The Systems Analysis and Improvement Approach: specifying core components of an implementation strategy to optimize care cascades in public health.

BACKGROUND: Healthcare systems in low-resource settings need simple, low-cost interventions to improve services and address gaps in care. Though routine data provide opportunities to guide these efforts, frontline providers are rarely engaged in analyzing them for facility-level decision making. The Systems Analysis and Improvement Approach (SAIA) is an evidence-based, multi-component implementation strategy that engages providers in use of facility-level data to promote systems-level thinking and quality improvement (QI) efforts within multi-step care cascades. SAIA was originally developed to address HIV care in resource-limited settings but has since been adapted to a variety of clinical care systems including cervical cancer screening, mental health treatment, and hypertension management, among others; and across a variety of settings in sub-Saharan Africa and the USA. We aimed to extend the growing body of SAIA research by defining the core elements of SAIA using established specification approaches and thus improve reproducibility, guide future adaptations, and lay the groundwork to define its mechanisms of action. METHODS: Specification of the SAIA strategy was undertaken over 12 months by an expert panel of SAIA-researchers, implementing agents and stakeholders using a three-round, modified nominal group technique approach to match core SAIA components to the Expert Recommendations for Implementing Change (ERIC) list of distinct implementation strategies. Core implementation strategies were then specified according to Proctor's recommendations for specifying and reporting, followed by synthesis of data on related implementation outcomes linked to the SAIA strategy across projects. RESULTS: Based on this review and clarification of the operational definitions of the components of the SAIA, the four components of SAIA were mapped to 13 ERIC strategies. SAIA strategy meetings encompassed external facilitation, organization of provider implementation meetings, and provision of ongoing consultation. Cascade analysis mapped to three ERIC strategies: facilitating relay of clinical data to providers, use of audit and feedback of routine data with healthcare teams, and modeling and simulation of change. Process mapping matched to local needs assessment, local consensus discussions and assessment of readiness and identification of barriers and facilitators. Finally, continuous quality improvement encompassed tailoring strategies, developing a formal implementation blueprint, cyclical tests of change, and purposefully re-examining the implementation process. CONCLUSIONS: Specifying the components of SAIA provides improved conceptual clarity to enhance reproducibility for other researchers and practitioners interested in applying the SAIA across novel settings.

Transition to independent care for youth living with HIV: a cluster randomised clinical trial.

BACKGROUND: Transitioning youth living with HIV to adult care is a crucial step in the HIV care continuum; however, tools to support transition in sub-Saharan Africa are insufficient. We assessed the effectiveness of an adolescent transition package (ATP) to improve youth readiness for transition to independent HIV care. METHODS: In this hybrid type 1, multicentre, cluster randomised clinical trial, we assessed the effectiveness of an ATP (administered by routine clinic staff, which included standardised assessments and chapter books to guide discussions at scheduled clinic visits) in four counties in Kenya, with HIV clinics randomly assigned 1:1 to ATP or control (standard-of-care practice). Clinics were eligible to participate if they had at least 50 youth (aged 10-24 years) living with HIV enrolled in care. We used restricted randomisation to achieve cluster balance and an independent biostatistician used computer-generated random numbers to assign clinics. We excluded very large clinics with more than 1000 youth, clinics with fewer than 50 youth, paediatric-only clinics, clinics with logistical challenges, and the smallest clinics in Homa Bay county. Youth were eligible for the transition intervention if they were enrolled in participating clinics, were aged 15-24 years, and were aware of their positive HIV diagnosis. Study staff assessed transition readiness scores overall and by four domains (HIV literacy, self-management, communication, and support) in youth with HIV, which were then compared between groups by use of mixed-effects linear regression models. Analysis was by intention-to-treat and was adjusted for multiple comparisons. This trial is registered with ClinicalTrials.gov, NCT03574129. FINDINGS: We identified 35 clinics in four counties; of these, ten were assigned to the intervention group and ten to the control group. Of 1066 youth with HIV enrolled between Nov 1, 2019, and March 18, 2020, 578 (54%) were in intervention and 488 (46%) in control sites. Mean baseline transition readiness score was 12·1 (SD 3·4) in ATP sites and 11·4 (3·7) in control sites. At 1 year, adjusting for baseline scores, age, and months since HIV disclosure, participants in the ATP group had significantly higher overall transition readiness scores (adjusted mean difference 1·7, 95% CI 0·3-3·1, p=0·024), and higher scores in HIV literacy domain (adjusted mean difference 1·0, 0·2-1·7, p=0·011). At 12 months, 15 serious adverse events were recorded, none of which were thought to be related to study participation. INTERPRETATION: Integrating ATP approaches could enhance long-term HIV care in youth with HIV as they age into adulthood. FUNDING: US National Institutes of Health.

Brief Report: Performance of Tuberculosis Symptom Screening Among Hospitalized ART-Naive Children With HIV in Kenya.

BACKGROUND: The World Health Organization (WHO) recommends tuberculosis (TB) diagnostic evaluation for children with HIV (CHIV) who have history of TB contact, poor weight gain, cough, or fever. These screening criteria were developed based on studies of symptomatic CHIV with incomplete microbiologic confirmation. We performed routine TB microbiologic evaluation of hospitalized CHIV with and without symptoms to develop a data-driven TB symptom screen. METHODS: Among hospitalized antiretroviral therapy-naive Kenyan CHIV enrolled in the Pediatric Urgent Start of Highly Active Antiretroviral Therapy (PUSH) trial, we performed Xpert MTB/RIF and mycobacterial culture of respiratory and stool specimens independent of TB symptoms. We evaluated performance of WHO and other published pediatric TB screening criteria and derived optimized criteria using a combination of symptoms. RESULTS: Of 168 CHIV who underwent TB microbiologic evaluation, 13 (8%) had confirmed TB. WHO TB symptom screening had 100% sensitivity and 4% specificity to detect confirmed TB. Published TB screening criteria that relied on prolonged symptoms missed cases of confirmed TB (sensitivity 85%-92%). An optimized symptom screen including weight loss, cough, anorexia, or TB contact had 100% sensitivity and improved specificity (31%) compared with the WHO pediatric TB symptom screen. CONCLUSIONS: The WHO TB symptom screen was highly sensitive but resulted in a high proportion of hospitalized CHIV who would require TB diagnostic evaluation. Other published TB screening criteria missed CHIV with confirmed TB. Our optimized screening tool increased specificity while preserving sensitivity. Future multicenter studies are needed to improve TB screening tools for CHIV in both inpatient and outpatient settings.

Cascade Analysis: An Adaptable Implementation Strategy Across HIV and Non-HIV Delivery Platforms.

BACKGROUND: Cascades have been used to characterize sequential steps within a complex health system and are used in diverse disease areas and across prevention, testing, and treatment. Routine data have great potential to inform prioritization within a system, but are often inaccessible to frontline health care workers (HCWs) who may have the greatest opportunity to innovate health system improvement. METHODS: The cascade analysis tool (CAT) is an Excel-based, simple simulation model with an optimization function. It identifies the step within a cascade that could most improve the system. The original CAT was developed for HIV treatment and the prevention of mother-to-child transmission of HIV. RESULTS: CAT has been adapted 7 times: to a mobile application for prevention of mother-to-child transmission; for hypertension screening and management and for mental health outpatient services in Mozambique; for pediatric and adolescent HIV testing and treatment, HIV testing in family planning, and cervical cancer screening and treatment in Kenya; and for naloxone distribution and opioid overdose reversal in the United States. The main domains of adaptation have been technical-estimating denominators and structuring steps to be binary sequential steps-as well as logistical-identifying acceptable approaches for data abstraction and aggregation, and not overburdening HCW. DISCUSSION: CAT allows for prompt feedback to HCWs, increases HCW autonomy, and allows managers to allocate resources and time in an equitable manner. CAT is an effective, feasible, and acceptable implementation strategy to prioritize areas most requiring improvement within complex health systems, although adaptations are being currently evaluated.

Financial Incentives to Increase Uptake of Pediatric HIV Testing (FIT): study protocol for a randomised controlled trial in Kenya.

INTRODUCTION: Index case testing (ICT) to identify HIV-infected children is efficient but has suboptimal uptake. Financial incentives (FI) have overcome financial barriers in other populations by offsetting direct and indirect costs. A pilot study found FI to be feasible for motivating paediatric ICT among HIV-infected female caregivers. This randomised trial will determine the effectiveness of FI to increase uptake of paediatric ICT. METHODS AND ANALYSIS: The Financial Incentives to Increase Uptake of Pediatric HIV Testing trial is a five-arm, unblinded, randomised controlled trial that determines whether FI increases timely uptake of paediatric ICT. The trial will be conducted in multiple public health facilities in western Kenya. Each HIV-infected adult enrolled in HIV care will be screened for eligibility: primary caregiver to one or more children of unknown HIV status aged 0-12 years. Eligible caregivers will be individually randomised at the time of recruitment in equal 1:1:1:1:1 allocation to one of five arms (US$0 (control), US$1.25, US$2.50, US$5.00 and US$10.00). The trial aims to randomise 800 caregivers. Incentives will be disbursed at the time of child HIV testing using mobile money transfer or cash. Arms will be compared in terms of the proportion of adults who complete testing for at least one child within 2 months of randomisation and time to testing. A cost-effectiveness analysis of FI for paediatric ICT will also be conducted. ETHICS AND DISSEMINATION: This study was reviewed and approved by the University of Washington Institutional Review Board and the Kenyatta National Hospital Ethics and Research Committee. Trial results will be disseminated to healthcare workers at study sites, regional and national policymakers, and with patient populations at study sites (regardless of enrolment in the trial). Randomised trials of caregiver-child FI interventions pose unique study design, ethical and operational challenges, detailed here as a resource for future investigations. TRIAL REGISTRATION NUMBER: NCT03049917; Pre-results.

Financial Incentives for Pediatric HIV Testing in Kenya.

The acceptability of financial incentives for pediatric HIV testing was evaluated in Kenya. Sixty HIV-positive women with children of unknown status were randomized to receive $5, $10 or $15 conditional upon HIV testing. Forty-four (73%) completed child testing, with similar rates across arms. Uptake was significantly higher than a cohort with similar procedures but no incentives (73% vs. 14%, P < 0.001).

Implementation and Operational Research: Active Referral of Children of HIV-Positive Adults Reveals High Prevalence of Undiagnosed HIV.

OBJECTIVES: Few routine systems exist to test older, asymptomatic children for HIV. Testing all children in the population has high uptake but is inefficient, whereas testing only symptomatic children increases efficiency but misses opportunities to optimize outcomes. Testing children of HIV-infected adults in care may efficiently identify previously undiagnosed HIV-infected children before symptomatic disease. METHODS: HIV-infected parents in HIV care in Nairobi, Kenya were systematically asked about their children's HIV status and testing history. Adults with untested children ≤12 years old were actively referred and offered the choice of pediatric HIV testing at home or clinic. Testing uptake and HIV prevalence were determined, as were bottlenecks in pediatric HIV testing cascade. RESULTS: Of 10,426 HIV-infected adults interviewed, 8,287 reported having children, of whom 3,477 (42%) had children of unknown HIV status, and 611 (7%) had children ≤12 years of unknown HIV status. After implementation of active referral, the rate of pediatric HIV testing increased 3.8-fold from 3.5 to 13.6 children tested per month (Relative risk: 3.8, 95% confidence interval: 2.3 to 6.1). Of 611 eligible adults, 279 (48%) accepted referral and were screened, and 74 (14%) adults completed testing of 1 or more children. HIV prevalence among 108 tested children was 7.4% (95% confidence interval: 3.3 to 14.1%) and median age was 8 years (interquartile range: 2-11); 1 child was symptomatic at testing. CONCLUSIONS: Referring HIV-infected parents in care to have their children tested revealed many untested children and significantly increased the rate of pediatric testing; prevalence of HIV was high. However, despite increases in pediatric testing, most adults did not complete testing of their children.

Hospitalized Children Reveal Health Systems Gaps in the Mother-Child HIV Care Cascade in Kenya.

To identify missed opportunities in HIV prevention, diagnosis, and linkage to care, we enrolled 183 hospitalized, HIV-infected, ART-naïve Kenyan children 0-12 years from four hospitals in Nairobi and Kisumu, and reviewed prevention of mother-to-child transmission of HIV (PMTCT), hospitalization, and HIV testing history. Median age was 1.8 years (IQR = 0.8, 4.5). Most mothers received HIV testing during pregnancy (77%). Among mothers tested, 60% and 40% reported HIV-negative and positive results, respectively; 33% of HIV-diagnosed mothers did not receive PMTCT antiretrovirals. First missed opportunities for pediatric diagnosis and linkage were due to failure to test mothers (23.1%), maternal HIV acquisition following initial negative test (45.7%), no early infant diagnosis (EID) or provider-initiated testing (PITC) (12.7%), late breastfeeding transmission (8.7%), failure to collect child HIV test results (1.2%), and no linkage to care following HIV diagnosis (8.7%). Among previously hospitalized children, 38% never received an HIV test. Strengthening initial and repeat maternal HIV testing and PITC are key interventions to prevent, detect, and treat pediatric HIV infections.