Results of a cluster randomized trial testing the Systems Analysis and Improvement Approach to increase cervical cancer screening in family planning clinics in Mombasa County, Kenya.

BACKGROUND: Cervical cancer is the leading cause of cancer death in Kenyan women. Integrating cervical cancer screening into family planning (FP) clinics is a promising strategy to improve health for reproductive-aged women. The objective of this cluster randomized trial was to test the efficacy of an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), as a tool to increase cervical cancer screening in FP clinics in Mombasa County, Kenya. METHODS: Twenty FP clinics in Mombasa County were randomized 1:1 to SAIA versus usual procedures. SAIA has five steps: (1) cascade analysis tool to understand the cascade and identify inefficiencies, (2) sequential process flow mapping to identify bottlenecks, (3) develop and implement workflow modifications (micro-interventions) to address identified bottlenecks, (4) assess the micro-intervention in the cascade analysis tool, and (5) repeat the cycle. Prevalence ratios were calculated using Poisson regression with robust standard errors to compare the proportion of visits where women were screened for cervical cancer in SAIA clinics compared to control clinics. RESULTS: In the primary intent-to-treat analysis in the last quarter of the trial, 2.5% (37/1507) of visits with eligible FP clients at intervention facilities included cervical cancer screening compared to 3.7% (66/1793) in control clinics (prevalence ratio [PR] 0.67, 95% CI 0.45-1.00). When adjusted for having at least one provider trained to perform cervical cancer screening at baseline, there was no significant difference between screening in intervention clinics compared to control clinics (adjusted PR 1.14, 95% CI 0.74-1.75). CONCLUSIONS: The primary analysis did not show an effect on cervical cancer screening. However, the COVID-19 pandemic and a healthcare worker strike likely impacted SAIA's implementation with significant disruptions in FP care delivery during the trial. While SAIA's data-informed decision-making and clinic-derived solutions are likely important, future work should directly study the mechanisms through which SAIA operates and the influence of contextual factors on implementation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03514459. Registered on April 19, 2018.

'I understood the texting process well'. Participant perspectives on usability and acceptability of SMS-based telehealth follow-up after voluntary medical male circumcision in South Africa.

Background: Voluntary medical male circumcision (MC) is a biomedical HIV prevention method that requires post-operative follow-up for healing confirmation. Recent research found that a two-way texting (2wT) app providing SMS-based telehealth for MC patients was safe and reduced provider workload. We evaluated 2wT usability among MC clients in South Africa assigned the 2wT intervention within a larger randomized controlled trial (RCT) of 2wT safety and workload. Methods: This quantitative usability study is within an RCT where 547 men used 2wT to interact with an MC provider via SMS. The sub-study involved the first 100 men assigned to 2wT who completed a usability survey 14 days after surgery. Acceptability was assessed through 2wT response rates of the 547 men. Regression models analyzed associations between age, wage, location, potential adverse events (AEs), and 2wT responses. Results: Men assigned to 2wT found it safe, comfortable, and convenient, reporting time and cost savings. High response rates (88%) to daily messages indicated acceptability. Age, wage, and location didn't affect text responses or potential AEs. Conclusion: 2wT for post-MC follow-up was highly usable and acceptable, suggesting its viability as an alternative to in-person visits. It enhanced confidence in wound self-management. This SMS-based telehealth can enhance MC care quality and be adapted to similar contexts for independent healing support, particularly for men.

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.

A cross-sectional study of the prevalence, barriers, and facilitators of cervical cancer screening in family planning clinics in Mombasa County, Kenya.

BACKGROUND: Cervical cancer is the most common cancer in sub-Saharan Africa. With appropriate screening and treatment, cervical cancer can be prevented. In Kenya, cervical cancer screening is recommended for all women of reproductive age who visit a health facility. In particular, the Kenyan Ministry of Health has tasked family planning clinics and HIV clinics with implementing cervical cancer screening as part of the overall cervical cancer screening strategy. A cross-sectional survey was conducted to understand cervical cancer screening practices and explore clinic-level barriers and facilitators to screening in family planning clinics (FP) in Mombasa County, Kenya. METHODS: Structured interviews were conducted with randomly sampled FP clinic managers to collect information about clinic size, location, type, management support, infrastructure, screening practices, and availability of screening commodities. Data were abstracted from FP registers for a 15-month period from October 1, 2017 until December 31, 2018 to understand cervical cancer screening prevalence. Generalized linear models were used to calculate prevalence ratios (PR) and identify clinic-level correlates of reporting any cervical cancer screening. RESULTS: A total of 70 clinics were sampled, 54% (38) were urban and 27% (19) were public facilities. The median number of staff in a clinic was 4 (interquartile range [IQR] 2-6) with a median of 1 provider trained to perform screening (IQR 0-3). Fifty-four percent (38/70) of clinic managers reported that their clinics performed cervical cancer screening. Of these, only 87% (33) and 71% (27) had dependable access to speculums and acetic acid, respectively. Being a public FP clinic was associated with higher prevalence of reported screening (14/38 [37%] vs 6/32 [16%]; prevalence rate ratio [PR] 1.57, 95%CI 1.05-2.33). Clinics that reported cervical cancer screening were much more likely to have at least one provider trained to perform cervical cancer screening (84%, 32/38) compared to clinics that did not report screening (28%, 9/32; PR 3.77, 95%CI 1.82-7.83). CONCLUSION: Integration of cervical cancer screening into FP clinics offers great potential to reach large numbers of reproductive-aged women. Increasing training of healthcare providers and ensuring adequate commodity supplies in FP clinics offer concrete solutions to increase screening in a largely unscreened population.

The prevalence of hypertension and its distribution by sociodemographic factors in Central Mozambique: a cross sectional study.

BACKGROUND: Hypertension (HTN) is a major risk factor for cardiovascular diseases, and its prevalence has been rising in low- and middle-income countries. The current study describes HTN prevalence in central Mozambique, association between wealth and blood pressure (BP), and HTN monitoring and diagnosis practice among individuals with elevated BP. METHODS: The study used data from a cross-sectional, representative household survey conducted in Manica and Sofala provinces, Mozambique. There were 4101 respondents, aged ≥20 years. We measured average systolic and diastolic BP (SBP and DBP) from three measurements taken in the household setting. Elevated BP was defined as having either SBP ≥140 or DBP ≥90 mmHg. RESULTS: The mean age of the participants was 36.7 years old, 59.9% were women, and 72.5% were from rural areas. Adjusting for complex survey weights, 15.7% (95%CI: 14.0 to 17.4) of women and 16.1% (13.9 to 18.5) of men had elevated BP, and 7.5% (95% CI: 6.4 to 8.7) of the overall population had both SBP ≥140 and DBP ≥90 mmHg. Among participants with elevated BP, proportions of participants who had previous BP measurement and HTN diagnosis were both low (34.9% (95% CI: 30.0 to 40.1) and 12.2% (9.9 to 15.0) respectively). Prior BP measurement and HTN diagnosis were more commonly reported among hypertensive participants with secondary or higher education, from urban areas, and with highest relative wealth. In adjusted models, wealth was positively associated with higher SBP and DBP. CONCLUSIONS: The current study found evidence of positive association between wealth and BP. The prevalence of elevated BP was lower in Manica and Sofala provinces than the previously estimated national prevalence. Previous BP screening and HTN diagnosis were uncommon in our study population, especially among rural residents, individuals with lower education levels, and those with relatively less wealth. As the epidemiological transition advances in Mozambique, there is a need to develop and implement strategies to increase BP screening and deliver appropriate clinical services, as well as to encourage lifestyle changes among people at risk of developing hypertension in near future.

Global health systems partnerships: a mixed methods analysis of Mozambique's HPV vaccine delivery network actors.

BACKGROUND: Global health partnerships have expanded exponentially in the last two decades with Gavi, the Vaccine Alliance considered the model's pioneer and leader because of its vaccination programs' implementation mechanism. Gavi, relies on diverse domestic and international partners to carry out the programs in low- and middle-income countries under a partnership engagement framework (PEF). In this study, we utilized mixed methods to examine Mozambique's Gavi driven partnership network which delivered human papillomavirus (HPV) vaccine during the demonstration phase. METHODS: Qualitative tools gauged contextual factors, prerequisites, partner performance and practices while a social network analysis (SNA) survey measured the partnership structure and perceived added value in terms of effectiveness, efficiency and country ownership. Forty key informants who were interviewed included frontline Ministry of Health workers, Ministry of Education staff and supporting partner organization members, of whom 34 participated in the social network analysis survey. RESULTS: Partnership structure SNA connectivity measurement scores of reachability (100%) and average distance (2.5), were high, revealing a network of very well-connected HPV vaccination implementation collaborators. Such high scores reflect a network structure favorable for rapid and widespread diffusion of information, features necessary for engaging and handling multiple implementation scales. High SNA effectiveness and efficiency measures for structural holes (85%) and low redundancy (30%) coupled with high mean perceived effectiveness (97.6%) and efficiency (79.5%) network outcome scores were observed. Additionally, the tie strength average score of 4.1 on a scale of 5 denoted high professional trust. These are all markers of a collaborative partnership environment in which disparate institutions and organizations leveraged each entity's comparative advantage. Lower perceived outcome scores for country ownership (24%) were found, with participants citing the prominent role of several out-of-country partner organizations as a major obstacle. CONCLUSIONS: While there is room for improvement on the country ownership aspects of the partnership, the expanded, diverse and inclusive collaboration of institutions and organizations that implemented the Mozambique HPV vaccine demonstration project was effective and efficient. We recommend that the country adapt a similar model during national scale up of HPV vaccination.

HIV-exposed infant follow-up in Mozambique: formative research findings for the design of a cluster randomized controlled trial to improve testing and ART initiation.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Retrospectively registered, ISRCTN67747315, July 24, 2019.

Cascade Analysis: An Adaptable Implementation Strategy Across HIV and Non-HIV Delivery Platforms.

BACKGROUND: Cascades have been used to characterize sequential steps within a complex health system and are used in diverse disease areas and across prevention, testing, and treatment. Routine data have great potential to inform prioritization within a system, but are often inaccessible to frontline health care workers (HCWs) who may have the greatest opportunity to innovate health system improvement. METHODS: The cascade analysis tool (CAT) is an Excel-based, simple simulation model with an optimization function. It identifies the step within a cascade that could most improve the system. The original CAT was developed for HIV treatment and the prevention of mother-to-child transmission of HIV. RESULTS: CAT has been adapted 7 times: to a mobile application for prevention of mother-to-child transmission; for hypertension screening and management and for mental health outpatient services in Mozambique; for pediatric and adolescent HIV testing and treatment, HIV testing in family planning, and cervical cancer screening and treatment in Kenya; and for naloxone distribution and opioid overdose reversal in the United States. The main domains of adaptation have been technical-estimating denominators and structuring steps to be binary sequential steps-as well as logistical-identifying acceptable approaches for data abstraction and aggregation, and not overburdening HCW. DISCUSSION: CAT allows for prompt feedback to HCWs, increases HCW autonomy, and allows managers to allocate resources and time in an equitable manner. CAT is an effective, feasible, and acceptable implementation strategy to prioritize areas most requiring improvement within complex health systems, although adaptations are being currently evaluated.

Implementation strategy and cost of Mozambique's HPV vaccine demonstration project.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Performance of family planning clinics in conducting recommended HIV counseling and testing in Mombasa County, Kenya: a cross-sectional study.

BACKGROUND: A high proportion of African women utilize family planning (FP) services. Accordingly, incorporating HIV testing into FP services may strategically target the first WHO 90-90-90 goal of 90% of people living with HIV knowing their status. METHODS: The objective of this analysis was to determine the proportion of new FP clients counseled and tested for HIV, as well as correlates of HIV testing, in a random sample of 58 FP clinics in Mombasa County, Kenya. Structured interviews of FP clinic managers collected data on characteristics of FP clinics and staff. Study staff performed a 3-month review of FP registers, summarizing new client HIV testing and counseling (HTC). Because overall rates of HTC were quite low, a binary variable was created comparing clinics performing any HIV counseling and/or testing to clinics performing none. Generalized linear models were used to calculate prevalence ratios (PR) and identify correlates of HTC. Factors associated with any HTC with a p-value < 0.10 in univariate analysis were included in a multivariate analysis. RESULTS: Of the 58 FP clinics, 26 (45%) performed any counseling for HIV testing, and 23 (40%) performed any HIV testing. Counseling for HIV testing was conducted for 815/4389 (19%) new clients, and HIV testing was performed for 420/4389 (10%). Clinics without trained HIV testing providers uniformly did not conduct HIV counseling and/or testing (0/12 [0%]), while 27/46 (59%) of clinics with ≥1 provider performed some HTC (p < 0.001). In the subset of 46 clinics with ≥1 trained HIV testing provider, correlates of performing HTC included being a public versus non-public clinic (PR 1.70 95%CI 1.01-2.88), and having an HIV comprehensive care center (CCC) onsite (PR 2.05, 95%CI 1.04-4.06). CONCLUSION: Trained HIV testing providers are crucial for FP clinics to perform any HTC. Approaches are needed to increase routine HTC in FP clinics including staffing changes and/or linkages with other testing services (in standalone VCT services or lab facilities) in order to improve the implementation of existing national guidelines. A future cluster randomized trial is planned to test an implementation strategy, the Systems Analysis and Improvement Approach (SAIA) to increase HTC in FP clinics.

Human papillomavirus vaccine delivery in Mozambique: identification of implementation performance drivers using the Consolidated Framework for Implementation Research (CFIR).

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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: Active Referral of Children of HIV-Positive Adults Reveals High Prevalence of Undiagnosed HIV.

OBJECTIVES: Few routine systems exist to test older, asymptomatic children for HIV. Testing all children in the population has high uptake but is inefficient, whereas testing only symptomatic children increases efficiency but misses opportunities to optimize outcomes. Testing children of HIV-infected adults in care may efficiently identify previously undiagnosed HIV-infected children before symptomatic disease. METHODS: HIV-infected parents in HIV care in Nairobi, Kenya were systematically asked about their children's HIV status and testing history. Adults with untested children ≤12 years old were actively referred and offered the choice of pediatric HIV testing at home or clinic. Testing uptake and HIV prevalence were determined, as were bottlenecks in pediatric HIV testing cascade. RESULTS: Of 10,426 HIV-infected adults interviewed, 8,287 reported having children, of whom 3,477 (42%) had children of unknown HIV status, and 611 (7%) had children ≤12 years of unknown HIV status. After implementation of active referral, the rate of pediatric HIV testing increased 3.8-fold from 3.5 to 13.6 children tested per month (Relative risk: 3.8, 95% confidence interval: 2.3 to 6.1). Of 611 eligible adults, 279 (48%) accepted referral and were screened, and 74 (14%) adults completed testing of 1 or more children. HIV prevalence among 108 tested children was 7.4% (95% confidence interval: 3.3 to 14.1%) and median age was 8 years (interquartile range: 2-11); 1 child was symptomatic at testing. CONCLUSIONS: Referring HIV-infected parents in care to have their children tested revealed many untested children and significantly increased the rate of pediatric testing; prevalence of HIV was high. However, despite increases in pediatric testing, most adults did not complete testing of their children.

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

BACKGROUND: Efficacious interventions to prevent mother-to-child HIV transmission (PMTCT) have not translated well into effective programs. Previous studies of systems engineering applications to PMTCT lacked comparison groups or randomization. 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. RESULTS: ARV coverage increased 3-fold [+13.3% points (95% CI: 0.5 to 26.0) in intervention vs. +4.1 (-12.6 to 20.7) in control facilities] and HEI screening increased 17-fold [+11.6 (-2.6 to 25.7) in intervention vs. +0.7 (-12.9 to 14.4) in control facilities]. In prespecified subgroup analyses, ARV coverage increased significantly in Kenya [+20.9 (-3.1 to 44.9) in intervention vs. -21.2 (-52.7 to 10.4) in controls; P = 0.02]. HEI screening increased significantly in Mozambique [+23.1 (10.3 to 35.8) in intervention vs. +3.7 (-13.1 to 20.6) in controls; P = 0.04]. HIV testing did not differ significantly between arms. CONCLUSIONS: In this first randomized trial of systems engineering to improve PMTCT, we saw substantially larger improvements in ARV coverage and HEI screening in intervention facilities compared with controls, which were significant in prespecified subgroups. Systems engineering could strengthen PMTCT service delivery and protect infants from HIV.

Patient attrition from the HIV antiretroviral therapy program at two hospitals in Haiti / Abandono del programa de tratamiento antirretrovírico de la infección por el VIH en pacientes de dos hospitales de Haití

OBJECTIVE: To identify factors associated with antiretroviral therapy (ART) attrition among patients initiating therapy in 2005-2011 at two large, public-sector department-level hospitals, and to inform interventions to improve ART retention. METHODS: This retrospective cohort study used data from the iSanté electronic medical record (EMR) system. The study characterized ART attrition levels and explored the patient demographic, clinical, temporal, and service utilization factors associated with ART attrition, using time-to-event analysis methods. RESULTS: Among the 2 023 patients in the study, ART attrition on average was 17.0 per 100 person-years (95% confidence interval (CI): 15.8-18.3). In adjusted analyses, risk of ART attrition was up to 89% higher for patients living in distant communes compared to patients living in the same commune as the hospital (hazard ratio: 1.89, 95%CI: 1.54-2.33; P < 0.001). Hospital site, earlier year of ART start, spending less time enrolled in HIV care prior to ART initiation, receiving a non-standard ART regimen, lacking counseling prior to ART initiation, and having a higher body mass index were also associated with attrition risk. CONCLUSIONS: The findings suggest quality improvement interventions at the two hospitals, including: enhanced retention support and transportation subsidies for patients accessing care from remote areas; counseling for all patients prior to ART initiation; timely outreach to patients who miss ART pick-ups; "bridging services" for patients transferring care to alternative facilities; routine screening for anticipated interruptions in future ART pick-ups; and medical case review for patients placed on non-standard ART regimens. The findings are also relevant for policymaking on decentralization of ART services in Haiti.

OBJETIVO: Determinar los factores asociados con el abandono del tratamiento antirretrovírico en los pacientes que iniciaron el tratamiento en el período del 2005 al 2011 en dos grandes hospitales públicos de nivel departamental, y fundamentar las intervenciones necesarias para mejorar la retención de los pacientes en el tratamiento. MÉTODOS: Este estudio retrospectivo de cohortes empleó los datos del sistema de registro médico electrónico iSanté. Se describieron los niveles de abandono del tratamiento y se exploraron los factores demográficos, clínicos, temporales y de utilización de los servicios que se asociaban con su abandono, usando métodos de análisis del tiempo trascurrido hasta un evento. RESULTADOS: El abandono del tratamiento entre los 2 023 pacientes incluidos en el estudio fue en promedio de 17,0 por 100 personas-años (intervalo de confianza (IC) de 95%: 15,8-18,3). En los análisis ajustados, el riesgo de abandono del tratamiento fue de hasta 89% mayor en los pacientes que vivían en comunas distantes, en comparación con los pacientes que vivían en la misma comuna en que se ubicaba el hospital (razón de riesgo: 1,89; IC de 95%: 1,54-2,33; P < 0,001). La ubicación del hospital, el inicio del tratamiento en un año calendario anterior, un menor tiempo de inclusión en el programa de atención a la infección por el VIH antes de iniciar el tratamiento, la administración de un régimen terapéutico no estándar, la falta de orientación antes de iniciar el tratamiento y un mayor índice de masa corporal también se asociaron con un riesgo más elevado de abandono. CONCLUSIONES: Los resultados sugieren algunas intervenciones de mejora de la calidad en ambos hospitales, entre ellas: un mayor apoyo a la retención y subsidios de transporte para los pacientes que acuden desde zonas remotas para ser atendidos; la orientación a todos los pacientes antes del inicio del tratamiento antirretrovírico; el contacto oportuno de los servicios con los pacientes que omiten alguna recogida de medicación; "servicios de conexión" para transferir la atención de los pacientes a otros establecimientos alternativos; el tamizaje sistemático de las interrupciones previstas en las próximas recogidas de medicación; y la revisión médica de los casos de pacientes que siguen un tratamiento no estándar. Estos hallazgos son también pertinentes en materia de formulación de políticas de descentralización de los servicios de tratamiento antirretrovírico en Haití.

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

BACKGROUND: Despite 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. METHODS: This 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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov NCT02023658.

Linkage to HIV care and antiretroviral therapy by HIV testing service type in Central Mozambique: a retrospective cohort study.

BACKGROUND: Access to antiretroviral therapy (ART) has increased dramatically in resource-limited settings since its introduction a decade ago. However, ART coverage remains low in countries with the highest disease burden, which may be partially explained by poor testing to care linkages. HIV testing service may impact early attrition in the HIV treatment cascade. METHODS: A retrospective cohort study was conducted in 18 clinics in central Mozambique using routine patient data and monthly reports. Patients referred from voluntary counseling and testing (VCT) were compared with those referred from prevention of mother-to-child transmission (PMTCT) for 3 outcomes: (1) enrollment at an HIV clinic ≤30 days after testing HIV positive, (2) CD4 test ≤30 days after enrollment, and (3) ART initiation ≤90 days after first CD4 test. RESULTS: Patient retention in the HIV care system dropped at each step from HIV testing to ART initiation. Enrollment in HIV care was not significantly different between PMTCT and VCT [risk ratio (RR) = 0.84, 0.72 < RR < 1.02]. Women tested in PMTCT were less likely to have a CD4 test ≤30 days after enrollment when adjusting for age, education level, and marital status (adjusted RR = 0.84, 0.70 < RR < 1.00), and were less likely to initiate ART ≤90 days after their first CD4 test when adjusting for age, education, and marital status (adjusted RR = 0.56, 0.44 < RR < 0.71). CONCLUSIONS: Poor linkages between HIV testing and care hamper efforts to improve coverage for HIV care and treatment services. Increased loss to follow-up among women diagnosed in PMTCT relative to VCT is worrisome and merits further qualitative research and programmatic attention.

Integration of HIV care and treatment in primary health care centers and patient retention in central Mozambique: a retrospective cohort study.

BACKGROUND: In 2004, the Mozambican Ministry of Health began a national scale-up of antiretroviral therapy (ART) using a vertical model of HIV clinics colocated within large urban hospitals. In 2006, the ministry expanded access by integrating ART into primary health care clinics. METHODS: We conducted a retrospective cohort study including adult ART-naive patients initiating ART between January 2006 and June 2008 in public sector clinics in Manica and Sofala provinces. Cox proportional hazards models with robust variances were used to estimate the association between clinic model (vertical/integrated), clinic location (urban/rural), and clinic experience (first 6 months/post first 6 months) and attrition occurring in early patient follow-up (≤ 6 months) and attrition occurring in late patient follow-up (>6 months), while controlling for age, sex, education, pre-ART CD4 count, World Health Organization stage and pharmacy staff burden. RESULTS: A total of 11,775 patients from 17 clinics were studied. The overall attrition rate was 37 per 100 person-years. Patients attending integrated clinics had a higher risk of attrition in late follow-up [hazard ratio (HR) = 1.75; 95% confidence interval (CI): 1.04 to 2.94], and patients attending urban clinics (HR = 0.57; 95% CI: 0.35 to 0.91) had a lower risk of attrition in late follow-up. Though not statistically significant, clinics open for longer than 6 months (HR = 0.71; 95% CI: 0.49 to 1.04) had a lower risk of attrition in early follow-up. CONCLUSIONS: Patients attending vertical clinics had a lower risk of attrition. Utilizing primary health clinics to implement ART is necessary to reach higher levels of coverage; however, further implementation strategies should be developed to improve patient retention in these settings.

Loss to follow-up of adults in public HIV care systems in central Mozambique: identifying obstacles to treatment.

INTRODUCTION: Access to antiretroviral treatment (ART) has expanded dramatically in resource-limited settings. Evaluating loss to follow-up from HIV testing through post-ART care can help identify obstacles to care. METHODS: Routine data were analyzed for adults receiving services in 2 public HIV care systems in central Mozambique. The proportion of people passing through the following steps was determined: (1) HIV testing, (2) enrollment at an ART clinic, (3) CD4 testing, (4) starting ART if eligible, and (5) adhering to ART. RESULTS: During the 12-month study period (2004-2005), an estimated 23,430 adults were tested for HIV and 7005 (29.9%) were HIV positive. Only 3956 (56.5%) of those HIV positive enrolled at an ART clinic < or =30 days after testing. CD4 testing was obtained in 77.1% < or =30 days of enrollment. Of 1506 eligible for ART, 471 (31.3%) started ART < or =90 days after CD4 testing. Of 382 with > or =180 days of potential follow-up time on ART, 317 (83.0%) had pharmacy-based adherence rates > or =90%. DISCUSSION: Substantial drop-offs were observed for each step between HIV testing and treatment but were highest for referral from HIV testing to treatment sites and for starting ART. Interventions are needed to improve follow-up and ensure that people benefit from available HIV services.

Scaling up antenatal syphilis screening in Mozambique: transforming policy to action.

OBJECTIVES: This paper examines the decade-long scale-up process of antenatal syphilis screening through Mozambique's National Health System. GOAL: The primary goal is to provide lessons learned in the provision of integrated antenatal care resource-poor settings and identify key challenges to successful scale-up. STUDY DESIGN: We documented health systems activities associated with improvements in the proportion of women tested, treated, and partners treated for syphilis. RESULTS: The proportion of women in antenatal visit screened for syphilis in the two target provinces has risen from 5% in 1992 to between 60% and 95% consistently since 1999. This success required multiple levels of health system strengthening. CONCLUSIONS: The Mozambique experience shows that key elements to effective antenatal syphilis screening include adequate workforce, facilities, coherent systems of care, community involvement, donor management, advocacy, and leadership.