- Browse by Author
Browsing by Author "Carlucci, James G."
Now showing 1 - 10 of 10
Results Per Page
Sort Options
Item Addressing Pediatric HIV Pretreatment Drug Resistance and Virologic Failure in Sub-Saharan Africa: A Cost-Effectiveness Analysis of Diagnostic-Based Strategies in Children ≥3 Years Old(MDPI, 2021-03-21) Siriruchatanon, Mutita; Liu, Shan; Carlucci, James G.; Enns, Eva A.; Duarte, Horacio A.; Pediatrics, School of MedicineImprovement of antiretroviral therapy (ART) regimen switching practices and implementation of pretreatment drug resistance (PDR) testing are two potential approaches to improve health outcomes for children living with HIV. We developed a microsimulation model of disease progression and treatment focused on children with perinatally acquired HIV in sub-Saharan Africa who initiate ART at 3 years of age. We evaluated the cost-effectiveness of diagnostic-based strategies (improved switching and PDR testing), over a 10-year time horizon, in settings without and with pediatric dolutegravir (DTG) availability as first-line ART. The improved switching strategy increases the probability of switching to second-line ART when virologic failure is diagnosed through viral load testing. The PDR testing strategy involves a one-time PDR test prior to ART initiation to guide choice of initial regimen. When DTG is not available, PDR testing is dominated by the improved switching strategy, which has an incremental cost-effectiveness ratio (ICER) of USD 579/life-year gained (LY), relative to the status quo. If DTG is available, improved switching has a similar ICER (USD 591/LY) relative to the DTGstatus quo. Even when substantial financial investment is needed to achieve improved regimen switching practices, the improved switching strategy still has the potential to be cost-effective in a wide range of sub-Saharan African countries. Our analysis highlights the importance of strengthening existing laboratory monitoring systems to improve the health of children living with HIV.Item Clinical and programmatic outcomes of HIV-exposed infants enrolled in care at geographically diverse clinics, 1997-2021: A cohort study(Public Library of Science, 2022-09-15) Edmonds, Andrew; Brazier, Ellen; Musick, Beverly S.; Yotebieng, Marcel; Humphrey, John; Abuogi, Lisa L.; Adedimeji, Adebola; Keiser, Olivia; Msukwa, Malango; Carlucci, James G.; Maia, Marcelle; Pinto, Jorge A.; Leroy, Valériane; Davies, Mary-Ann; Wools-Kaloustian, Kara K.; IeDEA; Biostatistics, School of Public HealthBackground: Although 1·3 million women with HIV give birth annually, care and outcomes for HIV-exposed infants remain incompletely understood. We analyzed programmatic and health indicators in a large, multidecade global dataset of linked mother-infant records from clinics and programs associated with the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. Methods and findings: HIV-exposed infants were eligible for this retrospective cohort analysis if enrolled at <18 months at 198 clinics in 10 countries across 5 IeDEA regions: East Africa (EA), Central Africa (CA), West Africa (WA), Southern Africa (SA), and the Caribbean, Central, and South America network (CCASAnet). We estimated cumulative incidences of DNA PCR testing, loss to follow-up (LTFU), HIV diagnosis, and death through 24 months of age using proportional subdistribution hazard models accounting for competing risks. Competing risks were transfer, care withdrawal, and confirmation of negative HIV status, along with LTFU and death, when not the outcome of interest. In CA and EA, we quantified associations between maternal/infant characteristics and each outcome. A total of 82,067 infants (47,300 EA, 10,699 CA, 6,503 WA, 15,770 SA, 1,795 CCASAnet) born from 1997 to 2021 were included. Maternal antiretroviral therapy (ART) use during pregnancy ranged from 65·6% (CCASAnet) to 89·5% (EA), with improvements in all regions over time. Twenty-four-month cumulative incidences varied widely across regions, ranging from 12·3% (95% confidence limit [CL], 11·2%,13·5%) in WA to 94·8% (95% CL, 94·6%,95·1%) in EA for DNA PCR testing; 56·2% (95% CL, 55·2%,57·1%) in EA to 98·5% (95% CL, 98·3%,98·7%) in WA for LTFU; 1·9% (95% CL, 1·6%,2·3%) in WA to 10·3% (95% CL, 9·7%,10·9%) in EA for HIV diagnosis; and 0·5% (95% CL, 0·2%,1·0%) in CCASAnet to 4·7% (95% CL, 4·4%,5·0%) in EA for death. Although infant retention did not improve, HIV diagnosis and death decreased over time, and in EA, the cumulative incidence of HIV diagnosis decreased substantially, declining to 2·9% (95% CL, 1·5%,5·4%) in 2020. Maternal ART was associated with decreased infant mortality (subdistribution hazard ratio [sdHR], 0·65; 95% CL, 0·47,0·91 in EA, and sdHR, 0·51; 95% CL, 0·36,0·74 in CA) and HIV diagnosis (sdHR, 0·40; 95% CL, 0·31,0·50 in EA, and sdHR, 0·41; 95% CL, 0·31,0·54 in CA). Study limitations include potential misclassification of outcomes in real-world service delivery data and possible nonrepresentativeness of IeDEA sites and the population of HIV-exposed infants they serve. Conclusions: While there was marked regional and temporal heterogeneity in clinical and programmatic outcomes, infant LTFU was high across all regions and time periods. Further efforts are needed to keep HIV-exposed infants in care to receive essential services to reduce HIV infection and mortality.Item Clinical Findings and Evaluation of Newborns Who Were Anonymously Surrendered(American Medical Association, 2024-01-02) Liepmann, Claire D.; Nafiseh, Amira A.; Carlucci, James G.; Enane, Leslie A.; Pediatrics, School of MedicineThis cohort study examines clinical findings, medical treatment, and outcomes for infants in Indiana who were surrendered under Safe Haven laws.Item Demographics and trends of cleft lip and palate patients born in Tennessee from 2000 to 2017(Elsevier, 2022-12) Belcher, Ryan H.; Patel, Siddharth A.; Kynes, Matthew; Carlucci, James G.; Hodson, Erin; Zhao, Shilin; Lipscomb, Brittany; Heimburger, Douglas C.; Pediatrics, School of MedicineObjective The goal of this study was to evaluate the prevalence of orofacial clefts (OFCs) in Tennessee over the span of 2000–2017, and evaluate the effects of race/ethnicity, sex, maternal/paternal age and socioeconomic status on the prevalence. Methods Records of all live births and demographics of newborns in Tennessee from 2000 to 2017 were requested from the Tennessee Department of Health to calculate the prevalence of OFCs. Data from United States Census was also obtained. Data provided were deidentified. Results Tennessee showed a significant decrease in prevalence rates of cleft lip, with and without cleft palate (CL ± P), when comparing the time periods of 2000–2007 to 2008–2017. A significant positive correlation was found with CL ± P prevalence rates in regions with higher Caucasian populations and a negative correlation in regions with higher African American populations. The CP prevalence rates showed a negative correlation with increased median household income. Conclusion To our knowledge, this is the first study to show a significant negative correlation with median household income and CP prevalence rates. Our study showing an increase in prevalence rates of OFCs with decreased socioeconomic status indicates that the areas of Tennessee with the lowest median household income averages would likely benefit from understanding other possible modifiable factors that are driving this correlation.Item The effect of a Mentor Mothers program on prevention of vertical transmission of HIV outcomes in Zambézia Province, Mozambique: a retrospective interrupted time series analysis(Wiley, 2022) Carlucci, James G.; Yu, Zhihong; González, Purificación; Bravo, Magdalena; Amorim, Gustavo; das Felicidades Cugara, Cristina; Guambe, Helga; Mucanhenga, Jaime; Silva, Wilson; Tique, José A.; Sardella Alvim, Maria Fernanda; Graves, Erin; De Schacht, Caroline; Wester, C. William; Pediatrics, School of MedicineIntroduction: Mentor Mothers (MM) provide peer support to pregnant and postpartum women living with HIV (PPWH) and their infants with perinatal HIV exposure (IPE) throughout the cascade of prevention of vertical transmission (PVT) services. MM were implemented in Zambézia Province, Mozambique starting in August 2017. This evaluation aimed to determine the effect of MM on PVT outcomes. Methods: A retrospective interrupted time series analysis was done using routinely collected aggregate data from 85 public health facilities providing HIV services in nine districts of Zambézia. All PPWH (and their IPE) who initiated antiretroviral therapy (ART) from August 2016 through April 2019 were included. Outcomes included the proportion per month per district of: PPWH retained in care 12 months after ART initiation, PPWH with viral suppression and IPE with HIV DNA PCR test positivity by 9 months of age. The effect of MM on outcomes was assessed using logistic regression. Results: The odds of 12-month retention increased 1.5% per month in the pre-MM period, compared to a monthly increase of 7.6% with-MM (35-61% pre-MM, 56-72% with-MM; p < 0.001). The odds of being virally suppressed decreased by 0.9% per month in the pre-MM period, compared to a monthly increase of 3.9% with-MM (49-85% pre-MM, 59-80% with-MM; p < 0.001). The odds of DNA PCR positivity by 9 months of age decreased 8.9% per month in the pre-MM period, compared to a monthly decrease of 0.4% with-MM (0-14% pre-MM, 4-10% with-MM; p < 0.001). The odds of DNA PCR uptake (the proportion of IPE who received DNA PCR testing) by 9 months of age were significantly higher in the with-MM period compared to the pre-MM period (48-100% pre-MM, 87-100% with-MM; p < 0.001). Conclusions: MM services were associated with improved retention in PVT services and higher viral suppression rates among PPWH. While there was ongoing but diminishing improvement in DNA PCR positivity rates among IPE following MM implementation, this might be explained by increased uptake of HIV testing among high-risk IPE who were previously not getting tested. Additional efforts are needed to further optimize PVT outcomes, and MM should be one part of a comprehensive strategy to address this critical need.Item Global HIV mortality trends among children on antiretroviral treatment corrected for under‐reported deaths: an updated analysis of the International epidemiology Databases to Evaluate AIDS collaboration(Wiley, 2021-09) Kassanjee, Reshma; Johnson, Leigh F.; Zaniewski, Elizabeth; Ballif, Marie; Christ, Benedikt; Yiannoutsos, Constantin T.; Nyakato, Patience; Desmonde, Sophie; Edmonds, Andrew; Sudjaritruk, Tavitiya; Pinto, Jorge; Vreeman, Rachel; Dahourou, Désiré Lucien; Twizere, Christelle; Kariminia, Azar; Carlucci, James G.; Kasozi, Charles; Davies, Mary-Ann; Biostatistics, School of Public HealthIntroduction: The Joint United Nations Programme on HIV/AIDS (UNAIDS) projections of paediatric HIV prevalence and deaths rely on the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium for mortality estimates among children living with HIV (CHIV) receiving antiretroviral therapy (ART). Previous estimates, based on data through 2014, may no longer be accurate due to expanded paediatric HIV care and treatment eligibility, and the possibility of unreported deaths in CHIV considered lost to follow-up (LTFU). We therefore estimated all-cause mortality and its trends in CHIV (<15 years old) on ART using extended and new IeDEA data. Methods: We analysed (i) IeDEA observational data from CHIV in routine care globally, and (ii) novel data from an IeDEA tracing study that determined outcomes in a sample of CHIV after being LTFU in southern Africa. We included 45,711 CHIV on ART during 2004 to 2017 at 72 programmes in Africa, Asia-Pacific and Latin America. We used mixed effects Poisson regression to estimate mortality by age, sex, CD4 at ART start, time on ART, region and calendar year. For Africa, in an adjusted analysis that accounts for unreported deaths among those LTFU, we first modified the routine data by simulating mortality outcomes within six months after LTFU, based on a Gompertz survival model fitted to the tracing data (n = 221). Results: Observed mortality rates were 1.8 (95% CI: 1.7 to 1.9) and 9.4 (6.3 to 13.4) deaths per 100 person-years in the routine and tracing data, respectively. We found strong evidence of higher mortality at shorter ART durations, lower CD4 values, and in infancy. Averaging over covariate patterns, the adjusted mortality rate was 54% higher than the unadjusted rate. In unadjusted analyses, mortality reduced by an average 60% and 73% from 2005 to 2017, within and outside of Africa, respectively. In the adjusted analysis for Africa, this temporal reduction was 42%. Conclusions: Mortality rates among CHIV have decreased substantially over time. However, when accounting for worse outcomes among those LTFU, mortality estimates increased and temporal improvements were slightly reduced, suggesting caution in interpreting analyses based only on programme data. The improved and updated IeDEA estimates on mortality among CHIV on ART support UNAIDS efforts to accurately model global HIV statistics.Item High Rates of Viral Suppression and Care Retention among Youth Born Outside of the United States with Perinatally Acquired HIV(Wolters Kluwer, 2022-12) Desai, Neerav; Jenkins, Cathy A.; Zanoni, Brian; Nmoh, Ashley; Patel, Nehali; Shepherd, Bryan E.; Hussen, Sophia; Doraivelu, Kamini; Pierce, Leslie; Carlucci, James G.; Ahonkhai, Aima A.; Pediatrics, School of MedicineBackground: Youth born outside of the US with perinatally acquired HIV infection (YBoUS-PHIV) account for most children living with HIV in the US, but there are few data characterizing their care outcomes. Methods: We conducted a retrospective study of YBoUS-PHIV receiving care across 3 HIV clinics in the Southeastern US between October 2018 and 2019. Primary outcomes were retention in care and viral suppression defined as (1) proportion of suppressed viral loads (VLs) and (2) having all VLs suppressed (definition 1 presented in the abstract). Primary predictors were age, adoption and disclosure status (full, partial and none/unknown). Multivariable logistic regression and χ 2 tests were used to test for associations with care outcomes. Analysis of disclosure status was restricted to youth greater than or equal to 12 years. Results: The cohort included 111 YBoUS-PHIV. Median age was 14 years (interquartile range, 12-18), 59% were female, and 79% were international adoptees. Overall, 84% of patients were retained in care, and 88% were virally suppressed at each VL measurement. Adopted youth were more likely to be virally suppressed than nonadopted youth [odds ratio (OR), 7.08; P < 0.01] although the association was not statistically significant in adjusted analysis (adjusted OR, 4.26; P = 0.07). Neither age nor adoption status was significantly associated with retention. Among 89 patients greater than or equal to 12 years, 74% were fully disclosed of their HIV status, 12% were partially disclosed, and 13% had not started the disclosure process. There was no significant difference in retention or viral suppression by disclosure status. Conclusions: YBoUS-PHIV achieved high rates of retention and viral suppression. Adopted youth may be more likely to achieve viral suppression which may reflect the need for tailored interventions for nonadopted youth.Item Predicting neurodevelopmental risk in children born to mothers living with HIV in Kenya: protocol for a prospective cohort study (Tabiri Study)(BMJ, 2022-04-04) Oyungu, Eren; El Kebbi, Ola; Vreeman, Rachel; Nyandiko, Winstone; Monahan, Patrick O.; Tu, Wanzhu; Khaitan, Alka; Desta, Zeruesenay; Slogrove, Amy L.; Humphrey, John M.; Were, Edwin; Patel, Rena C.; Carlucci, James G.; Wools-Kaloustian, Kara; McHenry, Megan S.; Pediatrics, School of MedicineIntroduction: For the growing number of children with in utero and postpartum exposure to HIV and/or antiretrovirals, it is unclear which exposures or risk factors play a significant role in predicting worse neurodevelopmental outcomes. This protocol describes a prospective longitudinal cohort study of infants born to mothers living with HIV and those born to mothers without HIV. We will determine which risk factors are most predictive of child neurodevelopment at 24 months. We aim to create a risk assessment tool to help predict which children are at risk for worse neurodevelopment outcomes. Methods and analysis: This study leverages an existing Kenyan cohort to prospectively enrol 500 children born to mothers living with HIV and 500 to those without HIV (n=1000 total) and follow them from birth to age 24 months. The following factors will be measured every 6 months: infectious morbidity and biological/sociodemographic/psychosocial risk factors. We will compare these factors between the two groups. We will then measure and compare neurodevelopment within children in both groups at 24 months of age using the Child Behaviour Checklist and the Bayley Scales of Infant and Toddler Development, third edition. Finally, we will use generalised linear mixed modelling to quantify associations with neurodevelopment and create a risk assessment tool for children ≤24 months. Ethics and dissemination: The study is approved by the Moi University's Institutional Research and Ethics Committee (IREC/2021/55; Approval #0003892), Kenya's National Commission for Science, Technology and Innovation (NACOSTI, Reference #700244) and Indiana University's Institutional Review Board (IRB Protocol #110990). This study carries minimal risk to the children and their mothers, and all mothers will provide written consent for participation in the study. Results will be disseminated to maternal child health clinics within Uasin Gishu County, Kenya and via papers submitted to peer-reviewed journals and presentation at international conferences.Item Preferences of Pregnant and Postpartum Women for Differentiated Service Delivery in Kenya(Wolters Kluwer, 2023) Humphrey, John; Wanjama, Esther; Carlucci, James G.; Naanyu, Violet; Were, Edwin; Muli, Lindah; Alera, Marsha; McGuire, Alan; Nyandiko, Winstone; Songok, Julia; Wools-Kaloustian, Kara; Zimet, Gregory; Medicine, School of MedicineBackground: Differentiated service delivery models are implemented by HIV care programs globally, but models for pregnant and postpartum women living with HIV (PPWH) are lacking. We conducted a discrete choice experiment to determine women's preferences for differentiated service delivery. Setting: Five public health facilities in western Kenya. Methods: PPWH were enrolled from April to December 2022 and asked to choose between pairs of hypothetical clinics that differed across 5 attributes: clinic visit frequency during pregnancy (monthly vs. every 2 months), postpartum visit frequency (monthly vs. only with routine infant immunizations), seeing a mentor mother (each visit vs. as needed), seeing a clinician (each visit vs. as needed), and basic consultation cost (0, 50, or 100 Kenya Shillings [KSh]). We used multinomial logit modeling to determine the relative effects (β) of each attribute on clinic choice. Results: Among 250 PPWH (median age 31 years, 42% pregnant, 58% postpartum, 20% with a gap in care), preferences were for pregnancy visits every 2 months (β = 0.15), postpartum visits with infant immunizations (β = 0.36), seeing a mentor mother and clinician each visit (β = 0.05 and 0.08, respectively), and 0 KSh cost (β = 0.39). Preferences were similar when stratified by age, pregnancy, and retention status. At the same cost, predicted market choice for a clinic model with fewer pregnant/postpartum visits was 75% versus 25% for the standard of care (ie, monthly visits during pregnancy/postpartum). Conclusion: PPWH prefer fewer clinic visits than currently provided within the standard of care in Kenya, supporting the need for implementation of differentiated service delivery for this population.Item Retention in care and viral suppression in the PMTCT continuum at a large referral facility in western Kenya(Springer, 2022) Humphrey, John M.; Songok, Julia; Ofner, Susan; Musick, Beverly; Alera, Marsha; Kipchumba, Bett; McHenry, Megan S.; Carlucci, James G.; Park, Jun; Mwangi, Winfred; Yiannoutsos, Constantin; Bakoyannis, Giorgos; Wools-Kaloustian, Kara; Medicine, School of MedicineMedical records of pregnant and postpartum women living with HIV and their infants attending a large referral facility in Kenya from 2015 to 2019 were analyzed to identify characteristics associated with retention in care and viral suppression. Women were stratified based on the timing of HIV care enrollment: known HIV-positive (KHP; enrolled pre-pregnancy) and newly HIV-positive (NHP; enrolled during pregnancy). Associations with retention at 18 months postpartum and viral suppression (< 1000 copies/mL) were determined. Among 856 women (20% NHP), retention was 83% for KHPs and 53% for NHPs. Viral suppression was 88% for KHPs and 93% for NHPs, but 19% of women were missing viral load results. In a competing risk model, viral suppression increased by 18% for each additional year of age but was not associated with other factors. Overall, 1.9% of 698 infants with ≥ 1 HIV test result were HIV-positive. Tailored interventions are needed to promote retention and viral load testing, particularly for NHPs, in the PMTCT continuum.