Cyrus Mugo, Irene Njuguna, Margaret Nduati, Vincent Omondi, Verlinda Otieno, Florence Nyapara, Elizabeth Mabele, Hellen Moraa, Kenneth Sherr, Irene Inwani, Elizabeth Maleche-Obimbo, Dalton Wamalwa, Grace John-Stewart, Jennifer Slyker, Anjuli D Wagner
University of Washington affiliated authors are displayed in bold.
Published: September 2020
Lúcia Vieira, Arlete Miloque Mahumane, Manuel Napua, Falume Chale, João Luís Manuel, Jessica Greenberg Cowan, Kenneth Sherr, Rachel R. Chapman & James T. Pfeiffer
University of Washington affiliated authors are displayed in bold.
Published: March 2020
Early infant diagnosis (EID) of HIV-exposed and initiation of HIV-positive infants on anti-retroviral therapy (ART) requires a well-coordinated cascade of care. Loss-to-follow-up (LTFU) can occur at multiple steps and effective EID is impeded by human resource constraints, difficulty with patient tracking, and long waiting periods. The objective of this research was to conduct formative research to guide the development of an intervention to improve the pediatric HIV care cascade in central Mozambique. The study was conducted in Manica and Sofala Provinces where the adult HIV burden is higher than the national average. The research focused on 3 large clinics in each province, along the highly populated Beira corridor.
The research was conducted in 2014 over 3 months at six facilities and consisted of 1) patient flow mapping and collection of health systems data from postpartum, child-at-risk, and ART service registries, 2) measurement of clinic waiting times, and 3) patient and health worker focus groups.
HIV testing and ART initiation coverage for mothers tends to be high, but EID and pediatric ART initiation are hampered by lack of patient tracking, long waiting times, and inadequate counseling to navigate the care cascade. About 76% of HIV-positive infants were LTFU and did not initiate ART.
Effective interventions to reduce LTFU in EID and improve pediatric ART initiation should focus on patient tracking, active follow-up of defaulting patients, reduction in EID turn-around times for PCR results, and initiation of ART by nurses in child-at-risk services.
Retrospectively registered, ISRCTN67747315, July 24, 2019.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Arianna Rubin Means, Christopher G. Kemp, Marie-Claire Gwayi-Chore, Sarah Gimbel, Caroline Soi, Kenneth Sherr, Bradley H. Wagenaar, Judith N. Wasserheit, & Bryan J. Weiner
University of Washington affiliated authors are displayed in bold.
Published: March 2020
The Consolidated Framework for Implementation Research (CFIR) is a determinants framework that may require adaptation or contextualization to fit the needs of implementation scientists in low- and middle-income countries (LMICs). The purpose of this review is to characterize how the CFIR has been applied in LMIC contexts, to evaluate the utility of specific constructs to global implementation science research, and to identify opportunities to refine the CFIR to optimize utility in LMIC settings.
A systematic literature review was performed to evaluate the use of the CFIR in LMICs. Citation searches were conducted in Medline, CINAHL, PsycINFO, CINAHL, SCOPUS, and Web of Science. Data abstraction included study location, study design, phase of implementation, manner of implementation (ex., data analysis), domains and constructs used, and justifications for use, among other variables. A standardized questionnaire was sent to the corresponding authors of included studies to determine which CFIR domains and constructs authors found to be compatible with use in LMICs and to solicit feedback regarding ways in which CFIR performance could be improved for use in LMICs.
Our database search yielded 504 articles, of which 34 met final inclusion criteria. The studies took place across 21 countries and focused on 18 different health topics. The studies primarily used qualitative study designs (68%). Over half (59%) of the studies applied the CFIR at study endline, primarily to guide data analysis or to contextualize study findings. Nineteen (59%) of the contacted authors participated in the survey. Authors unanimously identified culture and engaging as compatible with use in global implementation research. Only two constructs, patient needs and resources and individual stages of change were commonly identified as incompatible with use. Author feedback centered on team level influences on implementation, as well as systems characteristics, such as health system architecture. We propose a “Characteristics of Systems” domain and eleven novel constructs be added to the CFIR to increase its compatibility for use in LMICs.
These additions provide global implementation science practitioners opportunities to account for systems-level determinants operating independently of the implementing organization. Newly proposed constructs require further reliability and validity assessments.
PROSPERO, CRD42018095762
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Sarah Gimbel, Ana Olga Mocumbi, Kristjana Ásbjörnsdóttir, Joana Coutinho, Leonel Andela, Bonifacio Cebola, Heidi Craine, Jonny Crocker, Leecreesha Hicks, Sarah Holte, Rodrigues Hossieke, Edgar Itai, Carol Levin, Nelia Manaca, Filipe Murgorgo, Miguel Nhumba, James Pfeiffer, Isaias Ramiro, Keshet Ronen, Nona Sotoodehnia, Onei Uetela, Anjuli Wagner, Bryan J. Weiner, & Kenneth Sherr
University of Washington affiliated authors are displayed in bold.
Published: March 2020
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.
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.
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.
Registered 09/13/2019; NCT04088656).
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Ashlinn K. Quinn, Gila Neta, Rachel Sturke, Christopher O. Olopade, Suzanne L. Pollard, Kenneth Sherr and Joshua P. Rosenthal
University of Washington affiliated authors are displayed in bold.
Published: December 2019
The use of models and frameworks to design and evaluate strategies to improve delivery of evidence-based interventions is a foundational element of implementation science. To date, however, evaluative implementation science frameworks such as Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) have not been widely employed to examine environmental health interventions. We take advantage of a unique opportunity to utilize and iteratively adapt the RE-AIM framework to guide NIH-funded case studies of the implementation of clean cooking fuel programs in eleven low- and middle-income countries.
We used existing literature and expert consultation to translate and iteratively adapt the RE-AIM framework across several stages of the NIH Clean Cooking Implementation Science case study project. Checklists and templates to guide investigators were developed at each stage.
The RE-AIM framework facilitated identification of important emerging issues across this set of case studies, in particular highlighting the fact that data associated with certain important outcomes related to health and welfare are chronically lacking in clean fuel programs. Monitoring of these outcomes should be prioritized in future implementation efforts. As RE-AIM was not originally designed to evaluate household energy interventions, employing the framework required adaptation. Specific adaptations include the broadening of Effectiveness to encompass indicators of success toward any stated programmatic goal, and expansion of Adoption to include household-level uptake of technology.
The RE-AIM implementation science framework proved to be a useful organizing schema for 11 case studies of clean fuel cooking programs, in particular highlighting areas requiring emphasis in future research and evaluation efforts. The iterative approach used here to adapt an implementation science framework to a specific programmatic goal may be of value to other multi-country program efforts, such as those led by international development agencies. The checklists and templates developed for this project are publicly available for others to use and/or further modify.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Anjuli D. Wagner, Sarah Gimbel, Kristjana H. Ásbjörnsdóttir, Peter Cherutich, Joana Coutinho, Jonny Crocker, Emiliae Cruz, Fatima Cuembelo, Vasco Cumbe, McKenna Eastment, Jennifer Einberg, Florencia Floriano, Douglas Gaitho, Brandon L. Guthrie, Grace John-Stewart, Alex H. Kral, Barrot H. Lambdin, Shan Liu, Martin Bcom Maina, Nelia Manaca, Mika Matsuzaki, Loris Mattox, Nancy Mburu, R. Scott McClelland, Mark A. Micek, Ana Olga Mocumbi, Albertoe Muanido, Ruth Nduati, Irene N. Njuguna, Geoffrey Oluoch, Laura B. Oyiengo, Keshet Ronen, Caroline Soi, Bradley H. Wagenaar, George Wanje, Lynn D. Wenger, and Kenneth Sherr
University of Washington affiliated authors are displayed in bold.
Published: December 2019
Caroline Soi, Joseph B. Babigumira, Baltazar Chilundo, Vasco Muchanga, Luisa Matsinhe, Sarah Gimbel, Orvalho Augusto & Kenneth Sherr
University of Washington affiliated authors are displayed in bold.
Published: October 2019
Cost is an important determinant of health program implementation. In this study, we conducted a comprehensive evaluation of the implementation strategy of Mozambique’s school-based HPV vaccine demonstration project. We sought to estimate the total costs for the program, cost per fully immunized girl (FIG), and compute projections for the total cost of implementing a similar national level vaccination program.
We collected primary data through document review, participatory observation, and key informant interviews at all levels of the national health system and Ministry of Education. We used a combination of micro-costing methods—identification and measurement of resource quantities and valuation by application of unit costs, and gross costing—for consideration of resource bundles as they apply to the number of vaccinated girls. We extrapolated the cost per FIG to the HPV-vaccine-eligible population of Mozambique, to demonstrate the projected total annual cost for two scenarios of a similarly executed HPV vaccine program.
The total cost of the Mozambique HPV vaccine demonstration project was $523,602. The mean cost per FIG was $72 (Credibility Intervals (CI): $62 - $83) in year one, $38 (CI: $37 - $40) in year two, and $54 CI: $49 - $61) for years one and two. The mean cost per FIG with the third HPV vaccine dose excluded from consideration was $60 (CI: $50 - $72) in year one, $38 (CI: $31 - $46) in year two, and $48 (CI: $42 - $55) for years one and two. The mean cost per FIG when only one HPV vaccine dose is considered was $30 (CI: $27 - $33)) in year one, $19 (CI: $15–$23) in year two, and $24 (CI: $22–$27) for both years. The projected annual cost of a two-and one-dose vaccine program targeting all 10-year-old girls in the country was $18.2 m (CI: $15.9 m - $20.7 m) and $9 m (CI: $8 m - $10 m) respectively.
National adaptation and scale-up of Mozambique’s school-based HPV vaccine strategy may result in substantial costs depending on dosing. For sustainability, stakeholders will need to negotiate vaccine price and achieve higher efficiency in startup activities and demand creation.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Nami Kawakyu, Ruth Nduati, Khátia Munguambe, Joana Coutinho, Nancy Mburu, Georgina DeCastro, Celso Inguane, Andrew Zunt, Neil Abburi, Kenneth Sherr, & Sarah Gimbel
University of Washington affiliated authors are displayed in bold.
Published: March 2019
Prevention of mother-to-child HIV transmission (PMTCT) care cascade failures drive pediatric HIV infections in sub-Saharan Africa. As nurses’ clinical and management role in PMTCT expand, decision-support tools for nurses are needed to facilitate identification of cascade inefficiencies and solutions. The mobile phone–based PMTCT cascade analysis tool (mPCAT) provides health facility staff a quick summary of the number of patients and percentage drop-off at each step of the PMCTC care cascade, as well as how many women-infant pairs would be retained if a step was optimized.
The objective of this study was to understand and improve the mPCAT’s core usability factors and assess the health workers’ experience with using the mPCAT.
Overall, 2 rounds of usability testing were conducted with health workers from 4 clinics and leading experts in maternal and child health in Kenya and Mozambique using videotaped think aloud assessment techniques. Semistructured group interviews gauged the understanding of mPCAT’s core usability factors, based on the Nielsen Usability Framework, followed by development of cognitive demand tables describing the needed mPCAT updates. Post adaptation, feasibility was assessed in 3 high volume clinics over 12 weeks. Participants completed a 5-point Likert questionnaire designed to measure ease of use, convenience of integration into work, and future intention to use the mPCAT. Focus group discussions with nurse participants at each facility and in-depth interviews with nurse managers were also conducted to assess the acceptability, use, and recommendations for adaptations of the mPCAT.
Usability testing with software engineers enabled real-time feedback to build a tool following empathic design principles. The revised mPCAT had improved navigation and simplified data entry interface, with only 1 data entry field per page. Improvements to the results page included a data visualization feature and the ability to share results through WhatsApp. Coding was simplified to enable future revisions by nontechnical staff—critical for context-specific adaptations for scale-up. Health care workers and facility managers found the tool easy to use (mean=4.3), used the tool very often (mean=4.1), and definitely intended to continue to use the tool (mean=4.8). Ease of use was the most common theme identified, with emphasis on how the tool readily informed system improvement decision making.
The mPCAT was well accepted by frontline health workers and facility managers. The collaborative process between software developer and user led to the development of a more user-friendly, context-specific tool that could be easily integrated into routine clinical practice and workflow. The mPCAT gave frontline health workers and facility managers an immediate, direct, and tangible way to use their clinical documentation and routinely reported data for decision making for their own clinical practice and facility-level improvements.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Kenneth Sherr, Kristjana Ásbjörnsdóttir, Jonny Crocker, Joana Coutinho, Maria de Fatima Cuembelo, Esperança Tavede, Nélia Manaca, Keshet Ronen, Felipe Murgorgo, Ruanne Barnabas, Grace John-Stewart, Sarah Holte, Bryan J. Weiner, James Pfeiffer & Sarah Gimbel
University of Washington affiliated authors are displayed in bold.
Published: April 2019
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.
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.
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.
ClinicalTrials.gov NCT03425136 (registered 02/06/2018).
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Caroline Soi, Sarah Gimbel, Baltazar Chilundo, Vasco Muchanga, Luisa Matsinhe and Kenneth Sherr
University of Washington affiliated authors are displayed in bold.
Published: December 2018
Since 2012 Gavi, the Vaccine Alliance has provided financial support for HPV vaccine introduction in low- and middle-income countries (LMICs); however, funding has been contingent on establishing a demonstration project prior to national scale-up, in order to gauge effectiveness of delivery models. Although by 2016, most beneficiary countries had completed demonstration projects, few have scaled up delivery nationwide. An important barrier was the dearth of published, country-specific implementation recommendations. We employed the Consolidated Framework for Implementation Research (CFIR) as a lens to identify drivers of heterogeneous (dissimilar) implementation performance during Mozambique’s 2-year demonstration project. Mozambique presents a compelling example as the country conducted demonstration projects in three different districts with extremely different economic resources and sociocultural practices.
A post implementation interpretive evaluation was undertaken. Forty key informant interviews were conducted with district and health facility immunization staff, Ministry of Education managers, and teachers across the three demonstration districts, central level informants from MOH, research institutes, and immunization program partners. We compared valence and strength ratings of CFIR constructs, across diverse implementation sites, so as to explain drivers and barriers to implementation success. Two researchers coded separately, and subsequent content analysis followed pre-defined CFIR construct themes.
Eighteen constructs emerged from informants’ responses as implementation influencers. Adaptability was identified as an important construct because delivery modalities needed to meet differing levels of girls’ school attendance. Expanding outside of school-based delivery was needed in the low-performing district, making the vaccine delivery process more complex. Available resources varied across the three sites, with one site receiving direct Gavi support, while others received primarily state-based support. These latter sites reported considerably more implementation bottlenecks, in part related to weaker infrastructural characteristics and insufficient organizational incentives. Health workers’ beliefs in importance of vaccines and an organizational culture of making personal sacrifice for immunization program activities drove implementation performance. Advocacy and social mobilization through the right opinion leaders and champions generated higher demand.
HPV vaccination presents a pertinent opportunity for the prevention of cervical cancer in Mozambique, sub-Saharan Africa, and other LMICs. However, important barriers to broad-scale implementation exist. We recommend the development of local and global strategies to overcome barriers and facilitate its expanded utilization.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**