Progression From Gestational Diabetes Mellitus to Type 2 Diabetes Mellitus Among First Nations Women in Northwest Ontario: A Retrospective Cohort Study.

OBJECTIVE: Our aim in this study was to identify the incidence of type 2 diabetes mellitus among First Nations women in northwest Ontario with a history of gestational diabetes mellitus (GDM). METHODS: This work was a retrospective cohort study of women diagnosed with GDM using a 50-gram oral glucose challenge test or a 75-gram oral glucose tolerance test from January 1, 2010, to December 31, 2017, at the Sioux Lookout Meno Ya Win Health Centre. Outcomes were assessed based on glycated hemoglobin (A1C) measurements performed between January 1, 2010, and December 31, 2019. RESULTS: The cumulative incidence of T2DM among women with a history of GDM was 18% (42 of 237) at 2 years and 39% (76 of 194) at 6 years. Women with GDM who developed T2DM were of similar age and parity and had equivalent C-section rates (26%) compared to those who did not develop T2DM. They had higher birth weights (3,866 grams vs 3,600 grams, p=0.006) and rates of treatment with insulin (24% vs 5%, p<0.001) and metformin (16% vs 5%, p=0.005). CONCLUSIONS: GDM confers a significant risk for the development of T2DM in First Nations women. Broad community-based resources, food security, and social programming are required.

Protocol for a cross-sectional study on COVID-19 vaccination programmes in primary health care.

BACKGROUND: An integrated primary health care approach, where primary care and public health efforts are coordinated, is a key feature of routine immunisation campaigns. AIM: The aim of the study is to describe the approach used by a diverse group of international primary health care professionals in delivering their coronavirus disease 2019 (COVID-19) vaccination programmes, as well as their perspectives on public health and primary care integration while implementing national COVID-19 vaccination programmes in their own jurisdictions. SETTING: This is a protocol for a study, which consists of a cross-sectional online survey disseminated among a convenience sample of international primary health care professional through member-based organisations and professional networks via email and online newsletters. METHODS: Survey development followed an iterative validation process with a formative committee developing the survey instrument based on study objectives, existing literature and best practices and a summative committee verifying and validating content. RESULTS: Main outcome measures are vaccination implementation approach (planning, coordination service deliver), level or type of primary care involvement and degree of primary care and public health integration at community level. CONCLUSION: Integrated health systems can lead to a greater impact in the rollout of the COVID-19 vaccine and can ensure that we are better prepared for crises that threaten human health, not only limited to infectious pandemics but also the rising tide of chronic disease, natural and conflict-driven disasters and climate change.Contribution: This study will provide insight and key learnings for improving vaccination efforts for COVID-19 and possible future pandemics.

Traditional Medicine and Type 2 Diabetes in First Nations Patients.

BACKGROUND: Diabetes may be a cultural experience for many First Nations patients. In this study, we explore the potential role for traditional medicine in the treatment of diabetes. METHODS: A responsive interviewing qualitative methodology was used for 10 First Nations key informant interviews. The first objective was to accurately "re-tell" participants' stories. The second was to develop an overview of traditional medicine and its role in health and diabetes management by synthesizing academic literature, pre-existing local knowledge and perspectives, and stories shared by elders and traditional healers. The traditional medicine healers gave specific permission for this study and its publication. RESULTS: There is a strong cultural and historic context for the experience of diabetes in First Nations. Political and cultural suppression, lifestyle change and ongoing social determinants of health place diabetes in a unique context and generate a sense of fatalism. Traditional medicine can facilitate individual empowerment by connecting a patient with the lessons of previous generations and traditional beliefs and practices. CONCLUSIONS: Traditional medicine can be a valuable resource for First Nations patients living with diabetes and should be considered as a therapeutic modality.

Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial.

BACKGROUND: MyDiabetesPlan is a web-based, interactive patient decision aid that facilitates patient-centred, diabetes-specific, goal-setting and shared decision-making (SDM) with interprofessional health care teams. OBJECTIVE: Assess the feasibility of (1) conducting a cluster randomized controlled trial (RCT) and (2) integrating MyDiabetesPlan into interprofessional primary care clinics. METHODS: We conducted a cluster RCT in 10 interprofessional primary care clinics with patients living with diabetes and at least two other comorbidities; half of the clinics were assigned to MyDiabetesPlan and half were assigned to usual care. To assess recruitment, retention, and resource use, we used RCT conduct logs and financial account summaries. To assess intervention fidelity, we used RCT conduct logs and website usage logs. To identify barriers and facilitators to integration of MyDiabetesPlan into clinical care across the IP team, we used audiotapes of clinical encounters in the intervention groups. RESULTS: One thousand five hundred and ninety-seven potentially eligible patients were identified through searches of electronic medical records, of which 1113 patients met the eligibility criteria upon detailed chart review. A total of 425 patients were randomly selected; of these, 213 were able to participate and were allocated (intervention: n = 102; control: n = 111), for a recruitment rate of 50.1%. One hundred and fifty-one patients completed the study, for a retention rate of 70.9%. A total of 5745 personnel-hours and $6104 CAD were attributed to recruitment and retention activities. A total of 179 appointments occurred (out of 204 expected appointments-two per participant over the 12-month study period; 87.7%). Forty (36%), 25 (23%), and 32 (29%) patients completed MyDiabetesPlan at least twice, once, and zero times, respectively. Mean time for completion of MyDiabetesPlan by the clinician and the patient during initial appointments was 37 min. From the clinical encounter transcripts, we identified diverse strategies used by clinicians and patients to integrate MyDiabetesPlan into the appointment, characterized by rapport building and individualization. Barriers to use included clinician-related, patient-related, and technical factors. CONCLUSION: An interprofessional approach to SDM using a decision aid was feasible. Lower than expected numbers of diabetes-specific appointments and use of MyDiabetesPlan were observed. Addressing facilitators and barriers identified in this study will promote more seamless integration into clinical care. Trial registration Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: February 11, 2015. Protocol version: Version 1; February 26, 2015.

Diabetes prevalence and complication rates: In individual First Nations communities in the Sioux Lookout region of Ontario.

OBJECTIVE: To test the feasibility of reporting diabetes indicators at a regional and community level in order to provide feedback to local leaders on health system performance. DESIGN: Analysis of administrative data from hospital discharges and physician billings. SETTING: Sioux Lookout region of Ontario. PARTICIPANTS: Residents from 30 remote communities served by the Sioux Lookout First Nations Health Authority. MAIN OUTCOME MEASURES: Incidence and prevalence of diabetes and incidence of diabetes complications, including heart attack, stroke, retinopathy, amputations, end-stage kidney disease, diabetes-related hospitalizations, and death. RESULTS: Data were available for 18 542 residents from the 30 remote communities. Residents were almost entirely of First Nations descent. The prevalence of diabetes was 12.9%, the annual incidence was 1.0%, and the annual rate of complications was 5.4% in 2015-2016. Prevalence increased slightly over time. We had sufficient data to report prevalence in 25 of 30 communities (average population 738; range 234 to 2626). We reported statistically significant differences in prevalence by community; 8 were above average and 2 were below average. For diabetes complications, data were pooled over 5 years, and while community-level results could be reported, the variance was too high to allow detection of significant differences. Using 2-tailed t tests for difference of proportions, we determined that grouping communities into subregions of approximately 2000 persons would permit the detection of differences of 30% from the average 5-year complication rate. CONCLUSION: This study demonstrates the possibility of reporting diabetes prevalence by individual First Nations reserve communities. Complication rates can be reported by individual community, but estimates are more useful for comparison if the smallest communities are grouped together. Such studies could be replicated across Canada to promote local use of these data for resource planning and monitoring long-term progress of diabetes programs and services.

Calling non-governmental organisations to strengthen primary health care: Lessons following Alma-Ata.

BACKGROUND: The Alma-Ata Declaration's commitment to primary health care (PHC) reaches its 40th anniversary in 2018. Over the last 40 years, the number of non-governmental organisations (NGOs) working in low-income countries (LICs) has rapidly multiplied, and over time, NGOs have both positively and negatively impacted equity, effectiveness, appropriateness and efficiency of PHC systems in LICs. AIM: The authors aim to demonstrate that at the 40th anniversary of the Alma-Ata Declaration's commitment to PHC, NGOs are particularly poised to strengthen PHC in LICs. METHODS: In this letter, the authors reflect on how NGOs have both positively and negatively impacted equity, effectiveness, appropriateness and efficiency of PHC systems based on their experience working with NGOs in LICs. RESULTS: NGOs are poised to strengthen PHC in LICs in four distinct ways: assisting with local human resources development, strengthening local information systems, enabling community-based health services and testing innovative service delivery projects. CONCLUSIONS: The authors call for NGOs to commit their expertise and resources to long-term strengthening of PHC in LICs and to critically examine the factors that prevent or assist them in this goal. As the principles of Alma-Ata are renewed, NGOs should be responsibly engaged in strengthening the declaration's goal of 'health for all'.

Effect of cardio-metabolic risk factors on all-cause mortality among HIV patients on antiretroviral therapy in Malawi: A prospective cohort study.

BACKGROUND: Cardiovascular disease (CVD) risk among people living with HIV is elevated due to persistent inflammation, hypertension and diabetes comorbidity, lifestyle factors and exposure to antiretroviral therapy (ART). Data from Africa on how CVD risk affects morbidity and mortality among ART patients are lacking. We explored the effect of CVD risk factors and the Framingham Risk Score (FRS) on medium-term ART outcomes. METHODS: A prospective cohort study of standardized ART outcomes (Dead, Alive on ART, stopped ART, Defaulted and Transferred out) was conducted from July 2014-December 2016 among patients on ART at a rural and an urban HIV clinic in Zomba district, Malawi. The primary outcome was Dead. Active defaulter tracing was not done and patients who transferred out and defaulted were excluded from the analysis. At enrolment, hypertension, diabetes and dyslipidemia were diagnosed, lifestyle data collected and the FRS was determined. Cox-regression analysis was used to determine independent risk factors for the outcome Dead. RESULTS: Of 933 patients enrolled, median age was 42 years (IQR: 35-50), 72% were female, 24% had hypertension, 4% had diabetes and 15.8% had elevated total cholesterol. The median follow up time was 2.4 years. Twenty (2.1%) patients died, 50 (5.4%) defaulted, 63 (6.8%) transferred out and 800 (85.7%) were alive on ART care (81.7% urban vs. 89.9% rural). In multivariable survival analysis, male gender (aHR = 3.28; 95%CI: 1.33-8.07, p = 0.01) and total/HDL cholesterol ratio (aHR = 5.77, 95%CI: 1.21-27.32; p = 0.03) were significantly associated with mortality. There was no significant association between mortality and hypertension, body mass index, central obesity, diabetes, FRS, physical inactivity, smoking at enrolment, ART regimen and WHO disease stage. CONCLUSIONS: Medium-term all-cause mortality among ART patients was associated with male gender and elevated total/HDL cholesterol ratio.

Dyslipidemia among rural and urban HIV patients in south-east Malawi.

BACKGROUND: While dyslipidemia importantly contributes to increased cardiovascular disease risk among patients on antiretroviral therapy (ART), data on lipid patterns among African adults on ART are limited. We describe the prevalence of lipid abnormalities and associated factors in two HIV clinics in Malawi. METHODS: We conducted a cross-sectional study in 2014 and enrolled adult patients at a rural and an urban HIV clinic in Zomba district, Malawi. We recorded patient characteristics, CVD risk factors and anthropometric measurements, using the WHO STEPS validated instrument. Non-fasting samples were taken for determination of total cholesterol (TC), triglyceride (TG) and HDL-cholesterol (HDL-c) levels. Logistic regression analysis was used to determine factors associated with elevated TC and elevated TC/HDL-c ratio. RESULTS: 554 patients were enrolled, 50% at the rural HIV clinic, 72.7% were female, the median (IQR) age was 42 years (36-50); 97.3% were on ART, 84.4% on tenofovir/lamivudine/efavirenz, 17.5% were overweight/obese and 27.8%% had elevated waist/hip ratio. 15.5% had elevated TC, 15.9% reduced HDL-c, 28.7% had elevated TG and 3.8% had elevated TC/HDL-c ratio. Lipid abnormalities were similar in rural and urban patients. Women had significantly higher burden of elevated TC and TG whereas men had higher prevalence of reduced HDL-c. Waist-to-hip ratio was independently associated with elevated TC (aOR = 1.90; 95% CI: 1.17-3.10, p = 0.01) and elevated TC/HDL-c ratio (aOR = 3.50; 95% CI: 1.38-8.85, p = 0.008). Increasing age was independently associated with elevated TC level (aOR = 1.54, 95% CI 0.51-4.59 for age 31-45; aOR = 3.69, 95% CI 1.24-10.95 for age >45 years vs. ≤30 years; p-trend <0.01). CONCLUSIONS: We found a moderate burden of dyslipidemia among Malawian adults on ART, which was similar in rural and urban patients but differed significantly between men and women. High waist-hip ratio predicted elevated TC and elevated TC/HDL-c ratio and may be a practical tool for CVD risk indication in resource limited settings.

Greater retention in care among adolescents on antiretroviral treatment accessing "Teen Club" an adolescent-centred differentiated care model compared with standard of care: a nested case-control study at a tertiary referral hospital in Malawi.

INTRODUCTION: There are numerous barriers to the care and support of adolescents living with HIV (ALHIV) that makes this population particularly vulnerable to attrition from care, poor adherence and virological failure. In 2010, a Teen Club was established in Zomba Central Hospital (ZCH), Malawi, a tertiary referral HIV clinic. Teen Club provides ALHIV on antiretroviral treatment (ART) with dedicated clinic time, sexual and reproductive health education, peer mentorship, ART refill and support for positive living and treatment adherence. The purpose of this study was to evaluate whether attending Teen Club improves retention in ART care. METHODS: We conducted a nested case-control study with stratified selection, using programmatic data from 2004 to 2015. Cases (ALHIV not retained in care) and controls (ALHIV retained in care) were matched by ART initiation age group. Patient records were reviewed retrospectively and subjects were followed starting in March 2010, the month in which Teen Club was opened. Follow-up ended at the time patients were no longer considered retained in care or on 31 December 2015. Cases and controls were drawn from a study population of 617 ALHIV. Of those, 302 (48.9%) participated in at least two Teen Club sessions. From the study population, 135 (non-retained) cases and 405 (retained) controls were selected. RESULTS: In multivariable analyses, Teen Club exposure, age at the time of selection and year of ART initiation were independently associated with attrition. ALHIV with no Teen Club exposure were less likely to be retained than those with Teen Club exposure (adjusted odds ratio (aOR) 0.27; 95% CI 0.16, 0.45) when adjusted for sex, ART initiation age, current age, reason for ART initiation and year of ART initiation. ALHIV in the age group 15 to 19 were more likely to have attrition from care than ALHIV in the age group 10 to 14 years of age (aOR 2.14; 95% CI 1.12, 4.11). CONCLUSIONS: This study contributes to the limited evidence evaluating the effectiveness of service delivery interventions to support ALHIV within healthcare settings. Prospective evaluation of the Teen Club package with higher methodological quality is required for programmes and governments in low- and middle-income settings to prioritize interventions for ALHIV and determine their cost-effectiveness.

A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression.

STUDY DESIGN: Guideline development. OBJECTIVES: The objective of this study is to develop guidelines that outline how to best manage (1) patients with mild, moderate, and severe myelopathy and (2) nonmyelopathic patients with evidence of cord compression with or without clinical symptoms of radiculopathy. METHODS: Five systematic reviews of the literature were conducted to synthesize evidence on disease natural history; risk factors of disease progression; the efficacy, effectiveness, and safety of nonoperative and surgical management; the impact of preoperative duration of symptoms and myelopathy severity on treatment outcomes; and the frequency, timing, and predictors of symptom development. A multidisciplinary guideline development group used this information, and their clinical expertise, to develop recommendations for the management of degenerative cervical myelopathy (DCM). RESULTS: Our recommendations were as follows: (1) "We recommend surgical intervention for patients with moderate and severe DCM." (2) "We suggest offering surgical intervention or a supervised trial of structured rehabilitation for patients with mild DCM. If initial nonoperative management is pursued, we recommend operative intervention if there is neurological deterioration and suggest operative intervention if the patient fails to improve." (3) "We suggest not offering prophylactic surgery for non-myelopathic patients with evidence of cervical cord compression without signs or symptoms of radiculopathy. We suggest that these patients be counseled as to potential risks of progression, educated about relevant signs and symptoms of myelopathy, and be followed clinically." (4) "Non-myelopathic patients with cord compression and clinical evidence of radiculopathy with or without electrophysiological confirmation are at a higher risk of developing myelopathy and should be counselled about this risk. We suggest offering either surgical intervention or nonoperative treatment consisting of close serial follow-up or a supervised trial of structured rehabilitation. In the event of myelopathic development, the patient should be managed according to the recommendations above." CONCLUSIONS: These guidelines will promote standardization of care for patients with DCM, decrease the heterogeneity of management strategies and encourage clinicians to make evidence-informed decisions.

Differences in survival among adults with HIV-associated Kaposi's sarcoma during routine HIV treatment initiation in Zomba district, Malawi: a retrospective cohort analysis.

Background: The HIV epidemic is a major public health concern throughout Africa. Malawi is one of the worst affected countries in sub-Saharan Africa with a 2014 national HIV prevalence currently estimated at 10% (9.3-10.8%) by UNAIDS. Study reports, largely in the African setting comparing outcomes in HIV patients with and without Kaposi's sarcoma (KS) indicate poor prognosis and poor health outcomes amongst HIV+KS patients. Understanding the mortality risk in this patient group could help improve patient management and care. Methods: Using data for the 559 adult HIV+KS patients who started ART between 2004 and September 2011 at Zomba clinic in Malawi, we estimated relative hazard ratios for all-cause mortality by controlling for age, sex, TB status, occupation, date of starting treatment and distance to the HIV+KS clinic. Results: Patients with tuberculosis (95% CI: 1.05-4.65) and patients who started ART before 2008 (95% CI: 0.34-0.81) were at significantly greater risk of dying. A random-effects Cox model with Log-Gaussian frailties adequately described the variation in the hazard for mortality. Conclusion: The year of starting ART and TB status significantly affected survival among HIV+KS patients. A sub-population analysis of this kind can inform an efficient triage system for managing vulnerable patients.

Effectiveness of advertising availability of prenatal ultrasound on uptake of antenatal care in rural Uganda: A cluster randomized trial.

In rural Uganda pregnant women often lack access to health services, do not attend antenatal care, and tend to utilize traditional healers/birth attendants. We hypothesized that receiving a message advertising that "you will be able to see your baby by ultrasound" would motivate rural Ugandan women who otherwise might use a traditional birth attendant to attend antenatal care, and that those women would subsequently be more satisfied with care. A cluster randomized trial was conducted across eight rural sub-counties in southwestern Uganda. Sub-counties were randomized to a control arm, with advertisement of antenatal care with no mention of portable obstetric ultrasound (four communities, n = 59), or an intervention arm, with advertisement of portable obstetric ultrasound. Advertisement of portable obstetric ultrasound was further divided into intervention A) word of mouth advertisement of portable obstetric ultrasound and antenatal care (one communitity, n = 16), B) radio advertisement of only antenatal care and word of mouth advertisement of antenatal care and portable obstetric ultrasound (one community, n = 7), or C) word of mouth + radio advertisement of both antenatal care and portable obstetric ultrasound (two communities, n = 75). The primary outcome was attendance to antenatal care. 159 women presented to antenatal care across eight sub-counties. The rate of attendance was 65.1 (per 1000 pregnant women, 95% CI 38.3-110.4) where portable obstetric ultrasound was advertised by radio and word of mouth, as compared to a rate of 11.1 (95% CI 6.1-20.1) in control communities (rate ratio 5.9, 95% CI 2.6-13.0, p<0.0001). Attendance was also improved in women who had previously seen a traditional healer (13.0, 95% CI 5.4-31.2) compared to control (1.5, 95% CI 0.5-5.0, rate ratio 8.7, 95% CI 2.0-38.1, p = 0.004). By advertising antenatal care and portable obstetric ultrasound by radio attendance was significantly improved. This study suggests that women can be motivated to attend antenatal care when offered the concrete incentive of seeing their baby.

A systematic review of primary care models for non-communicable disease interventions in Sub-Saharan Africa.

BACKGROUND: Chronic diseases, primarily cardiovascular disease, respiratory disease, diabetes and cancer, are the leading cause of death and disability worldwide. In sub-Saharan Africa (SSA), where communicable disease prevalence still outweighs that of non-communicable disease (NCDs), rates of NCDs are rapidly rising and evidence for primary healthcare approaches for these emerging NCDs is needed. METHODS: A systematic review and evidence synthesis of primary care approaches for chronic disease in SSA. Quantitative and qualitative primary research studies were included that focused on priority NCDs interventions. The method used was best-fit framework synthesis. RESULTS: Three conceptual models of care for NCDs in low- and middle-income countries were identified and used to develop an a priori framework for the synthesis. The literature search for relevant primary research studies generated 3759 unique citations of which 12 satisfied the inclusion criteria. Eleven studies were quantitative and one used mixed methods. Three higher-level themes of screening, prevention and management of disease were derived. This synthesis permitted the development of a new evidence-based conceptual model of care for priority NCDs in SSA. CONCLUSIONS: For this review there was a near-consensus that passive rather than active case-finding approaches are suitable in resource-poor settings. Modifying risk factors among existing patients through advice on diet and lifestyle was a common element of healthcare approaches. The priorities for disease management in primary care were identified as: availability of essential diagnostic tools and medications at local primary healthcare clinics and the use of standardized protocols for diagnosis, treatment, monitoring and referral to specialist care.

The burden of hypertension, diabetes mellitus, and cardiovascular risk factors among adult Malawians in HIV care: consequences for integrated services.

BACKGROUND: Hypertension and diabetes prevalence is high in Africans. Data from HIV infected populations are limited, especially from Malawi. Integrating care for chronic non-communicable co-morbidities in well-established HIV services may provide benefit for patients by preventing multiple hospital visits but will increase the burden of care for busy HIV clinics. METHODS: Cross-sectional study of adults (≥18 years) at an urban and a rural HIV clinic in Zomba district, Malawi, during 2014. Hypertension and diabetes were diagnosed according to stringent criteria. Proteinuria, non-fasting lipids and cardio/cerebro-vascular disease (CVD) risk scores (Framingham and World Health Organization/International Society for Hypertension) were determined. The association of patient characteristics with diagnoses of hypertension and diabetes was studied using multivariable analyses. We explored the additional burden of care for integrated drug treatment of hypertension and diabetes in HIV clinics. We defined that burden as patients with diabetes and/or stage II and III hypertension, but not with stage I hypertension unless they had proteinuria, previous stroke or high Framingham CVD risk. RESULTS: Nine hundred fifty-two patients were enrolled, 71.7% female, median age 43.0 years, 95.9% on antiretroviral therapy (ART), median duration 47.7 months. Rural and urban patients' characteristics differed substantially. Hypertension prevalence was 23.7% (95%-confidence interval 21.1-26.6; rural 21.0% vs. urban 26.5%; p = 0.047), of whom 59.9% had stage I (mild) hypertension. Diabetes prevalence was 4.1% (95%-confidence interval 3.0-5.6) without significant difference between rural and urban settings. Prevalence of proteinuria, elevated total/high-density lipoprotein-cholesterol ratio and high CVD risk score was low. Hypertension diagnosis was associated with increasing age, higher body mass index, presence of proteinuria, being on regimen zidovudine/lamivudine/nevirapine and inversely with World Health Organization clinical stage at ART initiation. Diabetes diagnosis was associated with higher age and being on non-standard first-line or second-line ART regimens. CONCLUSION: Among patients in HIV care 26.6% had hypertension and/or diabetes. Close to two-thirds of hypertension diagnoses was stage I and of those few had an indication for antihypertensive pharmacotherapy. According to our criteria, 13.0% of HIV patients in care required drug treatment for hypertension and/or diabetes.

Trends in ART Initiation among Men and Non-Pregnant/Non-Breastfeeding Women before and after Option B+ in Southern Malawi.

BACKGROUND: Option B+ is promoted as a key component to eliminating vertical transmission of HIV; however, little is known about the policy's impact on non-targeted populations, such as men and non-pregnant/non-breastfeeding women. We compare ART uptake among non-targeted populations during pre/post Option B+ periods in Zomba District, Malawi. METHODS: Individual-level ART registry data from 27 health facilities were digitized and new ART initiates were disaggregated by sex and type of initiate (Option B+ or not). Data were analyzed over the pre- (January 2009-June 2011) and post- (July 2011- December 2013) Option B+ periods. RESULTS: After the implementation of Option B+, the total number of new female initiates increased significantly (quarterly median: 547 vs. 816; P = 0.001) and their median age decreased from 34 to 31 years (P = <0.001). Both changes were the result of the rapid and sustained uptake of ART among Option B+ clients. Post-policy, Option B+ clients represented 48% of all new female initiates while the number of females who initiated through CD4 or WHO staging criteria significantly decreased (quarterly median: 547 vs. 419; P = 0.005). The number and age of male initiates remained stable; however, the proportion of men among new initiates decreased (36% vs. 31%; P = <0.001). CONCLUSIONS: Option B+ shifted the profile of first-time initiates towards younger and fertile women. Declines among non-Option B+ women most likely reflect earlier initiation during pregnancies before deteriorations in health. The decreased proportion of men among first-time initiates represents a growing gender disparity in HIV services that deserves immediate attention.

Shifting human resources for health in the context of ART provision: qualitative and quantitative findings from the Lablite baseline study.

BACKGROUND: Lablite is an implementation project supporting and studying decentralized antiretroviral therapy (ART) rollout to rural communities in Malawi, Uganda and Zimbabwe. Task shifting is one of the strategies to deal with shortage of health care workers (HCWs) in ART provision. Evaluating Human Resources for Health (HRH) optimization is essential for ensuring access to ART. The Lablite project started with a baseline survey whose aim was to describe and compare national and intercountry delivery of ART services including training, use of laboratories and clinical care. METHODS: A cross-sectional survey was conducted between October 2011 and August 2012 in a sample of 81 health facilities representing different regions, facility levels and experience of ART provision in Malawi, Uganda and Zimbabwe. Using a questionnaire, data were collected on facility characteristics, human resources and service provision. Thirty three (33) focus group discussions were conducted with HCWs in a subset of facilities in Malawi and Zimbabwe. RESULTS: The survey results showed that in Malawi and Uganda, primary care facilities were run by non-physician clinical officers/medical assistants while in Zimbabwe, they were run by nurses/midwives. Across the three countries, turnover of staff was high especially among nurses. Between 10 and 20% of the facilities had at least one clinical officer/medical assistant leave in the 3 months prior to the study. Qualitative results show that HCWs in ART and non-ART facilities perceived a shortage of staff for all services, even prior to the introduction of ART provision. HCWs perceived the introduction of ART as having increased workload. In Malawi, the number of people on ART and hence the workload for HCWs has further increased following the introduction of Option B+ (ART initiation and life-long treatment for HIV positive pregnant and lactating women), resulting in extended working times and concerns that the quality of services have been affected. For some HCWs, perceived low salaries, extended working schedules, lack of training opportunities and inadequate infrastructure for service provision were linked to low job satisfaction and motivation. CONCLUSIONS: ART has been decentralized to lower level facilities in the context of an ongoing HRH crisis and staff shortage, which may compromise the provision of high-quality ART services. Task shifting interventions need adequate resources, relevant training opportunities, and innovative strategies to optimize the operationalization of new WHO treatment guidelines which continue to expand the number of people eligible for ART.

Survival Outcomes in a Pediatric Antiretroviral Treatment Cohort in Southern Malawi.

BACKGROUND: Pediatric uptake and outcomes in antiretroviral treatment (ART) programmes have lagged behind adult programmes. We describe outcomes from a population-based pediatric ART cohort in rural southern Malawi. METHODS: Data were analyzed on children who initiated ART from October/2003 -September/2011. Demographics and diagnoses were described and survival analyses conducted to assess the impact of age, presenting features at enrolment, and drug selection. RESULTS: The cohort consisted of 2203 children <15 years of age. Age at entry was <1 year for 219 (10%), 1-1.9 years for 343 (16%), 2-4.9 years for 584 (27%), and 5-15 years for 1057 (48%) patients. Initial clinical diagnoses of tuberculosis and wasting were documented for 409 (19%) and 523 (24%) patients, respectively. Median follow-up time was 1.5 years (range 0-8 years), with 3900 patient-years of follow-up. Over the period of observation, 134 patients (6%) died, 1324 (60%) remained in the cohort, 345 (16%) transferred out, and 387 (18%) defaulted. Infants <1 year of age accounted for 19% of deaths, with a 2.7-fold adjusted mortality hazard ratio relative to 5-15 year olds; median time to death was also shorter for infants (60 days) than older children (108 days). Survival analysis demonstrated younger age at ART initiation, more advanced HIV stage, and presence of tuberculosis to each be associated with shorter survival time. Among children <5 years, severe wasting (weight-for-height z-score

Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict--study protocol for a randomized controlled trial.

BACKGROUND: Competing health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care. METHODS/DESIGN: A two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit's impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data. DISCUSSION: An individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.

Supporting middle-cadre health care workers in Malawi: lessons learned during implementation of the PALM PLUS package.

BACKGROUND: The government of Malawi is committed to the broad rollout of antiretroviral treatment in Malawi in the public health sector; however one of the primary challenges has been the shortage of trained health care workers. The Practical Approach to Lung Health Plus HIV/AIDS in Malawi (PALM PLUS) package is an innovative guideline and training intervention that supports primary care middle-cadre health care workers to provide front-line integrated primary care. The purpose of this paper is to describe the lessons learned in implementing the PALM PLUS package. METHODS: A clinical tool, based on algorithm- and symptom-based guidelines was adapted to the Malawian context. An accompanying training program based on educational outreach principles was developed and a cascade training approach was used for implementation of the PALM PLUS package in 30 health centres, targeting clinical officers, medical assistants, and nurses. Lessons learned were identified during program implementation through engagement with collaborating partners and program participants and review of program evaluation findings. RESULTS: Key lessons learned for successful program implementation of the PALM PLUS package include the importance of building networks for peer-based support, ensuring adequate training capacity, making linkages with continuing professional development accreditation and providing modest in-service training budgets. The main limiting factors to implementation were turnover of staff and desire for financial training allowances. CONCLUSIONS: The PALM PLUS approach is a potential model for supporting mid-level health care workers to provide front-line integrated primary care in low and middle income countries, and may be useful for future task-shifting initiatives.

The Lablite project: a cross-sectional mapping survey of decentralized HIV service provision in Malawi, Uganda and Zimbabwe.

BACKGROUND: In sub-Saharan Africa antiretroviral therapy (ART) is being decentralized from tertiary/secondary care facilities to primary care. The Lablite project supports effective decentralization in 3 countries. It began with a cross-sectional survey to describe HIV and ART services. METHODS: 81 purposively sampled health facilities in Malawi, Uganda and Zimbabwe were surveyed. RESULTS: The lowest level primary health centres comprised 16/20, 21/39 and 16/22 facilities included in Malawi, Uganda and Zimbabwe respectively. In Malawi and Uganda most primary health facilities had at least 1 medical assistant/clinical officer, with average 2.5 and 4 nurses/midwives for median catchment populations of 29,275 and 9,000 respectively. Primary health facilities in Zimbabwe were run by nurses/midwives, with average 6 for a median catchment population of 8,616. All primary health facilities provided HIV testing and counselling, 50/53 (94%) cotrimoxazole preventive therapy (CPT), 52/53 (98%) prevention of mother-to-child transmission of HIV (PMTCT) and 30/53 (57%) ART management (1/30 post ART-initiation follow-up only). All secondary and tertiary-level facilities provided HIV and ART services. In total, 58/81 had ART provision. Stock-outs during the 3 months prior to survey occurred across facility levels for HIV test-kits in 55%, 26% and 9% facilities in Malawi, Uganda and Zimbabwe respectively; for CPT in 58%, 32% and 9% and for PMTCT drugs in 26%, 10% and 0% of facilities (excluding facilities where patients were referred out for either drug). Across all countries, in facilities with ART stored on-site, adult ART stock-outs were reported in 3/44 (7%) facilities compared with 10/43 (23%) facility stock-outs of paediatric ART. Laboratory services at primary health facilities were limited: CD4 was used for ART initiation in 4/9, 5/6 and 13/14 in Malawi, Uganda and Zimbabwe respectively, but frequently only in selected patients. Routine viral load monitoring was not used; 6/58 (10%) facilities with ART provision accessed centralised viral loads for selected patients. CONCLUSIONS: Although coverage of HIV testing, PMTCT and cotrimoxazole prophylaxis was high in all countries, decentralization of ART services was variable and incomplete. Challenges of staffing and stock management were evident. Laboratory testing for toxicity and treatment effectiveness monitoring was not available in most primary level facilities.