Temporal Trends and Determinants of HIV Testing at Antenatal Care in Sub-Saharan Africa: A Pooled Analysis of Population-Based Surveys (2005-2021).

BACKGROUND: In sub-Saharan Africa (SSA), integrating HIV testing into antenatal care (ANC) has been crucial toward reducing mother-to-child transmission of HIV. With the introduction of new testing modalities, we explored temporal trends in HIV testing within and outside of ANC and identified sociodemographic determinants of testing during ANC. METHODS: We analyzed data from 139 nationally representative household surveys conducted between 2005 and 2021, including more than 2.2 million women aged 15-49 years in 41 SSA countries. We extracted data on women's recent HIV testing history (<24 months), by modality (ie, at ANC versus outside of ANC) and sociodemographic variables (ie, age, socioeconomic status, education level, number of births, urban/rural). We used Bayesian generalized linear mixed models to estimate HIV testing coverage and the proportion of those that tested as part of ANC. RESULTS: HIV testing coverage (<24 months) increased substantially between 2005 and 2021 from 8% to 38%, with significant variations between countries and subregions. Two percent of women received an HIV test in the 24 months preceding the survey interview as part of ANC in 2005 and 11% in 2021. Among women who received an HIV test in the 24 months preceding the survey, the probability of testing at ANC was significantly greater for multiparous, adolescent girls, rural women, women in the poorest wealth quintile, and women in West and Central Africa. CONCLUSION: ANC testing remains an important component to achieving high levels of HIV testing coverage and benefits otherwise underserved women, which could prove instrumental to progress toward universal knowledge of HIV status in SSA.

A small area model to assess temporal trends and sub-national disparities in healthcare quality.

Monitoring subnational healthcare quality is important for identifying and addressing geographic inequities. Yet, health facility surveys are rarely powered to support the generation of estimates at more local levels. With this study, we propose an analytical approach for estimating both temporal and subnational patterns of healthcare quality indicators from health facility survey data. This method uses random effects to account for differences between survey instruments; space-time processes to leverage correlations in space and time; and covariates to incorporate auxiliary information. We applied this method for three countries in which at least four health facility surveys had been conducted since 1999 - Kenya, Senegal, and Tanzania - and estimated measures of sick-child care quality per WHO Service Availability and Readiness Assessment (SARA) guidelines at programmatic subnational level, between 1999 and 2020. Model performance metrics indicated good out-of-sample predictive validity, illustrating the potential utility of geospatial statistical models for health facility data. This method offers a way to jointly estimate indicators of healthcare quality over space and time, which could then provide insights to decision-makers and health service program managers.

Short-Term Effects of the COVID-19 Pandemic on HIV Care Utilization, Service Delivery, and Continuity of HIV Antiretroviral Treatment (ART) in Haiti.

INTRODUCTION: Our study describes changes in HIV care service delivery and continuity of HIV antiretroviral therapy (ART) for people living with HIV (PLHIV) during the 8 weeks before and after diagnosis of the first coronavirus disease 2019 (COVID-19) cases in Haiti on March 19, 2020. METHODS: Using data from 96 out of 167 health facilities offering ART services, we compared four ART program indicators: (1) count of HIV visits; (2) proportion of ART dispenses in community-based settings (DAC); (3) proportion of multi-month dispensing of ART medications > 6 months (> 6 m MMD); and (4) proportion of timely ART refills. We used uncontrolled interrupted time series (ITS) models to estimate slope and level changes in each indicator with the arrival of COVID-19. RESULTS AND DISCUSSION: From week 1 to week 16, the average number of HIV visits fell from 121.5 to 92.5 visits, the proportion of DAC rose from 22.7% to 36.7%, the proportion of > 6 m MMD rose from 29.4% to 48.4%, and the proportion of timely ART refills fell from 51.9% to 43.8%. The ITS models estimated abrupt increases of 36% in > 6 m MMD (p < 0.001) and 37% in DAC (p < 0.001) at the time of COVID-19 arrival, and no change after arrival of COVID-19. The was an abrupt decline of 18% in timely ART refills with the arrival of COVID-19 and a decline of 1% per week thereafter, both non-statistically significant changes. CONCLUSIONS: The sudden changes in HIV service utilization represent dramatic adaptations needed to mitigate primary and secondary effects of the COVID-19 pandemic on PLHIV. This study underscores the urgency of optimizing ART delivery models in Haiti and beyond, in order to maintain progress toward HIV epidemic control.

Closing the gap in implementation of HIV clinical guidelines in a low resource setting using electronic medical records.

BACKGROUND: Universal health coverage promises equity in access to and quality of health services. However, there is variability in the quality of the care (QoC) delivered at health facilities in low and middle-income countries (LMICs). Detecting gaps in implementation of clinical guidelines is key to prioritizing the efforts to improve quality of care. The aim of this study was to present statistical methods that maximize the use of existing electronic medical records (EMR) to monitor compliance with evidence-based care guidelines in LMICs. METHODS: We used iSanté, Haiti's largest EMR to assess adherence to treatment guidelines and retention on treatment of HIV patients across Haitian HIV care facilities. We selected three processes of care - (1) implementation of a 'test and start' approach to antiretroviral therapy (ART), (2) implementation of HIV viral load testing, and (3) uptake of multi-month scripting for ART, and three continuity of care indicators - (4) timely ART pick-up, (5) 6-month ART retention of pregnant women and (6) 6-month ART retention of non-pregnant adults. We estimated these six indicators using a model-based approach to account for their volatility and measurement error. We added a case-mix adjustment for continuity of care indicators to account for the effect of factors other than medical care (biological, socio-economic). We combined the six indicators in a composite measure of appropriate care based on adherence to treatment guidelines. RESULTS: We analyzed data from 65,472 patients seen in 89 health facilities between June 2016 and March 2018. Adoption of treatment guidelines differed greatly between facilities; several facilities displayed 100% compliance failure, suggesting implementation issues. Risk-adjusted continuity of care indicators showed less variability, although several facilities had patient retention rates that deviated significantly from the national average. Based on the composite measure, we identified two facilities with consistently poor performance and two star performers. CONCLUSIONS: Our work demonstrates the potential of EMRs to detect gaps in appropriate care processes, and thereby to guide quality improvement efforts. Closing quality gaps will be pivotal in achieving equitable access to quality care in LMICs.

Image-guided tumour biopsies in a prospective molecular triage study (MOSCATO-01): What are the real risks?

PURPOSE: To evaluate efficacy, complications and preprocedural risk factors for percutaneous image-guided core needle biopsy of malignant tumours for genomic tumour analysis. MATERIALS AND METHODS: Procedural data for core biopsies performed at a single centre for the MOSCATO-01 clinical trial were prospectively recorded between December 2011 and March 2016. Data assessed included patient demographics, tumour characteristics, procedural outcomes and complications. RESULTS: A total of 877 biopsies were performed under computed tomography (38.4%) or ultrasound guidance (61.6%) for tumours in the liver (n = 363), lungs (n = 229), lymph nodes (n = 138), bones (n = 15) and other miscellaneous sites (n = 124). Each biopsy harvested a mean 4.4 samples [1-15], with adequate tumour yield for genomic analysis in 95.3% of cases. Procedural complications occurred in 89 cases (10.1%), with minor grade I complications in 59 (66.3%); grade II in 16 (18%) and grade III in 14 (15.7%). No grade IV complications and no procedure-related death occurred. The most common complications were pneumothorax (51/89, 57.3%), haemorrhage (24/89, 27%) and pain (8/89, 8.9%). Predictive factors for complications by univariate analysis included biopsied organ (lung vs other), sample number, prone position, lesion size, lesion depth and biopsy approach. By multivariate analysis, only pulmonary biopsy was a significant risk factor (odds ratio = 27.23 [4.93-242.76], p < 0.01). CONCLUSION: Percutaneous image-guided core needle biopsy in cancer patients provides an effective method to obtain molecular screening samples, with an overall low complication rate. Lung mass biopsies present a higher risk of complication, although complications are manageable by minimally invasive techniques without prolonged sequelae.

Can we trust the calculation of texture indices of CT images? A phantom study.

PURPOSE: Texture analysis is an emerging tool in the field of medical imaging analysis. However, many issues have been raised in terms of its use in assessing patient images and it is crucial to harmonize and standardize this new imaging measurement tool. This study was designed to evaluate the reliability of texture indices of CT images on a phantom including a reproducibility study, to assess the discriminatory capacity of indices potentially relevant in CT medical images and to determine their redundancy. METHODS: For the reproducibility and discriminatory analysis, eight identical CT acquisitions were performed on a phantom including one homogeneous insert and two close heterogeneous inserts. Texture indices were selected for their high reproducibility and capability of discriminating different textures. For the redundancy analysis, 39 acquisitions of the same phantom were performed using varying acquisition parameters and a correlation matrix was used to explore the 2 × 2 relationships. LIFEx software was used to explore 34 different parameters including first order and texture indices. RESULTS: Only eight indices of 34 exhibited high reproducibility and discriminated textures from each other. Skewness and kurtosis from histogram were independent from the six other indices but were intercorrelated, the other six indices correlated in diverse degrees (entropy, dissimilarity, and contrast of the co-occurrence matrix, contrast of the Neighborhood Gray Level difference matrix, SZE, ZLNU of the Gray-Level Size Zone Matrix). CONCLUSIONS: Care should be taken when using texture analysis as a tool to characterize CT images because changes in quantitation may be primarily due to internal variability rather than from real physio-pathological effects. Some textural indices appear to be sufficiently reliable and capable to discriminate close textures on CT images.

Precision medicine for patients with advanced biliary tract cancers: An effective strategy within the prospective MOSCATO-01 trial.

BACKGROUND: Recommended treatments of patients with advanced biliary tract cancer (aBTC) are limited to one chemotherapy doublet. Nevertheless, efficacy of treatment personalisation for aBTCs is supported by accumulating evidences but remains to be evaluated. PATIENTS AND METHODS: Patients with aBTCs included in the prospective clinical trial MOSCATO-01 were treated by at least one previous systemic treatment, had an ECOG performance status of 0-1, and at least one tumour site accessible to biopsy. Multiple high-throughput molecular analysis was performed on biopsies to drive the administration of molecular targeted agents (MTAs). RESULTS: From November 2011 to March 2016, 43 patients (4%) of the 1035 adult patients included in MOSCATO-01 had aBTCs with a majority of intrahepatic localisation (67%). Successful biopsy procedures and DNA extractions led to molecular portraits for 34 patients (79%). Orientation to an appropriate early clinical trial or accessible MTA(s) was possible for 23 of these patients (68%), and 18 (53%) have received matched MTA(s). Among them, the overall response rate was 33% and the disease control rate was 88%. A PFS ≥6 months was observed in 37% and the PFS ratio was >1.3 for 50% of the patients. These patients had a lower risk for death as compared to the 20 patients not orientated to a matched MTA (HR, 0.29; 95% CI, 0.11-0.76; p = 0.008). CONCLUSIONS: Within the MOSCATO-01 trial, patients with aBTCs had the highest rate of orientation to matched MTAs and derived a clear clinical benefit. A broader evaluation of these findings may improve future treatments strategies for aBTCs. TRIAL REGISTRATION: NCT01566019.

Molecular Screening for Cancer Treatment Optimization (MOSCATO-01) in Pediatric Patients: A Single-Institutional Prospective Molecular Stratification Trial.

Purpose: This single-institutional feasibility study prospectively characterized genomic alterations in recurrent or refractory solid tumors of pediatric patients to select a targeted therapy.Experimental Design: Following treatment failure, patients with signed consent and ages above 6 months, underwent tumor biopsy or surgical resection of primary or metastatic tumor site. These newly acquired samples were analyzed by comparative genomic hybridization array, next-generation sequencing for 75 target genes, whole-exome and RNA sequencing. Biological significance of the alterations and suggestion of most relevant targeted therapies available were discussed in a multidisciplinary tumor board.Results: From December 2012 to January 2016, 75 patients were included, 73 patients underwent 79 interventions, 56 of which were research biopsies with a low complication rate. All patients were pretreated, 37.0% had a brain tumor, and 63.0% had an extra-cranial solid tumor. Median tumor cell content was 70% (range, 0%-100%). Successful molecular analysis in 69 patients detected in 60.9% of patients an actionable alteration in various oncogenic pathways (42.4% with copy-number change, 33.3% with mutation, 2.1% with fusion), and change in diagnosis in three patients. Fourteen patients received 17 targeted therapies; two had received a matched treatment before inclusion.Conclusions: Research biopsies are feasible in advanced pediatric malignancies that exhibit a considerable amount of potentially actionable alterations. Genetic events affecting different cancer hallmarks and limited access to targeted agents within pediatric clinical trials remain the main obstacles that are addressed in our two subsequent precision medicine studies MAPPYACTS and AcSé-ESMART. Clin Cancer Res; 23(20); 6101-12. ©2017 AACR.