectiveness ratios (ICERs) from the health care system perspective and the proportion of children with HIV (CWH) diagnosed, on antiretroviral therapy (ART), and virally suppressed. We assumed a threshold of $3200/year of life saved (YLS) to determine cost-effectiveness. Sensitivity analyses varied the age distribution of children seeking care and costs for PITC, HIV care, and ART. RESULTS: PITC improved the proportion of CWH diagnosed (45.2% to 83.2%), on ART (40.8% to 80.4%), and virally suppressed (32.6% to 63.7%) at 1 year in all settings. PITC increased life expectancy by 0.1-0.7 years for children seeking care (including those with and without HIV). In all settings, the ICER of PITC vs no PITC was very similar, ranging from $710 to $1240/YLS. PITC remained cost-effective unless undiagnosed HIV prevalence was <0.2%. CONCLUSIONS: Routine testing improves HIV clinical outcomes and is cost-effective in South Africa if the prevalence of undiagnosed HIV among children exceeds 0.2%. These findings support current recommendations for PITC in outpatient, inpatient, tuberculosis, and malnutrition clinical settings.

Do not forget the children: a model-based analysis on the potential impact of COVID-19-associated interruptions in paediatric HIV prevention and care.

INTRODUCTION: The COVID-19 pandemic has affected women and children globally, disrupting antiretroviral therapy (ART) services and exacerbating pre-existing barriers to care for both pregnant women and paediatric populations. METHODS: We used the Spectrum modelling package and the CEPAC-Pediatric model to project the impact of COVID-19-associated care disruptions on three key populations in the 21 Global Plan priority countries in sub-Saharan Africa: (1) pregnant and breastfeeding women living with HIV and their children, (2) all children (aged 0-14 years) living with HIV (CLWH), regardless of their engagement in care and (3) CLWH who were engaged in care and on ART prior to the start of the pandemic. We projected clinical outcomes over the 12-month period of 1 March 2020 to 1 March 2021. RESULTS: Compared to a scenario with no care disruption, in a 3-month lockdown with complete service disruption, followed by 3 additional months of partial (50%) service disruption, a projected 755,400 women would have received PMTCT care (a 21% decrease), 187,800 new paediatric HIV infections would have occurred (a 77% increase) and 516,800 children would have received ART (a 35% decrease). For children on ART as of March 2020, we projected 507,200 would have experienced ART failure (an 80% increase). Additionally, a projected 88,400 AIDS-related deaths would have occurred (a 27% increase) between March 2020 and March 2021, with 51,700 of those deaths occurring among children engaged in care as of March 2020 (a 54% increase). CONCLUSIONS: While efforts will continue to curb morbidity and mortality stemming directly from COVID-19 itself, it is critical that providers also consider the immediate and indirect harms of this pandemic, particularly among vulnerable populations. Well-informed, timely action is critical to meet the health needs of pregnant women and children if the global community is to maintain momentum towards an AIDS-free generation.

Insurance coverage and financing landscape for HIV treatment and prevention in the USA.

In 2010, the US health insurance system underwent one of its most substantial transformations with the passage of the Affordable Care Act, which increased coverage for millions of people in the USA, including those with and at risk of HIV. Even so, the system of HIV care and prevention services in the USA is a complex patchwork of payers, providers, and financing mechanisms. People with HIV are primarily covered by Medicaid, Medicare, private insurance, or a combination of these; many get care through other programmes, particularly the Ryan White HIV/AIDS Program, which serves as the nation's safety net for people with HIV who remain uninsured or underinsured but offers modest to no support for prevention services. While uninsurance has drastically declined over the past decade, the USA trails other high-income countries in key HIV-specific metrics, including rates of viral suppression. In this paper in the Series, we provide an overview of the coverage and financing landscape for HIV treatment and prevention in the USA, discuss how the Affordable Care Act has changed the domestic health-care system, examine the major programmes that provide coverage and services, and identify remaining challenges.

Cost-effectiveness of a Novel Lipoarabinomannan Test for Tuberculosis in Patients With Human Immunodeficiency Virus.

BACKGROUND: A novel urine lipoarabinomannan assay (FujiLAM) has higher sensitivity and higher cost than the first-generation AlereLAM assay. We evaluated the cost-effectiveness of FujiLAM for tuberculosis testing among hospitalized people with human immunodeficiency virus (HIV), irrespective of symptoms. METHODS: We used a microsimulation model to project clinical and economic outcomes of 3 testing strategies: (1) sputum Xpert MTB/RIF (Xpert), (2) sputum Xpert plus urine AlereLAM (Xpert+AlereLAM), (3) sputum Xpert plus urine FujiLAM (Xpert+FujiLAM). The modeled cohort matched that of a 2-country clinical trial. We applied diagnostic yields from a retrospective study (yields for Xpert/Xpert+AlereLAM/Xpert+FujiLAM among those with CD4 <200 cells/µL: 33%/62%/70%; among those with CD4 ≥200 cells/µL: 33%/35%/47%). Costs of Xpert/AlereLAM/FujiLAM were US$15/3/6 (South Africa) and $25/3/6 (Malawi). Xpert+FujiLAM was considered cost-effective if its incremental cost-effectiveness ratio (US$/year-of-life saved) was <$940 (South Africa) and <$750 (Malawi). We varied key parameters in sensitivity analysis and performed a budget impact analysis of implementing FujiLAM countrywide. RESULTS: Compared with Xpert+AlereLAM, Xpert+FujiLAM increased life expectancy by 0.2 years for those tested in South Africa and Malawi. Xpert+FujiLAM was cost-effective in both countries. Xpert+FujiLAM for all patients remained cost-effective compared with sequential testing and CD4-stratified testing strategies. FujiLAM use added 3.5% (South Africa) and 4.7% (Malawi) to 5-year healthcare costs of tested patients, primarily reflecting ongoing HIV treatment costs among survivors. CONCLUSIONS: FujiLAM with Xpert for tuberculosis testing in hospitalized people with HIV is likely to increase life expectancy and be cost-effective at the currently anticipated price in South Africa and Malawi. Additional studies should evaluate FujiLAM in clinical practice settings.

Strengthening Existing Laboratory-Based Systems vs. Investing in Point-of-Care Assays for Early Infant Diagnosis of HIV: A Model-Based Cost-Effectiveness Analysis.

BACKGROUND: To improve early infant HIV diagnosis (EID) programs, options include replacing laboratory-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and result return. SETTING: We used the CEPAC-Pediatric model to examine clinical benefits and costs of 3 EID strategies in Zimbabwe for infants 6 weeks of age. METHODS: We examined (1) laboratory-based EID (LAB), (2) strengthened laboratory-based EID (S-LAB), and (3) POC EID (POC). LAB/S-LAB and POC assays differed in sensitivity (LAB/S-LAB 100%, POC 96.9%) and specificity (LAB/S-LAB 99.6%, POC 99.9%). LAB/S-LAB/POC algorithms also differed in: probability of result return (79%/91%/98%), time until result return (61/53/1 days), probability of initiating antiretroviral therapy (ART) after positive result (52%/71%/86%), and total cost/test ($18.10/$30.47/$30.71). We projected life expectancy (LE) and average lifetime per-person cost for all HIV-exposed infants. We calculated incremental cost-effectiveness ratios (ICERs) from discounted (3%/year) LE and costs in $/year-of-life saved (YLS), defining cost effective as an ICER <$580/YLS (reflecting programs providing 2 vs. 1 ART regimens). In sensitivity analyses, we varied differences between S-LAB and POC in result return probability, result return time, ART initiation probability, and cost. RESULTS: For infants who acquired HIV, LAB/S-LAB/POC led to projected one-year survival of 67.3%/69.9%/75.6% and undiscounted LE of 21.74/22.71/24.49 years. For all HIV-exposed infants, undiscounted LE was 63.35/63.38/63.43 years, at discounted lifetime costs of $200/220/240 per infant. In cost-effectiveness analysis, S-LAB was an inefficient use of resources; the ICER of POC vs. LAB was $830/YLS. CONCLUSIONS: Current EID programs will attain greater benefit from investing in POC EID rather than strengthening laboratory-based systems.

Estimating the Cost of Point-of-Care Early Infant Diagnosis in a Program Setting: A Case Study Using Abbott m-PIMA and Cepheid GeneXpert IV in Zimbabwe.

BACKGROUND: Point-of-care early infant diagnosis (POC EID) increases access to HIV test results and shortens time to result-return and antiretroviral therapy initiation, as compared to central laboratory-based EID. However, to scale-up POC EID, governments need more information about programmatic costs. METHODS: We evaluated POC EID costs from a health systems perspective. Our primary analysis assessed the Abbott m-PIMA and 2 versions of the Cepheid GeneXpert IV platforms-with a solar battery or gel battery-used in Zimbabwe, with instrument purchase. We also included the following 2 scenarios with zero upfront equipment purchase: (1) m-PIMA using a reagent rental model, with an all-inclusive price when the buyer commits to an average testing volume, and (2) GeneXpert IV, reflecting contexts where GeneXpert is already in place for tuberculosis diagnosis or HIV viral load monitoring. We collected data from project expenditures, observations of health workers, and from government salary scales. We calculated cost per EID test based on number of EID tests performed on each machine per day. RESULTS: The cost per successfully completed test was $44.55 for m-PIMA with platform purchase and $25.89 for m-PIMA reagent rental. Costs for GeneXpert IV with platform purchase were $25.70 using a solar battery, $25.29 using a gel battery, and $23.85 under a scenario assuming no equipment costs. In our primary analyses, materials costs comprised 73%-74% total costs, equipment 14%-20%, labor 5%-8%, training 1%, facility upgrades 1%, and monitoring 1%. CONCLUSIONS: As countries consider scaling up POC EID, these data are important for budgeting and planning.

Front-Line Human Resource Time-Use for Early Infant HIV Diagnosis: A Comparative Time-Motion Study at Centralized and Point-of-Care Health Facilities in Zimbabwe.

BACKGROUND: Point-of-care (POC) assays for early infant diagnosis of HIV (EID) increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy when compared with laboratory-based assays. However, there is a significant gap in our understanding of its human resource impact at the facility level. This study evaluates front-line health workers' (HWs') time associated with EID. SETTING: Using time-motion methodology, we collected time-use data on EID tasks performed by HWs at 3 EID facility types in Zimbabwe-5 POC hubs, 9 POC spokes, and 11 facilities that used centralized laboratories. METHODS: Data collectors observed 30 EID processes and 30 HWs' provided self-reported time. Comparisons of mean differences of HWs' time-use between centralized and POC EID were performed with a 2-sample t test with unequal variances. RESULTS: Observed average total labor time per EID test at POC facilities was 28 minutes, 22 seconds [95% confidence interval (CI): 22:51 to 35:48], which was equivalent to the average preresult time at facilities using centralized EID. HWs performed other tasks while the machine processed samples. Observed average preresult time (counseling to sample preparation) was 18 minutes, 6 Supported by seconds (95% CI: 13:00 to 23:42) for POC compared with 27 minutes, 48 seconds (95% CI: 23:48 to 32:50) for facilities using centralized laboratories. The mean difference of 9 minutes, 42 seconds (95% CI: 03:04 to 16:18) was statistically significant. The differences in self-reported average total labor time per EID test between HWs at facilities using centralized laboratories or POC were not statistically significant. CONCLUSION: Use of POC assays did not incur additional human resource time compared with sending dried blood spots to a centralized laboratory for EID.

Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis.

Background: Tenofovir alafenamide-emtricitabine (F/TAF) was recently approved as a noninferior and potentially safer option than tenofovir disoproxil fumarate-emtricitabine (F/TDF) for HIV preexposure prophylaxis (PrEP) in the United States. Objective: To estimate the greatest possible clinical benefits and economic savings attributable to the improved safety profile of F/TAF and the maximum price payers should be willing to pay for F/TAF over generic F/TDF. Design: Cost-effectiveness analysis. Data Sources: Published literature on F/TDF safety (in persons with and those without HIV) and the cost and quality-of-life effects of fractures and end-stage renal disease (ESRD). Target Population: Age-stratified U.S. men who have sex with men (MSM) using PrEP. Time Horizon: Five years. Perspective: Health care sector. Intervention: Preexposure prophylaxis with F/TAF versus F/TDF. Outcome Measures: Fractures averted, cases of ESRD averted, quality-adjusted life-years (QALYs) saved, costs, incremental cost-effectiveness ratios (ICERs), and maximum justifiable price for F/TAF compared with generic F/TDF. Results of Base-Case Analysis: Over a 5-year horizon, compared with F/TDF, F/TAF averted 2101 fractures and 25 cases of ESRD for the 123 610 MSM receiving PrEP, with an ICER of more than $7 million per QALY. At a 50% discount for generic F/TDF ($8300 per year) and a societal willingness to pay up to $100 000 per QALY, the maximum fair price for F/TAF was $8670 per year. Results of Sensitivity Analysis: Among persons older than 55 years, the ICER for F/TAF remained more than $3 million per QALY and the maximum permissible fair price for F/TAF was $8970 per year. Results were robust to alternative time horizons and PrEP-using population sizes. Limitation: Intermittent use and on-demand PrEP were not considered. Conclusion: In the presence of a generic F/TDF alternative, the improved safety of F/TAF is worth no more than an additional $370 per person per year. Primary Funding Source: National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and Massachusetts General Hospital Executive Committee on Research.