Male involvement enhances the uptake of early infant diagnosis of HIV services in Thyolo, Malawi: A non-equivalent control group quasi-experimental study.

BACKGROUND: Poor retention of HIV-exposed infants (HEIs) in the Early Infant Diagnosis (EID) programme remains a significant challenge and impedes progress towards the elimination of Mother to Child Transmission (eMTCT). Suboptimal involvement of a father in his child's participation in the EID of HIV services is one of the reasons for delayed initiation and poor retention in EID. This study compared the uptake of EID of HIV services at 6weeks from 6 months pre and post-implementation of the Partner invitation card and Attending to couples first (PA) strategy for male involvement (MI) at Bvumbwe Health Centre in Thyolo, Malawi. METHODS: We conducted a non-equivalent control group quasi-experimental study from September 2018 to August 2019 and enrolled 204 HIV positive women with HIV exposed infants who delivered at Bvumbwe health facility. 110 women were in the period before MI in EID of HIV services from September 2018 to February 2019 whereas 94 of them were in the period of MI in EID of HIV services from March to August 2019 receiving PA strategy for MI. Using descriptive and inferential analysis we compared the two groups of women. As age, parity and education levels of women were not associated with the uptake of EID, we proceeded to calculate unadjusted odds ratio. RESULTS: We observed an increase in the proportion of women that took up EID of HIV services such that 64/94 (68.1%) came for EID of HIV services at 6weeks from 44/110 (40%) in the period before MI. The uptake of EID of HIV services had an odds ratio of 3.2(95%CI: 1.8-5.7) P = 0.001) compared to the uptake of EID of HIV services before MI OR of 0.6(95%CI: 0.46-0.98) P = 0.037). Age, parity, and education levels of women were statistically insignificant. CONCLUSION: The uptake of EID of HIV services at 6 weeks increased during the implementation of MI compared to the period before. Age, parity, and education levels of women were not associated with the EID uptake of HIV services at 6 weeks. Further studies on male involvement and uptake of EID should continue to be carried out to contribute to understanding of how high levels of EID uptake of HIV services can be achieved.

Economic evaluation of integrated services for non-communicable diseases and HIV: costs and client outcomes in rural Malawi.

OBJECTIVE: To evaluate the costs and client outcomes associated with integrating screening and treatment for non-communicable diseases (NCDs) into HIV services in a rural and remote part in southeastern Africa. DESIGN: Prospective cohort study. SETTING: Primary and secondary level health facilities in Neno District, Malawi. PARTICIPANTS: New adult enrollees in Integrated Chronic Care Clinics (IC3) between July 2016 and June 2017. MAIN OUTCOME MEASURES: We quantified the annualised total and per capita economic cost (US$2017) of integrated chronic care, using activity-based costing from a health system perspective. We also measured enrolment, retention and mortality over the same period. Furthermore, we measured clinical outcomes for HIV (viral load), hypertension (controlled blood pressure), diabetes (average blood glucose), asthma (asthma severity) and epilepsy (seizure frequency). RESULTS: The annualised total cost of providing integrated HIV and NCD care was $2 461 901 to provide care to 9471 enrollees, or $260 per capita. This compared with $2 138 907 for standalone HIV services received by 6541 individuals, or $327 per capita. Over the 12-month period, 1970 new clients were enrolled in IC3, with a retention rate of 80%. Among clients with HIV, 81% achieved an undetectable viral load within their first year of enrolment. Significant improvements were observed among clinical outcomes for clients enrolled with hypertension, asthma and epilepsy (p<0.05, in all instances), but not for diabetes (p>0.05). CONCLUSIONS: IC3 is one of the largest examples of fully integrated HIV and NCD care. Integrating screening and treatment for chronic health conditions into Malawi's HIV platform appears to be a financially feasible approach associated with several positive clinical outcomes.

Expanding access to non-communicable disease care in rural Malawi: outcomes from a retrospective cohort in an integrated NCD-HIV model.

OBJECTIVES: Non-communicable diseases (NCDs) account for one-third of disability-adjusted life years in Malawi, and access to care is exceptionally limited. Integrated services with HIV are widely recommended, but few examples exist globally. We report descriptive outcomes from an Integrated Chronic Care Clinic (IC3). DESIGN: This is a retrospective cohort study. SETTING: The study includes an HIV-NCD clinic across 14 primary care facilities in the rural district of Neno, Malawi. PARTICIPANTS: All new patients, including 6233 HIV-NCD diagnoses, enrolled between January 2015 and December 2017 were included. This included 3334 patients with HIV (59.7% women) and 2990 patients with NCD (67.3% women), 10% overall under age 15 years. INTERVENTIONS: Patients were seen at their nearest health centre, with a hospital team visiting routinely to reinforce staffing. Data were collected on paper forms and entered into an electronic medical record. PRIMARY AND SECONDARY OUTCOME MEASURES: Routine clinical measurements are reported at 1-year post-enrolment for patients with more than one visit. One-year retention is reported by diagnosis. RESULTS: NCD diagnoses were 1693 hypertension, 668 asthma, 486 epilepsy, 149 diabetes and 109 severe mental illness. By December 2018, 8.3% of patients with NCD over 15 years were also on HIV treatment. One-year retention was 85% for HIV and 72% for NCDs, with default in 8.4% and 25.5% and deaths in 4.0% and 1.4%, respectively. Clinical outcomes showed statistically significant improvement for hypertension, diabetes, asthma and epilepsy. Of the 1807 (80%) of patients with HIV with viral load results, 85% had undetectable viral load. CONCLUSIONS: The IC3 model, built on an HIV platform, facilitated rapid decentralisation and access to NCD services in rural Malawi. Clinical outcomes and retention in care are favourable, suggesting that integration of chronic disease care at the primary care level poses a way forward for the large dual burden of HIV and chronic NCDs.

The Capacity of the Fecal Microbiota From Malawian Infants to Ferment Resistant Starch.

In Low and Middle-Income Countries (LMIC), weaning is associated with environmentally acquired and inflammation-associated enteric disorders. Dietary intake of high amylose maize starch (HAMS) can promote commensal fermentative bacteria and drive the production of short chain fatty acids (SCFAs). By stabilizing commensal gut microbiology, and stimulating the production of anti-inflammatory metabolites, HAMS supplementation might therefore influence enteric health. However, the extent to which the gut microbiota of LMIC infants are capable of fermenting HAMS is unclear. We assessed the capacity of the fecal microbiota from pre-weaning and weaning Malawian infants to ferment HAMS and produce SCFAs using an in vitro fermentation model. Fecal microbiota from both pre-weaning and weaning infants were able to ferment HAMS, as indicated by an increase in bacterial load and total SCFA concentration, and a reduction in pH. All of these changes were more substantial in the weaning group. Acetate production was observed with both pre-weaning and weaning groups, while propionate production was only observed in the weaning group. HAMS fermentation resulted in significant alterations to the fecal microbial community in the weaning group, with significant increases in levels of Prevotella, Veillonella, and Collinsella associated with propionate production. In conclusion, fecal microbiota from Malawian infants before and during weaning has the capacity to produce acetate through HAMS fermentation, with propionate biosynthetic capability appearing only at weaning. Our results suggest that HAMS supplementation might provide benefit to infants during weaning.

Delivering comprehensive HIV services across the HIV care continuum: a comparative analysis of survival and progress towards 90-90-90 in rural Malawi.

INTRODUCTION: Partners In Health and the Malawi Ministry of Health collaborate on comprehensive HIV services in Neno, Malawi, featuring community health workers, interventions addressing social determinants of health and health systems strengthening. We conducted an observational study to describe the HIV care continuum in Neno and to compare facility-level HIV outcomes against health facilities nationally. METHODS: We compared facility-level outcomes in Neno (n=13) with all other districts (n=682) from 2013 to 2015 using mixed-effects linear regression modelling. We selected four outcomes that are practically useful and roughly mapped on to the 90-90-90 targets: facility-based HIV screenings relative to population, new antiretroviral therapy (ART)enrolments relative to population, 1-year survival rates and per cent retained in care at 1 year. RESULTS: In 2013, the average number of HIV tests performed, as a per cent of the adult population, was 11.75%, while the average newly enrolled patients was 10.03%. Percent receiving testing increased by 4.23% over 3 years (P<0.001, 95% CI 2.98% to 5.49%), while percent enrolled did not change (P=0.28). These results did not differ between Neno and other districts (P=0.52), despite Neno having a higher proportion of expected patients enrolled. In 2013, the average ART 1-year survival was 80.41% nationally and 91.51% in Neno, which is 11.10% higher (P=0.002, 95% CI 4.13% to 18.07%). One-year survival declined by 1.75% from 2013 to 2015 (P<0.001, 95% CI -2.61% to -0.89%); this was similar in Neno (P=0.83). Facility-level 1-year retention was 85.43% nationally in 2013 (P<0.001, 95% CI 84.2% to 86.62%) and 12.07% higher at 97.50% in Neno (P=0.001, 95% CI 5.08% to19.05%). Retention declined by 2.92% (P<0.001, 95% CI -3.69% to -2.14%) between 2013 and 2015, both nationally and in Neno. CONCLUSION: The Neno HIV programme demonstrated significantly higher survival and retention rates compared with all other districts in Malawi. Incorporating community health workers, strengthening health systems and addressing social determinants of health within the HIV programme may help Malawi and other countries accelerate progress towards 90-90-90.

Evaluating the use of pathology in improving diagnosis in rural Malawi.

Introduction: Limited data exists on histologically confirmed cancers and tuberculosis in rural Malawi, despite the high burden of both conditions. One of the main reasons for the limited data is the lack of access to pathology services for diagnosis. We reviewed histopathology results of patients in Neno District, one of the poorest rural districts in Malawi, from May 2011 to July 2017, with an emphasis on cancers and tuberculosis. Methods: This is a retrospective descriptive study reviewing pathology results of samples collected at Neno health facilities and processed at Kamiza Pathology Laboratory. Data was entered into Microsoft Excel and cleaned and analysed using Stata 14. Results: A total of 532 specimens were collected, of which 87% (465) were tissue biopsies (incision or core biopsies), and 13% (67) were cytology samples. Of all specimens, 7% (n=40) of the samples had non-diagnostic results. Among the results that were diagnostic (n=492), 37% (183) were malignancies, 33% (112) were infections and inflammatory conditions other than tuberculosis, 20% (97) were benign tumours, 7% (34) were tuberculosis, 4% (21) were pre-malignant lesions, 5% (23) were normal samples, and 4% (22) were other miscellaneous conditions. Among the malignancies (n=183), 62% (114) were from females and 38% (69) from males. Among females, almost half of the cancers were cervical (43%, n= 49), followed by Kaposi sarcoma (14%, n=16), skin cancers (9%, n=10), and breast cancer (8%, n=9). In males, Kaposi sarcoma was the most common cancer (35%, n=24), followed by skin cancers (17%, n=12). About 75% (n=137) of the cancers occurred in persons aged 15 to 60 years. Conclusion: Histopathology services at a rural hospital in Malawi provides useful diagnostic information on malignancies, tuberculosis and other diagnoses, and can inform management at the district level.

Distance to care, enrollment and loss to follow-up of HIV patients during decentralization of antiretroviral therapy in Neno District, Malawi: A retrospective cohort study.

HIV/AIDS remains the second most common cause of death in low and middle-income countries (LMICs), and only 34% of eligible patients in Africa received antiretroviral therapy (ART) in 2013. This study investigated the impact of ART decentralization on patient enrollment and retention in rural Malawi. We reviewed electronic medical records of patients registered in the Neno District ART program from August 1, 2006, when ART first became available, through December 31, 2013. We used GPS data to calculate patient-level distance to care, and examined number of annual ART visits and one-year lost to follow-up (LTFU) in HIV care. The number of ART patients in Neno increased from 48 to 3,949 over the decentralization period. Mean travel distance decreased from 7.3 km when ART was only available at the district hospital to 4.7 km when ART was decentralized to 12 primary health facilities. For patients who transferred from centralized care to nearer health facilities, mean travel distance decreased from 9.5 km to 4.7 km. Following a transfer, the proportion of patients achieving the clinic's recommended ≥4 annual visits increased from 89% to 99%. In Cox proportional hazards regression, patients living ≥8 km from a health facility had a greater hazard of being LTFU compared to patients <8 km from a facility (adjusted HR: 1.7; 95% CI: 1.5-1.9). ART decentralization in Neno District was associated with increased ART enrollment, decreased travel distance, and increased retention in care. Increasing access to ART by reducing travel distance is one strategy to achieve the ART coverage and viral suppression objectives of the 90-90-90 UNAIDS targets in rural impoverished areas.

Novel approaches to screening for noncommunicable diseases: Lessons from Neno, Malawi.

BACKGROUND: As Malawi continues to suffer from a large burden of noncommunicable diseases (NCDs), models for NCD screening need to be developed that do not overload a health system that is already heavily burdened by communicable diseases. METHODS: This descriptive study examined 3 screening programmes for NCDs in Neno, Malawi, that were implemented from June 2015 to December 2016. The NCD screening models were integrated into existing platforms, utilising regular mass screening events in the community, patients awaiting to be seen in a combined NCD and HIV clinic, and patients awaiting treatment at outpatient departments (OPDs). Focusing on hypertension and diabetes, we screened all adults 30 years and above for hypertension using a single blood pressure cut-off of 160/110 mmHg, as well as adults 40 years and above for diabetes, measuring either random blood sugar (RBS) or fasting blood sugar (FBS), with referral criteria of FBS > 126 mg/dL and RBS > 200 mg/dL. Data were collected on specifically designed screening registers, then entered and analysed in Excel. RESULTS: Over 14,000 adults (≥ 12 years old) were screened for an array of common conditions at community screening events. Of these adults, 58% (n = 8133) and 29% (n = 4016) were screened for hypertension and diabetes, respectively. Nine percent (n = 716) and 3% ( n = 113) were referred for further hypertension and diabetes assessment respectively. At one OPD, 5818 patients (60%) had their blood pressures measured, and among adults 30 years and above, 168 eligible adults were referred for further hypertension assessment. Since the initiation of the screening programmes, the number of patients ever enrolled for NCD care every 3 months has nearly tripled, from 40 to 114. CONCLUSIONS: The screening models have shown that it is not only feasible to introduce NCD screening into a public system, but screening may have also contributed to increased enrolment in NCD care in Neno, Malawi.

Impact and economic evaluation of a novel HIV service delivery model in rural Malawi.

OBJECTIVE: We performed an impact and cost-effectiveness analysis of a novel HIV service delivery model in a high prevalence, remote district of Malawi with a population of 143 800 people. DESIGN: A population-based retrospective analysis of 1-year survival rates among newly enrolled HIV-positive patients at 682 health facilities throughout Malawi, comparing facilities implementing the service delivery model (n = 13) and those implementing care-as-usual (n = 669). METHODS: Through district-level health surveillance data, we evaluated 1-year survival rates among HIV patients newly enrolled between July 2013 and June 2014 - representing 129 938 patients in care across 682 health facilities - using a multilevel modeling framework. The model, focused on social determinants of health, was implemented throughout Neno District at 13 facilities and compared with facilities in all other districts. Activity-based costing was used to annualize financial and economic costs from a societal perspective. Incremental cost-effectiveness ratios were expressed as quality-adjusted life-years gained. RESULTS: The national average 1-year survival rate for newly enrolled antiretroviral therapy clients was 78.9%: this rate was 87.9% in Neno District, compared with 78.8% across all other districts in Malawi (P < 0.001; 95% confidence interval: 0.079-0.104). The economic cost of receiving care in Neno district (n = 6541 patients) was $317/patient/year, compared with an estimated $219/patient in other districts. This translated to $906 per quality-adjusted life-year gained. CONCLUSION: Neno District's comprehensive model of care, featuring a strong focus on the community, is $98 more expensive per capita per annum but demonstrates superior 1-year survival rates, despite its remote location. Moreover, it should be considered cost-effective by traditional international standards.

Proposing the LEGS framework to complement the WHO building blocks for strengthening health systems: One needs a LEG to run an ethical, resilient system for implementing health rights.

The aim of this paper is to present a new framework to design and run a responsive and resilient health system. It can be used by both private and public, profit and non-profit organizations in order to translate strategic goals of an organization into desirable and intended best practice, and results. This includes the health sector. The framework is based on the four pillars of leadership, ethics, governance and systems, hence called LEGS framework. It can complement the six World Health Organization building blocks that guide inputs to help a health system achieve the intended goals. Despite all the strengths of the World Health Organization building blocks for health systems strengthening, it is important to highlight a few challenges: Ethics is assumed but is not explicitly stated as part of any building block. Furthermore, the World Health Organization framework lacks the flexibility to accommodate other important factors which may differ in various settings and contexts. Hence, the World Health Organization building blocks are either difficult to apply or insufficient in certain contexts, especially in countries with rampant corruption, weak rule of law and systems. This paper explores areas to strengthen the existing framework so as to achieve the intended results efficiently in different contexts. The authors propose LEGS (Leadership, Ethics, Governance and Systems Framework). This framework is very flexible, simple to use, easy to remember, accommodates the existing six WHO building blocks and can better guide different health systems and actors to achieve intended goals by taking into consideration the contextual factors like deficits in moral capital, rule of law or socioeconomic determinants of health.

Leveraging HIV platforms to work toward comprehensive primary care in rural Malawi: the Integrated Chronic Care Clinic.

This case study describes an integrated chronic care clinic that utilizes a robust HIV program as a platform for NCD screening and treatment. A unique model, the integrated chronic care clinic provides longitudinal care for patients with an array of chronic diseases including HIV and common NCDs, allowing for a single visit for all of a patient's conditions. Set in Malawi's remote Neno District, this clinic structure aims to (1) increase access to care for NCD patients, (2) maximize efficiency given the severe human resource shortages, and (3) replicate strong HIV outcomes for patients with other chronic conditions. The goal is to increase the number of health facilities in Neno capable of fully delivering Malawi's Essential Health Package, the set of cost-effective interventions endorsed by Malawi MOH to reduce burden of disease and leading causes of death. While implementation is ongoing and processes are evolving, this model of healthcare delivery has already improved the accessibility of NCD care by allowing patients to have all of their chronic conditions treated on the same day at their nearest health facility, notably without additional investment of human and financial resources. Currently, 6781 patients on antiretroviral therapy and 721 patients with NCDs are benefitting, including 379 with hypertension, 187 with asthma, 144 with epilepsy, and 76 with diabetes. Among the NCD patient population, 15.1% are HIV-positive. Success hinged largely on several factors, including clear leadership and staff ownership of their specific duties, and a well-defined and uniform patient flow process. Furthermore, deliberate and regular conversations about challenges allowed for constant iteration and improvement of processes. Moving forward, several tasks remain. We are refining the data management process to further consolidate medical records, along with integrating our tracking processes for clients who miss appointments. Additionally, we are exploring opportunities for further integration, including family planning. A follow-up patient satisfaction survey is planned for the coming months to track the impact of the clinic's redesign. Given limited human and financial resources, innovative solutions are required to address the growing burden of chronic disease in Malawi. We have found that an integrated, patient-centered approach maximizes efficiency and reduces barriers to care for the hardest to reach patients.

Excellent clinical outcomes and retention in care for adults with HIV-associated Kaposi sarcoma treated with systemic chemotherapy and integrated antiretroviral therapy in rural Malawi.

INTRODUCTION: HIV-associated Kaposi sarcoma (HIV-KS) is the most common cancer in Malawi. In 2008, the non-governmental organization, Partners In Health, and the Ministry of Health established the Neno Kaposi Sarcoma Clinic (NKSC) to treat HIV-KS in rural Neno district. We aimed to evaluate 12-month clinical outcomes and retention in care for HIV-KS patients in the NKSC, and to describe our implementation model, which featured protocol-guided chemotherapy, integrated antiretroviral therapy (ART) and psychosocial support delivered by community health workers. METHODS: We conducted a retrospective cohort study using routine clinical data from 114 adult HIV-KS patients who received ART and ≥1 chemotherapy cycle in the NKSC between March 2008 and February 2012. RESULTS: At enrolment 97% of patients (n/N=103/106) had advanced HIV-KS (stage T1). Most patients were male (n/N=85/114, 75%) with median age 36 years (interquartile range, IQR: 29-42). Patients started ART a median of 77 days prior to chemotherapy (IQR: 36-252), with 97% (n/N=105/108) receiving nevirapine/lamivudine/stavudine. Following standardized protocols, we treated 20 patients (18%) with first-line paclitaxel and 94 patients (82%) with bleomycin plus vincristine (BV). Of the 94 BV patients, 24 (26%) failed to respond to BV requiring change to second-line paclitaxel. A Division of AIDS grade 3/4 adverse event occurred in 29% of patients (n/N=30/102). Neutropenia was the most common grade 3/4 event (n/N=17/102, 17%). Twelve months after chemotherapy initiation, 83% of patients (95% CI: 74-89%) were alive, including 88 (77%) retained in care. Overall survival (OS) at 12 months did not differ by initial chemotherapy regimen (p=0.6). Among patients with T1 disease, low body mass index (BMI) (adjusted hazard ratio, aHR=4.10, 95% CI: 1.06-15.89) and 1 g/dL decrease in baseline haemoglobin (aHR=1.52, 95% CI: 1.03-2.25) were associated with increased death or loss to follow-up at 12 months. CONCLUSIONS: The NKSC model resulted in infrequent adverse events, low loss to follow-up and excellent OS. Our results suggest it is safe, effective and feasible to provide standard-of-care chemotherapy regimens from the developed world, integrated with ART, to treat HIV-KS in rural Malawi. Baseline BMI and haemoglobin may represent important patient characteristics associated with HIV-KS survival in rural sub-Saharan Africa.

Assessing and responding to palliative care needs in rural sub-Saharan Africa: results from a model intervention and situation analysis in Malawi.

INTRODUCTION: Palliative care is rarely accessible in rural sub-Saharan Africa. Partners In Health and the Malawi government established the Neno Palliative Care Program (NPCP) to provide palliative care in rural Neno district. We conducted a situation analysis to evaluate early NPCP outcomes and better understand palliative care needs, knowledge, and preferences. METHODS: Employing rapid evaluation methodology, we collected data from 3 sources: 1) chart review of all adult patients from the NPCP's first 9 months; 2) structured interviews with patients and caregivers; 3) semi-structured interviews with key stakeholders. RESULTS: The NPCP enrolled 63 patients in its first 9 months. Frequent diagnoses were cancer (n = 50, 79%) and HIV/AIDS (n = 37 of 61, 61%). Nearly all (n = 31, 84%) patients with HIV/AIDS were on antiretroviral therapy. Providers registered 112 patient encounters, including 22 (20%) home visits. Most (n = 43, 68%) patients had documented pain at baseline, of whom 23 (53%) were treated with morphine. A majority (n = 35, 56%) had ≥1 follow-up encounter. Mean African Palliative Outcome Scale pain score decreased non-significantly between baseline and follow-up (3.0 vs. 2.7, p = 0.5) for patients with baseline pain and complete pain assessment documentation. Providers referred 48 (76%) patients for psychosocial services, including community health worker support, socioeconomic assistance, or both. We interviewed 36 patients referred to the NPCP after the chart review period. Most had cancer (n = 19, 53%) or HIV/AIDS (n = 10, 28%). Patients frequently reported needing income (n = 24, 67%) or food (n = 22, 61%). Stakeholders cited a need to make integrated palliative care widely available. CONCLUSIONS: We identified a high prevalence of pain and psychosocial needs among patients with serious chronic illnesses in rural Malawi. Early NPCP results suggest that comprehensive palliative care can be provided in rural Africa by integrating disease-modifying treatment and palliative care, linking hospital, clinic, and home-based services, and providing psychosocial support that includes socioeconomic assistance.