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.

Motivations, barriers, and communication recommendations for promoting face coverings during the COVID-19 pandemic: Survey findings from a diverse sample.

State and local health departments have been tasked with promoting the use of face coverings to decrease the spread of COVID-19 in their respective communities. However, little is known about motivations and barriers to wearing face coverings in the context of COVID-19 prevention, particularly among communities of color who are at an increased risk of serious illness from the disease. The purpose of this study was to identify common motivations and barriers to face covering use, as well as explore perceptions of messages encouraging the use of face coverings among a racially and ethnically diverse sample. A survey was distributed electronically to North Carolina (NC) residents through NC Department of Health and Human Services listservs in July 2020. Participants self-categorized as Latino/a (33.5%), Black (39.1%), or white or another race (27.5%). The most commonly endorsed motivations for wearing face coverings were to avoid spreading COVID-19 (77%), as well as to protect people who are vulnerable (76%) and one's community (72%). Being uncomfortable (40%) was the most commonly endorsed barrier. Messages that included a clear request (ex. please wear a face covering) and a direct benefit (ex. keep community safe) were more commonly endorsed than those that did not. Commonly endorsed motivations, behaviors, and messages differed by race and ethnicity. Increased attention to message content, message structure, and access to information and resources may aid local officials in increasing consistent use of face coverings.

Barriers and Facilitators Faced by Athletic Trainers Implementing National Athletic Trainers' Association Inter-Association Task Force Preseason Heat-Acclimatization Guidelines in US High School Football Players.

CONTEXT: The aim of the National Athletic Trainers' Association Inter-Association Task Force (NATA-IATF) preseason heat-acclimatization guidelines was to acclimatize high school athletes to the environment during the first 2 weeks of the preseason and reduce the risk of exertional heat illness. OBJECTIVE: To identify barriers and facilitators that high school athletic trainers (ATs) encountered when implementing the NATA-IATF guidelines. DESIGN: Qualitative study. SETTING: Individual phone interviews with all participants. PATIENTS OR OTHER PARTICIPANTS: Thirty-three ATs (16 men, 17 women; age = 36.0 ± 12.0 years, athletic training experience = 12.9 ± 10.5 years) representing 19 states (4 with state mandates) were interviewed before data saturation was achieved. Participants were purposefully sampled from a larger investigation based on stratification of US Census region and preidentified high school compliance with the NATA-IATF guidelines. MAIN OUTCOME MEASURE(S): A cross-sectional, semistructured phone interview (6 steps) was conducted with each participant and then transcribed verbatim. A 7-person research team (5 coders, 2 auditors) coded the data into themes and categories, focusing on consensus of data placement to reduce bias and ensure accuracy. RESULTS: Facilitators and barriers that influenced successful guideline implementation were (1) perceived stakeholder access, (2) perceived stakeholder role, (3) capability and capacity, (4) school culture, (5) logistical support, (6) resources, (7) physical environment, and (8) consistency of the guidelines. Overall, participants discussed facilitators and barriers within each category based on their experiences and circumstances. CONCLUSIONS: Athletic trainers faced numerous concerns regarding compliance with the NATA-IATF preseason heat-acclimatization guidelines. Multiple levels of influence should be targeted to improve implementation. These include intrapersonal factors by giving ATs the education and self-efficacy to support advocacy for implementation, interpersonal components by establishing strong collaborative networks for change, community and environmental factors by optimizing school culture and community resources for implementation, and policy aspects by establishing consistent guidelines across all bodies.

Motivations and Barriers for the Use of Face Coverings during the COVID-19 Pandemic: Messaging Insights from Focus Groups.

Widespread use of face coverings is a key public health strategy to prevent the spread of COVID-19. However, few studies have examined why Americans use or do not use face coverings, and little is known about the most effective messaging strategies. This study explored perceptions of face coverings, including motivations and barriers for use, and examined reactions to messaging promoting the use of face coverings. Six virtual focus groups were conducted with 34 North Carolina residents in July 2020. Participants reported high compliance with face covering recommendations but often did not wear them around family, friends, and colleagues. The most prevalent motivation for the use of face coverings was to protect or respect other people, including high-risk populations and individuals. Other motivators were self-protection, responsibility, desire for control, requirements, and expert advice. Barriers included physical and social discomfort, confusion or misinformation, low perceived susceptibility to COVID-19, and perceptions of identity and autonomy. Even among individuals who frequently wear face coverings, there are opportunities to improve compliance. Messaging should highlight how face coverings protect the wearer and others around them, normalize the use of face coverings in social settings, and emphasize requirements. Positive messages that focus on unity, personal experiences and the rationale for face coverings are recommended.

Contraception, HIV Services, and PrEP in South African Hair Salons: A Qualitative Study of Owner, Stylist, and Client Perspectives.

Women experience challenges engaging with the healthcare system, but frequently utilize hair salons; these are promising venues for family planning and HIV prevention services. Our objective was to assess the acceptability of nurse-offered contraceptive and PrEP services at hair salons in Durban, South Africa. We interviewed salon owners (N = 10) and clients (N = 42) and conducted focus groups with hair stylists (N = 43 stylists; 6 focus groups across five hair salons) to explore barriers and facilitators to providing contraception and PrEP in salons. After developing a codebook, we performed content analysis to identify themes within each conceptual area; 10% of transcripts were coded by two coders to ensure reliability. Content was analyzed according to the following categories: (1) facilitators of and (2) barriers to utilizing these services, and (3) factors to consider for program implementation. Participants identified convenience and female-oriented, supportive atmosphere as facilitators to offering HIV and contraceptive services in salons. Owners and stylists noted that establishing legitimacy was important for program success, including providing promotional pamphlets and employing nurses. Clients cited privacy concerns surrounding HIV testing in a public space as a significant barrier to using these services. Overall, participants were enthusiastic about the program. Convenience and a conducive environment were noted as facilitators to receiving health services in the hair salon; attention will have to be directed to establishing privacy and program legitimacy. Hair salons represent an innovative venue for reaching young women at high-risk for unintended pregnancy and HIV infection.

Cost-Effectiveness of Preemptive Switching to Efavirenz-Based Antiretroviral Therapy for Children With Human Immunodeficiency Virus.

BACKGROUND: The NEVEREST-3 (South Africa) and MONOD-ANRS-12206 (Côte d'Ivoire, Burkina Faso) randomized trials found that switching to efavirenz (EFV) in human immunodeficiency virus-infected children >3 years old who were virologically suppressed by ritonavir-boosted lopinavir (LPV/r) was noninferior to continuing o LPV/r. We evaluated the cost-effectiveness of this strategy using the Cost-Effectiveness of Preventing AIDS Complications-Pediatric model. METHODS: We examined 3 strategies in South African children aged ≥3 years who were virologically suppressed by LPV/r: (1) continued LPV/r, even in case of virologic failure, without second-line regimens; continued on LPV/r with second-line option after observed virologic failure; and preemptive switch to EFV-based antiretroviral therapy (ART), with return to LPV/r after observed virologic failure. We derived data on 24-week suppression (<1000 copies/mL) after a switch to EFV (98.4%) and the subsequent risk of virologic failure (LPV/r, 0.23%/mo; EFV, 0.15%/mo) from NEVEREST-3 data; we obtained ART costs (LPV/r, $6-$20/mo; EFV, $3-$6/mo) from published sources. We projected discounted life expectancy (LE) and lifetime costs per person. A secondary analysis used data from MONOD-ANRS-12206 in Côte d'Ivoire. RESULTS: Continued LPV/r led to the shortest LE (18.2 years) and the highest per-person lifetime cost ($19 470). LPV/r with second-line option increased LE (19.9 years) and decreased per-person lifetime costs($16 070). Switching led to the longest LE (20.4 years) and the lowest per-person lifetime cost ($15 240); this strategy was cost saving under plausible variations in key parameters. Using MONOD-ANRS-12206 data in Côte d'Ivoire, the Switch strategy remained cost saving only compared with continued LPV/r, but the LPV/r with second-line option strategy was cost-effective compared with switching. CONCLUSION: For children ≥3 years old and virologically suppressed by LPV/r-based ART, preemptive switching to EFV can improve long-term clinical outcomes and be cost saving. CLINICAL TRIALS REGISTRATION: NCT01127204.

Using national laboratory data to assess cumulative frequency of linkage after transfer to community-based HIV clinics in South Africa.

INTRODUCTION: Changes to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) funding have led to closures of non-governmental HIV clinics with patient transfers to government-funded clinics. We sought to determine the success of transfers in South Africa using a national data source. METHODS: All adults (≥18 years) on antiretroviral therapy (ART) who visited a single PEPFAR-funded hospital-based HIV clinic in Durban, South Africa from March to June 2012 were transferred to community-based clinics. Previously, we matched patient records from the hospital-based HIV clinic with National Health Laboratory Services (NHLS) Corporate Data Warehouse (CDW) data to estimate the proportion of patients with a CD4 count or viral load (VL) in the CDW during the year before transfer. As a proxy for retention in care, in this study we evaluated whether patients had a CD4 count or VL at another facility within approximately three years of transfer. Patients referred to a private doctor at transfer were excluded from the analysis. We assessed predictors (age, sex, CD4 count, VL status, ART duration and location of future care) of not having post-transfer laboratory data using Cox proportional hazards models. RESULTS: Of the 3893 patients referred to a government facility at transfer, 41% were male and median age was 39 years (IQR 34 to 46). There was a post-transfer CD4 count or VL from another facility for 23% of these individuals within six months, 44% within one year, 57% within two years and 61% within approximately three years. Male sex (aHR 1.20, 95% CI 1.10 to 1.31) and shorter duration on ART (<3 months, aHR 3.80, 95% CI 2.77 to 5.21; three months to one year, aHR 1.32, 95% CI 1.15 to 1.51, each compared with >1 year) were associated with not having a post-transfer record. CONCLUSIONS: Using data from the NHLS CDW, 61% of patients had evidence of a post-transfer laboratory record at another facility within approximately three years after closure of a large South African HIV clinic. Males and those with shorter time on ART prior to transfer were at highest risk for lacking follow-up laboratory data. As patients transfer care, national data sources can be used to evaluate long-term patient care trajectories.

Clinical effect and cost-effectiveness of incorporation of point-of-care assays into early infant HIV diagnosis programmes in Zimbabwe: a modelling study.

BACKGROUND: New point-of-care (POC) assays for early infant HIV diagnosis are costlier than conventional total nucleic acid assays, but could increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy. We aimed to assess the clinical benefits and cost-effectiveness of incorporating these POC assays into early infant diagnosis programmes in Zimbabwe. METHODS: We used the Cost Effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model to examine the clinical benefits, costs, and cost-effectiveness of replacing conventional assays for early infant HIV diagnosis with POC assays at age 6 weeks in Zimbabwe. We simulated two strategies for early infant HIV diagnosis: conventional and POC. Modelled assays differed in sensitivity; specificity; time to, and probability of, return of results; and cost. Model outcomes included survival, life expectancy, and mean lifetime per-person treatment cost, which were reported separately for all HIV-exposed infants and all infants with HIV. We calculated incremental cost-effectiveness ratios with discounted (3% per year) costs and life expectancy from a health-care system perspective for all HIV-exposed infants. We judged incremental cost-effectiveness ratios of $1010 (Zimbabwe's annual gross domestic product per person) or less per year of life saved to be cost-effective. FINDINGS: When conventional assays were used for early infant diagnosis, projected undiscounted life expectancy was 22·7 years for infants with HIV and 62·5 years for all HIV-exposed infants, at a cost of $610 per HIV-exposed infant. Use of POC assays for early infant HIV diagnosis improved projected undiscounted life expectancy to 25·5 years among infants with HIV and 62·6 years among HIV-exposed infants at a cost of $690 per HIV-exposed infant. At age 12 weeks, survival among all infants with HIV was 76·1% with the conventional testing strategy and 83·5% with the POC testing strategy. The incremental cost-effectiveness ratio of POC assays versus conventional assays for early infant diagnosis was $680 per year of life saved. When conventional assay characteristics remained constant, this ratio remained under the cost-effectiveness threshold as long as the specificity and sensitivity of the POC assay were greater than 92% and 65%, respectively. Our results were robust to plausible variations in POC assay cost, the probability of ART initiation, and probability of return of the results of POC testing. INTERPRETATION: Compared with conventional assays, POC assays for early infant HIV diagnosis in Zimbabwe will improve survival, extend life expectancy, and be cost-effective for HIV-exposed infants. FUNDING: Elizabeth Glaser Pediatric AIDS Foundation, US National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Unitaid.

Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa.

BACKGROUND: Community-based GeneXpert MTB/RIF testing may increase detection of prevalent TB in the community and improve rates of TB treatment completion. METHODS: We conducted a pilot randomized trial to evaluate the impact of GeneXpert screening on a mobile HIV testing unit. Adults (≥18y) underwent rapid HIV testing and TB symptom screening and were randomized to usual mobile unit care (providing sputum on the mobile unit sent out for GeneXpert testing) or the "Test & Treat TB" intervention with immediate GeneXpert testing. Symptomatic participants in usual care produced sputum that was sent for hospital-based GeneXpert testing; participants were contacted ~ 7 days later with results. In the "Test & Treat TB" intervention, HIV-infected or HIV-uninfected/TB symptomatic participants underwent GeneXpert testing on the mobile unit. GeneXpert+ participants received expedited TB treatment initiation, monthly SMS reminders and non-cash incentives. We assessed 6-month TB treatment outcomes. RESULTS: 4815 were eligible and enrolled; median age was 27 years (IQR 22 to 35). TB symptoms included cough (5%), weight loss (4%), night sweats (4%), and fever (3%). 42% of eligible participants produced sputum (intervention: 56%; usual care: 26%). Seven participants tested GeneXpert+, six in the intervention (3%, 95% CI 1%, 5%) and one in usual care (1%, 95% CI 0%, 6%). 5 of 6 intervention participants completed TB treatment; the GeneXpert+ participant in usual care did not. CONCLUSION: GeneXpert MTB/RIF screening on a mobile HIV testing unit is feasible. Yield for GeneXpert+ TB was low, however, the "Test & Treat TB" strategy led to high rates of TB treatment completion. TRIAL REGISTRATION: This study was registered on November 21, 2014 at ClinicalTrials.gov ( NCT02298309 ).