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).

A sequential, multiple assignment randomized trial comparing web-based education to mobile video interpreter access for improving provider interpreter use in primary care clinics: the mVOCAL hybrid type 3 study protocol.

BACKGROUND: Individuals who use a language other than English for medical care are at risk for disparities related to healthcare safety, patient-centered care, and quality. Professional interpreter use decreases these disparities but remains underutilized, despite widespread access and legal mandates. In this study, we compare two discrete implementation strategies for improving interpreter use: (1) enhanced education targeting intrapersonal barriers to use delivered in a scalable format (interactive web-based educational modules) and (2) a strategy targeting system barriers to use in which mobile video interpreting is enabled on providers' own mobile devices. METHODS: We will conduct a type 3 hybrid implementation-effectiveness study in 3-5 primary care organizations, using a sequential multiple assignment randomized trial (SMART) design. Our primary implementation outcome is interpreter use, calculated by matching clinic visits to interpreter invoices. Our secondary effectiveness outcome is patient comprehension, determined by comparing patient-reported to provider-documented visit diagnosis. Enrolled providers (n = 55) will be randomized to mobile video interpreting or educational modules, plus standard interpreter access. After 9 months, providers with high interpreter use will continue as assigned; those with lower use will be randomized to continue as before or add the alternative strategy. After another 9 months, both strategies will be available to enrolled providers for 9 more months. Providers will complete 2 surveys (beginning and end) and 3 in-depth interviews (beginning, middle, and end) to understand barriers to interpreter use, based on the Theoretical Domains Framework. Patients who use a language other than English will be surveyed (n = 648) and interviewed (n = 75) following visits with enrolled providers to understand their experiences with communication. Visits will be video recorded (n = 100) to assess fidelity to assigned strategies. We will explore strategy mechanism activation to refine causal pathway models using a quantitative plus qualitative approach. We will also determine the incremental cost-effectiveness of each implementation strategy from a healthcare organization perspective, using administrative and provider survey data. DISCUSSION: Determining how these two scalable strategies, alone and in sequence, perform for improving interpreter use, the mechanisms by which they do so, and at what cost, will provide critical insights for addressing a persistent cause of healthcare disparities. TRIAL REGISTRATION: NCT05591586.

Association between service readiness and PMTCT cascade effectiveness: a 2018 cross-sectional analysis from Manica province, Mozambique.

BACKGROUND: Despite high coverage of maternal and child  health services in Mozambique, prevention of mother-to-child transmission of HIV (PMTCT) cascade outcomes remain sub-optimal. Delivery effectiveness is modified by health system preparedness. Identifying modifiable factors that impact quality of care and service uptake can inform strategies to improve the effectiveness of PMTCT programs. We estimated associations between facility-level modifiable health system readiness measures and three PMTCT outcomes: Early infant diagnosis (polymerase chain reaction (PCR) before 8 weeks of life), PCR ever (before or after 8 weeks), and positive PCR test result. METHODS: A 2018 cross-sectional, facility-level survey was conducted in a sample of 36 health facilities covering all 12 districts in Manica province, central Mozambique, as part of a baseline assessment for the SAIA-SCALE trial (NCT03425136). Data on HIV testing outcomes among 3,427 exposed infants were abstracted from at-risk child service registries. Nine health system readiness measures were included in the analysis. Logistic regressions were used to estimate associations between readiness measures and pediatric HIV testing outcomes. Odds ratios (OR) and 95% confidence intervals (95%CI) are reported. RESULTS: Forty-eight percent of HIV-exposed infants had a PCR test within 8 weeks of life, 69% had a PCR test ever, and 6% tested positive. Staffing levels, glove stockouts, and distance to the reference laboratory were positively associated with early PCR (OR = 1.02 [95%CI: 1.01-1.02], OR = 1.73 [95%CI: 1.24-2.40] and OR = 1.01 [95%CI: 1.00-1.01], respectively) and ever PCR (OR = 1.02 [95%CI: 1.01-1.02], OR = 1.80 [95%CI: 1.26-2.58] and OR = 1.01 [95%CI: 1.00-1.01], respectively). Catchment area size and multiple NGOs supporting PMTCT services were associated with early PCR testing OR = 1.02 [95%CI: 1.01-1.03] and OR = 0.54 [95%CI: 0.30-0.97], respectively). Facility type, stockout of prophylactic antiretrovirals, the presence of quality improvement programs and mothers' support groups in the health facility were not associated with PCR testing. No significant associations with positive HIV diagnosis were found. CONCLUSION: Salient modifiable factors associated with HIV testing for exposed infants include staffing levels, NGO support, stockout of essential commodities and accessibility of reference laboratories. Our study provides insights into modifiable factors that could be targeted to improve PMTCT performance, particularly at small and rural facilities.