Assessing drivers of implementing "Scaling-up the Systems Analysis and Improvement Approach" for Prevention of Mother-to-Child HIV Transmission in Mozambique (SAIA-SCALE) over implementation waves.

BACKGROUND: The Systems Analysis and Improvement Approach (SAIA) is an evidence-based package of systems engineering tools originally designed to improve patient flow through the prevention of Mother-to-Child transmission of HIV (PMTCT) cascade. SAIA is a potentially scalable model for maximizing the benefits of universal antiretroviral therapy (ART) for mothers and their babies. SAIA-SCALE was a stepped wedge trial implemented in Manica Province, Mozambique, to evaluate SAIA's effectiveness when led by district health managers, rather than by study nurses. We present the results of a qualitative assessment of implementation determinants of the SAIA-SCALE strategy during two intensive and one maintenance phases. METHODS: We used an extended case study design that embedded the Consolidated Framework for Implementation Research (CFIR) to guide data collection, analysis, and interpretation. From March 2019 to April 2020, we conducted in-depth individual interviews (IDIs) and focus group discussions (FGDs) with district managers, health facility maternal and child health (MCH) managers, and frontline nurses at 21 health facilities and seven districts of Manica Province (Chimoio, Báruè, Gondola, Macate, Manica, Sussundenga, and Vanduzi). RESULTS: We included 85 participants: 50 through IDIs and 35 from three FGDs. Most study participants were women (98%), frontline nurses (49.4%), and MCH health facility managers (32.5%). An identified facilitator of successful intervention implementation (regardless of intervention phase) was related to SAIA's compatibility with organizational structures, processes, and priorities of Mozambique's health system at the district and health facility levels. Identified barriers to successful implementation included (a) inadequate health facility and road infrastructure preventing mothers from accessing MCH/PMTCT services at study health facilities and preventing nurses from dedicating time to improving service provision, and (b) challenges in managing intervention funds. CONCLUSIONS: The SAIA-SCALE qualitative evaluation suggests that the scalability of SAIA for PMTCT is enhanced by its fit within organizational structures, processes, and priorities at the primary level of healthcare delivery and health system management in Mozambique. Barriers to implementation that impact the scalability of SAIA include district-level financial management capabilities and lack of infrastructure at the health facility level. SAIA cannot be successfully scaled up to adequately address PMTCT needs without leveraging central-level resources and priorities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03425136 . Registered on 02/06/2018.

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.

Maternal and Child Health Care Service Disruptions and Recovery in Mozambique After Cyclone Idai: An Uncontrolled Interrupted Time Series Analysis.

INTRODUCTION: Climate change-related extreme weather events have increased in frequency and intensity, threatening people's health, particularly in places with weak health systems. In March 2019, Cyclone Idai devastated Mozambique's central region, causing infrastructure destruction, population displacement, and death. We assessed the impact of Idai on maternal and child health services and recovery in the Sofala and Manica provinces. METHODS: Using monthly district-level routine data from November 2016 to March 2020, we performed an uncontrolled interrupted time series analysis to assess changes in 10 maternal and child health indicators in all 25 districts before and after Idai. We applied a Bayesian hierarchical negative binomial model with district-level random intercepts and slopes to estimate Idai-related service disruptions and recovery. RESULTS: Of the 4.44 million people in Sofala and Manica, 1.83 (41.2%) million were affected. Buzi, Nhamatanda, and Dondo (all in Sofala province) had the highest proportion of people affected. After Idai, all 10 indicators showed an abrupt substantial decrease. First antenatal care visits per 100,000 women of reproductive age decreased by 23% (95% confidence interval [CI]=0.62, 0.96) in March and 11% (95% CI=0.75, 1.07) in April. BCG vaccinations per 1,000 children under age 5 years declined by 21% (95% CI=0.69, 0.90) and measles vaccinations decreased by 25% (95% CI=0.64, 0.87) in March and remained similar in April. Within 3 months post-cyclone, almost all districts recovered to pre-Idai levels, including Buzi, which showed a 22% and 13% relative increase in the number of first antenatal care visits and BCG, respectively. CONCLUSION: We found substantial health service disruptions immediately after Idai, with greater impact in the most affected districts. The findings suggest impressive recovery post-Idai, emphasizing the need to build resilient health systems to ensure quality health care during and after natural disasters.

Scaling-up the Systems Analysis and Improvement Approach for prevention of mother-to-child HIV transmission in Mozambique (SAIA-SCALE): a stepped-wedge cluster randomized trial.

BACKGROUND: The introduction of option B+-rapid initiation of lifelong antiretroviral therapy regardless of disease status for HIV-infected pregnant and breastfeeding women-can dramatically reduce HIV transmission during pregnancy, birth, and breastfeeding. Despite significant investments to scale-up Option B+, results have been mixed, with high rates of loss to follow-up, sub-optimal viral suppression, continued pediatric HIV transmission, and HIV-associated maternal morbidity. The Systems Analysis and Improvement Approach (SAIA) cluster randomized trial demonstrated that a package of systems engineering tools improved flow through the prevention of mother-to-child HIV transmission (PMTCT) cascade. This five-step, facility-level intervention is designed 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). This protocol describes a novel model for SAIA delivery (SAIA-SCALE) led by district nurse supervisors (rather than research nurses), and evaluation procedures, to serve as a foundation for national scale-up. METHODS: The SAIA-SCALE stepped wedge trial includes three implementation waves, each 12 months in duration. Districts are the unit of assignment, with four districts randomly assigned per wave, covering all 12 districts in Manica province, Mozambique. In each district, the three highest volume health facilities will receive the SAIA-SCALE intervention (totaling 36 intervention facilities). The RE-AIM framework will guide SAIA-SCALE's evaluation. Reach describes the proportion of clinics and population in Manica province reached, and sub-groups not reached. Effectiveness assesses impact on PMTCT process measures and patient-level outcomes. Adoption describes the proportion of districts/clinics adopting SAIA-SCALE, and determinants of adoption using the Organizational Readiness for Implementing Change (ORIC) tool. Implementation will identify SAIA-SCALE core elements and determinants of successful implementation using the Consolidated Framework for Implementation Research (CFIR). Maintenance describes the proportion of districts sustaining the intervention. We will also estimate the budget and program impact from the payer perspective for national scale-up. DISCUSSION: SAIA packages user-friendly systems engineering tools to guide decision-making by frontline health workers, and to identify low-cost, contextually appropriate PMTCT improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial is designed to test a model for national intervention scale-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT03425136 (registered 02/06/2018).