Cost-Effectiveness and Budget Impact Analysis of the Implementation of Differentiated Service Delivery Models for HIV Treatment in Mozambique: a Modelling Study.

INTRODUCTION: In 2018, the Mozambique Ministry of Health launched guidelines for implementing differentiated service delivery models (DSDMs) to optimize HIV service delivery, improve retention in care, and ultimately reduce HIV-associated mortality. The models were fast-track, 3-month antiretrovirals dispensing, community antiretroviral therapy groups, adherence clubs, family approach and three one-stop shop models: adolescent-friendly health services, maternal and child health, and tuberculosis. We conducted a cost-effectiveness analysis and budget impact analysis to compare these models to conventional services. METHODS: We constructed a decision tree model based on the percentage of enrolment in each model and the probability of the outcome (12-month retention in treatment) for each year of the study period-three for the cost-effectiveness analysis (2019-2021) and three for the budget impact analysis (2022-2024). Costs for these analyses were primarily estimated per client-year from the health system perspective. A secondary cost-effectiveness analysis was conducted from the societal perspective. Budget impact analysis costs included antiretrovirals, laboratory tests and service provision interactions. Cost-effectiveness analysis additionally included start-up, training and clients' opportunity costs. Effectiveness was estimated using an uncontrolled interrupted time series analysis comparing the outcome before and after the implementation of the differentiated models. A one-way sensitivity analysis was conducted to identify drivers of uncertainty. RESULTS: After implementation of the DSDMs, there was a mean increase of 14.9 percentage points (95% CI: 12.2, 17.8) in 12-month retention, from 47.6% (95% CI, 44.9-50.2) to 62.5% (95% CI, 60.9-64.1). The mean cost difference comparing DSDMs and conventional care was US$ -6 million (173,391,277 vs. 179,461,668) and -32.5 million (394,705,618 vs. 433,232,289) from the health system and the societal perspective, respectively. Therefore, DSDMs dominated conventional care. Results were most sensitive to conventional care interaction costs in the one-way sensitivity analysis. For a population of 1.5 million, the base-case 3-year financial costs associated with the DSDMs was US$550 million, compared with US$564 million for conventional care. CONCLUSIONS: DSDMs were less expensive and more effective in retaining clients 12 months after antiretroviral therapy initiation and were estimated to save approximately US$14 million for the health system from 2022 to 2024.

Scaling-up and scaling-out the Systems Analysis and Improvement Approach to optimize the hypertension diagnosis and care cascade for HIV infected individuals (SCALE SAIA-HTN): a stepped-wedge cluster randomized trial.

BACKGROUND: Undiagnosed and untreated hypertension is a main driver of cardiovascular disease and disproportionately affects persons living with HIV (PLHIV) in low- and middle-income countries. Across sub-Saharan Africa, guideline application to screen and manage hypertension among PLHIV is inconsistent due to poor service readiness, low health worker motivation, and limited integration of hypertension screening and management within HIV care services. In Mozambique, where the adult HIV prevalence is over 13%, an estimated 39% of adults have hypertension. As the only scaled chronic care service in the county, the HIV treatment platform presents an opportunity to standardize and scale hypertension care services. Low-cost, multi-component systems-level strategies such as the Systems Analysis and Improvement Approach (SAIA) have been found effective at integrating hypertension and HIV services to improve the effectiveness of hypertension care delivery for PLHIV, reduce drop-offs in care, and improve service quality. To build off lessons learned from a recently completed cluster randomized trial (SAIA-HTN) and establish a robust evidence base on the effectiveness of SAIA at scale, we evaluated a scaled-delivery model of SAIA (SCALE SAIA-HTN) using existing district health management structures to facilitate SAIA across six districts of Maputo Province, Mozambique. METHODS: This study employs a stepped-wedge design with randomization at the district level. The SAIA strategy will be "scaled up" with delivery by district health supervisors (rather than research staff) and will be "scaled out" via expansion to Southern Mozambique, to 18 facilities across six districts in Maputo Province. SCALE SAIA-HTN will be introduced over three, 9-month waves of intensive intervention, where technical support will be provided to facilities and district managers by study team members from the Mozambican National Institute of Health. Our evaluation of SCALE SAIA-HTN will be guided by the RE-AIM framework and will seek to estimate the budget impact from the payer's perspective. DISCUSSION: SAIA packages user-friendly systems engineering tools to support decision-making by frontline health workers and to identify low-cost, contextually relevant improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial will determine an effective strategy for national scale-up and inform program planning. TRIAL REGISTRATION: ClinicalTrials.gov NCT05002322 (registered 02/15/2023).

Impact of differentiated service delivery models on 12-month retention in HIV treatment in Mozambique: an interrupted time-series analysis.

BACKGROUND: HIV treatment has been available in Mozambique since 2004, but coverage of, and retention in, antiretroviral therapy (ART) remain suboptimal. Therefore, to increase health system efficiency and reduce HIV-associated mortality, in November, 2018, the Ministry of Health launched national guidelines on implementing eight differentiated service delivery models (DSDMs) for HIV treatment. We assessed the effect of this implementation on retention in ART 12 months after initiation, and explored the associated effects of COVID-19. METHODS: In this uncontrolled interrupted time-series analysis, data were extracted from the Mozambique ART database, which contains data on individuals in ART care from 1455 health facilities providing ART in Mozambique. We included individual-level data from facilities that were providing ART at the beginning of the study period (Jan 1, 2016) and at the start of DSDM implementation (Dec 1, 2018). We compared the proportion of individuals retained in ART 12 months after initiation between the periods before (Jan 1, 2017, to Nov 30, 2018) and after (Dec 1, 2019, to June 30, 2021) implementation of the DSDMs, overall and stratified by sex and age. We applied a generalised estimating equation model with a working independence correlation and cluster-robust standard errors to account for clustering at the facility level. In a secondary analysis, we assessed the effect of COVID-19 response measures during the post-intervention period on ART retention. FINDINGS: The study included 613 facilities and 1 131 118 individuals who started ART during the inclusion period up to June 30, 2020, of whom 79 178 (7·0%) were children (age ≤14 years), 226 224 (20·0%) were adolescents and young adults (age 15-24 years), and 825 716 (73·0%) were adults (age ≥25 years). 731 623 (64·7%) were female and 399 495 (35·3%) were male. Introduction of the DSDMs was associated with an estimated increase of 24·5 percentage points (95% CI 21·1 to 28·0) in 12-month ART retention by the end of the study period, compared with the counterfactual scenario without DSDM implementation. By age, the smallest effect was estimated in children (6·1 percentage points, 1·3 to 10·9) and the largest effect in adolescents and young adults (28·8 percentage points, 24·2 to 33·4); by sex, a larger effect was estimated in males (29·7 percentage points, 25·6 to 33·7). Our analysis showed that COVID-19 had an overall negative effect on 12-month retention in ART compared with a counterfactual scenario based on the post-intervention period without COVID-19 (-10·0 percentage points, -18·2 to -1·8). INTERPRETATION: The implementation of eight DSDMs for HIV treatment had a positive impact on 12-month retention in ART. COVID-19 negatively influenced this outcome. FUNDING: None. TRANSLATION: For the Portuguese translation of the abstract see Supplementary Materials section.

Managers' and providers' perspectives on barriers and facilitators for the implementation of differentiated service delivery models for HIV treatment in Mozambique: a qualitative study.

INTRODUCTION: In 2018, Mozambique's Ministry of Health launched a guideline for a nationwide implementation of eight differentiated service delivery models to optimize HIV service delivery and achieve universal coverage of HIV care and treatment. The models were (1) Fast-track, (2) Three-month Antiretrovirals Dispensing, (3) Community Antiretroviral Therapy Groups, (4) Adherence Clubs, (5) Family-approach, and three one-stop shop models for (6) Tuberculosis, (7) Maternal and Child Health, and (8) Adolescent-friendly Health Services. This study identified drivers of implementation success and failure across these differentiated service delivery models. METHODS: Twenty in-depth individual interviews were conducted with managers and providers from the Ministry of Health and implementing partners from all levels of the health system between July and September 2021. National-level participants were based in the capital city of Maputo, and participants at provincial, district and health facility levels were from Sofala province, a purposively selected setting. The Consolidated Framework for Implementation Research (CFIR) guided data collection and thematic analysis. Deductively selected constructs were assessed while allowing for additional themes to emerge inductively. RESULTS: The CFIR constructs of Relative Advantage, Complexity, Patient Needs and Resources, and Reflecting and Evaluating were identified as drivers of implementation, whereas Available Resources and Access to Knowledge and Information were identified as barriers. Fast-track and Three-month Antiretrovirals Dispensing models were deemed easier to implement and more effective in reducing workload. Adherence Clubs and Community Antiretroviral Therapy Groups were believed to be less preferred by clients in urban settings. COVID-19 (an inductive theme) improved acceptance and uptake of individual differentiated service delivery models that reduced client visits, but it temporarily interrupted the implementation of group models. CONCLUSIONS: This study described important determinants to be addressed or leveraged for the successful implementation of differentiated service delivery models in Mozambique. The models were considered advantageous overall for the health system and clients when compared with the standard of care. However, successful implementation requires resources and ongoing training for frontline providers. COVID-19 expedited individual models by loosening the inclusion criteria; this experience can be leveraged to optimize the design and implementation of differentiated service delivery models in Mozambique and other countries.

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.

Correction to: Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): a hybrid type III cluster randomized trial.

Following publication of the original article [1], the authors reported a typo in the title of the article.

Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): a hybrid type III cluster randomized trial.

BACKGROUND: Across sub-Saharan Africa, evidence-based clinical guidelines to screen and manage hypertension exist; however, country level application is low due to lack of service readiness, uneven health worker motivation, weak accountability of health worker performance, and poor integration of hypertension screening and management with chronic care services. The systems analysis and improvement approach (SAIA) is an evidence-based implementation strategy that combines systems engineering tools into a five-step, facility-level package to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). As hypertension screening and management are integrated into chronic care services in sub-Saharan Africa, an opportunity exists to test whether SAIA interventions shown to be effective in improving efficiency and coverage of HIV services can be effective when applied to the non-communicable disease services that leverage the same platform. We hypothesize that SAIA-hypertension (SAIA-HTN) will be effective as an adaptable, scalable model for broad implementation. METHODS: We will deploy a hybrid type III cluster randomized trial to evaluate the impact of SAIA-HTN on hypertension management in eight intervention and eight control facilities in central Mozambique. Effectiveness outcomes include hypertension cascade flow measures (screening, diagnosis, management, control), as well as hypertension and HIV clinical outcomes among people living with HIV. Cost-effectiveness will be estimated as the incremental costs per additional patient passing through the hypertension cascade steps and the cost per additional disability-adjusted life year averted, from the payer perspective (Ministry of Health). SAIA-HTN implementation fidelity will be measured, and the Consolidated Framework for Implementation Research will guide qualitative evaluation of the implementation process in high- and low-performing facilities to identify determinants of intervention success and failure, and define core and adaptable components of the SAIA-HTN intervention. The Organizational Readiness for Implementing Change scale will measure facility-level readiness for adopting SAIA-HTN. DISCUSSION: SAIA packages user-friendly systems engineering tools to guide decision-making by front-line health workers to identify low-cost, contextually appropriate chronic care improvement strategies. By integrating SAIA into routine hypertension screening and management structures, this pragmatic trial is designed to test a model for national scale-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT04088656 (registered 09/13/2019; https://clinicaltrials.gov/ct2/show/NCT04088656).