Alison S. Rustagi

Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial

BackgroundDespite significant increases in global health investment and the availability of low-cost, efficacious interventions to prevent mother-to-child HIV transmission (pMTCT) in low- and middle-income countries with high HIV burden, the translation of scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. A five-step, facility-level systems analysis and improvement intervention (SAIA) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies (step one: cascade analysis), guiding identification and prioritization of low-cost workflow modifications (step two: value stream mapping), and iteratively testing and redesigning these modifications (steps three through five). This protocol describes the SAIA intervention and methods to evaluate the intervention’s impact on reducing drop-offs along the pMTCT cascade.MethodsThis study employs a two-arm, longitudinal cluster randomized trial design. The unit of randomization is the health facility. A total of 90 facilities were identified in Côte d’Ivoire, Kenya and Mozambique (30 per country). A subset was randomly selected and assigned to intervention and comparison arms, stratified by country and service volume, resulting in 18 intervention and 18 comparison facilities across all three countries, with six intervention and six comparison facilities per country. The SAIA intervention will be implemented for six months in the 18 intervention facilities. Primary trial outcomes are designed to assess improvements in the pMTCT service cascade, and include the percentage of pregnant women being tested for HIV at the first antenatal care visit, the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy, and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum. The Consolidated Framework for Implementation Research (CFIR) will guide collection and analysis of qualitative data on implementation process.DiscussionThis study is a pragmatic trial that has the potential benefit of improving maternal and infant outcomes by reducing drop-offs along the pMTCT cascade. The SAIA intervention is designed to provide simple tools to guide decision-making for pMTCT program staff at the facility level, and to identify low cost, contextually appropriate pMTCT improvement strategies.Trial registrationClinicalTrials.gov NCT02023658

Cervical Screening and Cervical Cancer Death Among Older Women: A Population-Based, Case-Control Study

Recent research suggests that cervical screening of older women is associated with a considerable decrease in cervical cancer incidence. We sought to quantify the efficacy of cervical cytology screening to reduce death from this disease. Among enrollees of 2 US health plans, we compared Papanicolaou smear screening histories of women aged 55-79 years who died of cervical cancer during 1980-2010 (cases) to those of women at risk of cervical cancer (controls). Controls were matched 2:1 to cases on health plan, age, and enrollment duration. Cytology screening during the detectable preclinical phase, estimated as the 5-7 years before diagnosis during which cervical neoplasia is asymptomatic but cytologically detectable, was ascertained from medical records. A total of 39 cases and 80 controls were eligible. The odds ratio of cervical cancer death associated with screening during the presumed detectable preclinical phase was 0.26 (95% confidence interval: 0.10, 0.63) after adjustment for matching characteristics, smoking, marital status, and race/ethnicity using logistic regression. We estimate that cervical cytology screening of all women aged 55-79 years in the United States could avert 630 deaths annually. These results provide a minimum estimate of the efficacy of human papillomavirus DNA screening-a more sensitive test-to reduce cervical cancer death among older women.

What does high and low have to do with it? Performance classification to identify health system factors associated with effective prevention of mother-to-child transmission of HIV delivery in Mozambique

Efforts to implement and take to scale highly efficacious, low‐cost interventions to prevent mother‐to‐child HIV transmission (pMTCT) have been a cornerstone of reproductive health services in sub‐Saharan Africa for over a decade. Yet efforts to increase access and utilization of these services remain far from optimal. This study developed and applied an approach to systematically classify pMTCT performance to identify modifiable health system factors associated with pMTCT performance which may be replicated in other pMTCT systems.

Perspectives of key stakeholders regarding task shifting of care for HIV patients in Mozambique: a qualitative interview-based study with Ministry of Health leaders, clinicians, and donors

BackgroundTask shifting is a common strategy to deliver antiretroviral therapy (ART) in resource-limited settings and is safe and effective if implemented appropriately. Consensus among stakeholders is necessary to formulate clear national policies that maintain high-quality care. We sought to understand key stakeholders’ opinions regarding task shifting of HIV care in Mozambique and to characterize which specific tasks stakeholders considered appropriate for specific cadres of health workers.MethodsNational and provincial Ministry of Health leaders, representatives from donor and non-governmental organizations (NGOs), and clinicians providing HIV care were intentionally selected to represent diverse viewpoints. Using open- and closed-ended questions, interviewees were asked about their general support of task shifting, its potential advantages and disadvantages, and whether each of seven cadres of non-physician health workers should perform each of eight tasks related to ART provision. Responses were tallied overall and stratified by current job category. Interviews were conducted between November 2007 and June 2008.ResultsOf 62 stakeholders interviewed, 44% held leadership positions in the Ministry of Health, 44% were clinicians providing HIV care, and 13% were donors or employed by NGOs; 89% held a medical degree. Stakeholders were highly supportive of physician assistants performing simple ART-related tasks and unanimous in opposing community health workers providing any ART-related services. The most commonly cited motives to implement task shifting were to increase ART access, decrease physician workload, and decrease patient wait time, whereas chief concerns included reduced quality of care and poor training and supervision. Support for task shifting was higher among clinicians than policy and programme leaders for three specific task/cadre combinations: general mid-level nurses to initiate ART in adults (supported by 75% of clinicians vs. 41% of non-clinicians) and in pregnant women (75% vs. 34%, respectively) and physician assistants to change ART regimens in adults (43% vs. 24%, respectively).ConclusionsStakeholders agreed on some ART-related task delegation to lower health worker cadres. Clinicians were more likely to support task shifting than policy and programme leaders, perhaps motivated by their front-line experiences. Harmonizing policy and programme managers’ views with those of clinicians will be important to formulate and implement clear policy.

Evaluation of a Systems Analysis and Improvement Approach to Optimize Prevention of Mother-To-Child Transmission of HIV Using the Consolidated Framework for Implementation Research.

Background:Despite large investments to prevent mother-to-child-transmission (PMTCT), pediatric HIV elimination goals are not on track in many countries. The Systems Analysis and Improvement Approach (SAIA) study was a cluster randomized trial to test whether a package of systems engineering tools could strengthen PMTCT programs. We sought to (1) define core and adaptable components of the SAIA intervention, and (2) explain the heterogeneity in SAIAs success between facilities. Methods:The Consolidated Framework for Implementation Research (CFIR) guided all data collection efforts. CFIR constructs were assessed in focus group discussions and interviews with study and facility staff in 6 health facilities (1 high-performing and 1 low-performing site per country, identified by study staff) in December 2014 at the end of the intervention period. SAIA staff identified the interventions core and adaptable components at an end-of-study meeting in August 2015. Two independent analysts used CFIR constructs to code transcripts before reaching consensus. Results:Flow mapping and continuous quality improvement were the core to the SAIA in all settings, whereas the PMTCT cascade analysis tool was the core in high HIV prevalence settings. Five CFIR constructs distinguished strongly between high and low performers: 2 in inner setting (networks and communication, available resources) and 3 in process (external change agents, executing, reflecting and evaluating). Discussion:The CFIR is a valuable tool to categorize elements of an intervention as core versus adaptable, and to understand heterogeneity in study implementation. Future intervention studies should apply evidence-based implementation science frameworks, like the CFIR, to provide salient data to expand implementation to other settings.

Health facility factors and quality of services to prevent mother-to-child HIV transmission in Côte d'Ivoire, Kenya, and Mozambique.

This study aimed to identify facility-level characteristics associated with prevention of mother-to-child HIV transmission service quality. This cross-sectional study sampled 60 health facilities in Mozambique, Côte d’Ivoire, and Kenya (20 per country). Performance score – the proportion of pregnant women tested for HIV in first antenatal care visit, multiplied by the proportion of HIV-positive pregnant women who received appropriate antiretroviral medications – was calculated for each facility using routine data from 2012 to 2013. Facility characteristics were ascertained during on-site visits, including workload. Associations between facility characteristics and performance were quantified using generalized linear models with robust standard errors, adjusting for country. Over six months, facilities saw 38,611 first antenatal care visits in total. On-site CD4 testing, Pima CD4 machine, air conditioning, and low or high (but not mid-level) patient volume were each associated with higher performance scores. Each additional first antenatal care visit per nurse per month was associated with a 4% (95% confidence interval: 1%–6%) decline in the odds that an HIV-positive pregnant woman would receive both HIV testing and antiretroviral medications. Physician workload was only modestly associated with performance. Investments in infrastructure and human resources – particularly nurses – may be critical to improve prevent mother-to-child HIV transmission service delivery and protect infants from HIV.

Implementation and Operational Research: Impact of a Systems Engineering Intervention on PMTCT Service Delivery in Côte d'Ivoire, Kenya, Mozambique: A Cluster Randomized Trial.

Methods: Thirty-six health facilities in Côte d’Ivoire, Kenya, and Mozambique were randomized to usual care or a systems engineering intervention, stratified by country and volume. The intervention guided facility staff to iteratively identify and then rectify barriers to PMTCT implementation. Registry data quantified coverage of HIV testing during first antenatal care visit, antiretrovirals (ARVs) for HIV-positive pregnant women, and screening HIV-exposed infants (HEI) for HIV by 6–8 weeks. We compared the change between baseline (January 2013–January 2014) and postintervention (January 2015–March 2015) periods using t-tests. All analyses were intent-to-treat.

Implementation and Operational Research: Impact of a Systems Engineering Intervention on PMTCT Service Delivery in Côte dʼIvoire, Kenya, Mozambique

Methods: Thirty-six health facilities in Côte d’Ivoire, Kenya, and Mozambique were randomized to usual care or a systems engineering intervention, stratified by country and volume. The intervention guided facility staff to iteratively identify and then rectify barriers to PMTCT implementation. Registry data quantified coverage of HIV testing during first antenatal care visit, antiretrovirals (ARVs) for HIV-positive pregnant women, and screening HIV-exposed infants (HEI) for HIV by 6–8 weeks. We compared the change between baseline (January 2013–January 2014) and postintervention (January 2015–March 2015) periods using t-tests. All analyses were intent-to-treat.

Impact of a systems engineering intervention on PMTCT service delivery in Côte d’Ivoire, Kenya, Mozambique

Methods: Thirty-six health facilities in Côte d’Ivoire, Kenya, and Mozambique were randomized to usual care or a systems engineering intervention, stratified by country and volume. The intervention guided facility staff to iteratively identify and then rectify barriers to PMTCT implementation. Registry data quantified coverage of HIV testing during first antenatal care visit, antiretrovirals (ARVs) for HIV-positive pregnant women, and screening HIV-exposed infants (HEI) for HIV by 6–8 weeks. We compared the change between baseline (January 2013–January 2014) and postintervention (January 2015–March 2015) periods using t-tests. All analyses were intent-to-treat.