Decentralization and Integration of Advanced Cardiac Care for the World's Poorest Billion Through the PEN-Plus Strategy for Severe Chronic Non-Communicable Disease.

Rheumatic and congenital heart disease, cardiomyopathies, and hypertensive heart disease are major causes of suffering and death in low- and lower middle-income countries (LLMICs), where the world's poorest billion people reside. Advanced cardiac care in these counties is still predominantly provided by specialists at urban tertiary centers, and is largely inaccessible to the rural poor. This situation is due to critical shortages in diagnostics, medications, and trained healthcare workers. The Package of Essential NCD Interventions - Plus (PEN-Plus) is an integrated care model for severe chronic noncommunicable diseases (NCDs) that aims to decentralize services and increase access. PEN-Plus strategies are being initiated by a growing number of LLMICs. We describe how PEN-Plus addresses the need for advanced cardiac care and discuss how a global group of cardiac organizations are working through the PEN-Plus Cardiac expert group to promote a shared operational strategy for management of severe cardiac disease in high-poverty settings.

Supporting re-engagement with HIV services after treatment interruption in South Africa: a mixed method program evaluation of MSF's Welcome Service.

Psychosocial challenges impact patients' ability to remain on antiretroviral therapy lifelong, magnified by disorganized health-systems and healthcare worker (HCW) attitudes. To address this, Médecins Sans Frontières and the Department of Health developed the Welcome Service intervention, to provide person-centered care at re-engagement after HIV treatment interruption. Implemented in Khayelitsha, South Africa, between August 2020 and February 2021, the intervention aimed to reorganize triage, optimize clinical and counselling services and address HCW attitudes. The study used a mixed-methods design, incorporating in-depth interviews, and analyses of programmatic and routine health data. Interviews demonstrated positive patient care experiences. HCWs understood the potential impact of attitudes on patient engagement, however, some continued to demonstrate judgmental attitude. Clinical objectives were variably met at re-engagement: 98% were re-initiated the same day, 50% had a CD4 done, and 45% received tuberculosis prevention. Nevertheless, 4-month retention was 66%, and 88% had a VL < 1000 c/mL. Despite HCWs' understanding of person-centered care not translating into supportive behaviors, patients had positive care experiences and the intervention ended with a high rate of VL suppression. More efforts are needed to design interventions building on Welcome Service principles to provide person-centered care and sustain retention after re-engagement.

Tuberculosis Diagnosis and Preventive Monotherapy Among Children and Adolescents Exposed to Rifampicin-Resistant Tuberculosis in the Household.

Background: Children and adolescents with household exposure to multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB) are at high risk of developing TB disease. Tuberculosis preventive therapy (TPT) is recommended, but programmatic experience is limited, particularly for adolescents. Methods: We conducted a prospective cohort study to describe MDR/RR-TB diagnosis and TPT provision for individuals aged <18 years with MDR/RR-TB exposure. Participants were assessed for TB either in homes or health facilities, with referral for chest x-ray or specimen collection at clinician discretion. The TPT regimens included levofloxacin, isoniazid, or delamanid monotherapy for 6 months, based on source patient drug-resistance profile. Results: Between March 1, 2020 and July 31, 2021, 112 participants were enrolled; median age was 8.5 years, 57 (51%) were female, and 6 (5%) had human immunodeficiency virus. On screening, 11 (10%) were diagnosed with TB: 10 presumptive MDR/RR-TB and 1 drug-susceptible TB. Overall, 95 (94% of 101) participants started TPT: 79 with levofloxacin, 9 with isoniazid, and 7 with delamanid. Seventy-six (80%) completed TPT, 12 (13%) were lost to follow up, and 7 (7%) stopped TPT early due to adverse events. Potential adverse events were reported for 12 (13%) participants; none were serious. There were no further TB diagnoses (200 days median follow up). Conclusions: Post-MDR/RR-TB exposure management for children and adolescents resulted in significant MDR/RR-TB detection and both high TPT initiation and completion. Tuberculosis preventive monotherapy was well tolerated and there were no further TB diagnoses after initial assessment. Key factors supporting these outcomes included use of pediatric formulations for young children, monotherapy, and community-based options for assessment and follow up.

Delivering PrEP to Young Women in a Low-Income Setting in South Africa: Lessons for Providing Both Convenience and Support.

Daily oral pre-exposure prophylaxis (PrEP) is a key tool in addressing high HIV incidence among young women, and breaking the cycle of transmission. From 2017 to 2020, Médecins Sans Frontières (MSF) offered PrEP, in conjunction with contraception and risk-reduction counselling, to women aged 18-25, in a government-run clinic in Khayelitsha, a low income high HIV prevalence area in South Africa. Drawing on clinical, quantitative, and qualitative interview data, we describe participants' experiences and engagement with the PrEP program, participant adherence (measured by TFV-DP levels in dried blood spots) over time, and the indirect benefits of the PrEP program. Of 224 screened and eligible participants, 164 (73.2%) initiated PrEP, with no large differences between those who initiated and those who did not. Overall, 47 (29%) completed 18 months follow-up, with 15 (9.1%) attending all visits. 76 (46.9%) participants were lost to follow-up, 15 (9.1%) exited when leaving the area, and 28.7% of exits happened in the first month of the study. We identified two different trajectories of PrEP adherence: 67% of participants had, on average, consistently low TFV-DP levels, with the remaining 33% having sustained high adherence. Few baseline characteristics predicted good adherence. The main reported barrier to taking PrEP was forgetting to take or travel with the pills. Encouragement from others declined as a reported facilitator from month 6 to 18 (family: 93.1% vs 77.6%, p = 0.016, friends: 77.6% vs 41.4%, p ≤ 0.001, partners: 62.1% vs 46.6%, p = 0.096, other PrEP users: 89.7% vs 74.1%, p = 0.020). Disclosure to friends and family in some cases opened dialogue around sex, and helped to educate others about PrEP. Self-reported sex with more than one partner, and sex without a condom, decreased significantly after enrolment (p < 0.001, p = 0.063). In the individual interviews, participants credited their PrEP experience with changing their behaviour. Recognising the challenges with, but overall benefits from a package of care that includes the option of PrEP, lessons drawn from this study can help maximise persistence on PrEP within resource constraints. PrEP providers need to address participants' need for both convenience and social support.

Decentralising diabetes care from hospitals to primary health care centres in Malawi.

BACKGROUND: Non-communicable diseases (NCDs) such as diabetes and hypertension have become a prominent public health concern in Malawi, where health care services for NCDs are generally restricted to urban centres and district hospitals, while the vast majority of Malawians live in rural settings. Whether similar quality of diabetes care can be delivered at health centres compared to hospitals is not known. METHODS: We implemented a pilot project of decentralized diabetes care at eight health centres in four districts in Malawi. We described differences between district hospitals and rural health centres in terms of patient characteristics, diabetes complications, cardiovascular risk factors, and aspects of the quality of care and used multivariate logistic regression to explore factors associated with adequate diabetes and blood pressure control. RESULTS: By March 2019, 1339 patients with diabetes were registered of whom 286 (21%) received care at peripheral health centres. The median duration of care of patients in the diabetes clinics during the study period was 8.8 months. Overall, HIV testing coverage was 93.6%, blood pressure was recorded in 92.4%; 68.5% underwent foot examination of whom 35.0% had diabetic complications; 30.1% underwent fundoscopy of whom 15.6% had signs of diabetic retinopathy. No significant differences in coverage of testing for diabetes complications were observed between health facility types. Neither did we find significant differences in retention in care (72.1 vs. 77.6%; p=0.06), adequate diabetes control (35.0% vs. 37.8%; p=0.41) and adequate blood pressure control (51.3% vs. 49.8%; p=0.66) between hospitals and health centres. In multivariate analysis, male sex was associated with adequate diabetes control, while lower age and normal body mass index were associated with adequate blood pressure control; health facility type was not associated with either. CONCLUSION: Quality of care did not appear to differ between hospitals and health centres, but was insufficient at both levels.

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.

Early experiences integrating hypertension and diabetes screening and treatment in a human immunodeficiency virus clinic in Malawi.

Background: Human immunodeficiency virus (HIV) programmes can be leveraged to manage the growing burden of non-communicable diseases (NCDs). Methods: In October 2015, a model of integrated HIV-NCD care was developed at a large HIV clinic in southeast Malawi. Blood pressure was measured in adults at every visit and random blood glucose was determined every 2 y. Uncomplicated antiretroviral therapy (ART)-only care was provided by nurses, integrated HIV-NCD management was provided by clinical officers. Waiting times were assessed using the electronic medical record system. The team met monthly to identify bottlenecks. Results: All (n=6036) adult HIV patients were screened and 765 were diagnosed with hypertension (prevalence 12.7% [95% confidence interval {CI} 11.9-13.5). A total of 2979 adult HIV patients were screened and 25 were diagnosed with diabetes mellitus (prevalence 0.8% [95% CI 0.6-1.2]). The mean duration of ART visits by clinical officers increased from 80.5 to 90 min during the first quarter following HIV-NCD integration but returned to 75 min the following quarter. The mean number of patients seen per day by clinical officers increased from 6 to 11 and for nurses decreased from 92 to 82 in that time period. The robust vertical HIV system made the design of integrated tools demanding. Challenges of integrated HIV-NCD care were related to patient flow, waiting times, NCD drug availability, data collection, clinic workload and the timing of diabetes and hypertension screening. Conclusions: Integrated HIV-NCD services provision was feasible in our clinic.

Models of integration of HIV and noncommunicable disease care in sub-Saharan Africa: lessons learned and evidence gaps.

OBJECTIVE: To describe available models of HIV and noncommunicable disease (NCD) care integration in sub-Saharan Africa (SSA). DESIGN: Narrative review of published articles describing various models of HIV and NCD care integration in SSA. RESULTS: We identified five models of care integration across various SSA countries. These were integrated community-based screening for HIV and NCDs in the general population; screening for NCDs and NCD risk factors among HIV patients enrolled in care; integration of HIV and NCD care within clinics; differentiated care for patients with HIV and/or NCDs; and population healthcare for all. We illustrated these models with descriptive case studies highlighting the lessons learned and evidence gaps from the various models. CONCLUSION: Leveraging existing HIV infrastructure for NCD care is feasible with various approaches possible depending on available program capacity. Process and clinical outcomes for existing models of care integration are not yet described but are urgently required to further advise policy decisions on HIV/NCD care integration.

Early experiences in integrating cervical cancer screening and treatment into HIV services in Zomba Central Hospital, Malawi.

Background: Malawi has the highest rate of cervical cancer globally and cervical cancer is six to eight times more common in women with HIV. HIV programmes provide an ideal setting to integrate cervical cancer screening. Methods: Tisungane HIV clinic at Zomba Central Hospital has around 3,700 adult women receiving treatment. In October 2015, a model of integrated cervical cancer screening using visual inspection with acetic acid (VIA) was adopted. All women aged 20 and above in the HIV clinic were asked if they had cervical cancer screening in the past three years and, if not, were referred for screening. Screening was done daily by nurses in a room adjacent to the HIV clinic. Cold coagulation was used to treat pre-cancerous lesions. From October 2016, a modification to the HIV programme's electronic medical record was developed that assisted in matching numbers of women sent for screening with daily screening capacity and alerted providers to women with pre-cancerous lesions who missed referrals or treatment. Results: Between May 2016 and March 2017, cervical cancer screening was performed in 957 women from the HIV clinic. Of the 686 (71%) women who underwent first ever screening, 23 (3.4%) were found to have VIA positive lesions suggestive of pre-cancer, of whom 8 (35%) had a same-day cold coagulation procedure, seven (30%) deferred cold coagulation to a later date (of whom 4 came for treatment), and 8 (35%) were referred to surgery due to size of lesion; 5/686 (0.7%) women had lesions suspicious of cancer. Conclusion: Incorporating cervical cancer screening into services at HIV clinics is feasible. A structured approach to screening in the HIV clinic was important.

You can treat my HIV - But can you treat my blood pressure? Availability of integrated HIV and non-communicable disease care in northern Malawi.

BACKGROUND: Many patients on antiretroviral therapy (ART) in Malawi have or will develop non-communicable diseases (NCDs). The current capacity of ART sites to provide care for NCDs is not known. AIM: This study aimed to assess the capacity of ART sites to provide care for hypertension and diabetes in rural Malawi. SETTING: Twenty-five health centres and five hospitals in two rural districts in northern Malawi. METHODS: A cross-sectional survey was performed between March and May 2014 at all facilities. Qualitative interviews were held with three NCD coordinators. RESULTS: Treatment of hypertension and diabetes was predominantly hospital-based. Sixty percent of hospitals had at least one clinician and one nurse trained in NCD care, whereas 5% of health centres had a clinician and 8% had a nurse trained in NCD care. Hundred percent of hospitals and 92% of health centres had uninterrupted supply of hydrochlorothiazide in the previous 6 months, but only 40% of hospitals and no health centres had uninterrupted supply of metformin. Hundred percent of hospitals and 80% of health centres had at least one blood pressure machine, and 80% of hospitals and 32% of health centres had one glucometer. Screening for hypertension amongst ART patients was only conducted at one hospital and no health centres. At health centres, integrated NCD and ART care was more common, with 48% (12/25) providing ART and NCD treatment in the same consultation. CONCLUSIONS: The results reflect the status of the initial stages of the Malawi NCD programme at sites currently providing ART care.

You can treat my HIV ­ but can you treat my blood pressure? availability of integrated HIV and non-communicable disease care in northern Malawi

Background: Many patients on antiretroviral therapy (ART) in Malawi have or will develop non-communicable diseases(NCDs). The current capacity of ART sites to provide care for NCDs is not known. Aim: This study aimed to assess the capacity of ART sites to provide care for hypertension and diabetes in rural Malawi.Setting: Twenty-five health centres and five hospitals in two rural districts in northern Malawi. Methods: A cross-sectional survey was performed between March and May 2014 at all facilities. Qualitative interviews were held with three NCD coordinators. Results: Treatment of hypertension and diabetes was predominantly hospital-based. Sixty percent of hospitals had at least one clinician and one nurse trained in NCD care, whereas 5% of health centres had a clinician and 8% had a nurse trained in NCD care. Hundred percent of hospitals and 92% of health centres had uninterrupted supply of hydrochlorothiazide in the previous 6 months, but only 40% of hospitals and no health centres had uninterrupted supply of metformin. Hundred percent of hospitals and 80% of health centres had at least one blood pressure machine, and 80% of hospitals and 32% of health centres had one glucometer. Screening for hypertension amongst ART patients was only conducted at one hospital and no health centres. At health centres, integrated NCD and ART care was more common, with 48% (12/25) providing ART and NCD treatment in the same consultation. Conclusions: The results reflect the status of the initial stages of the Malawi NCD programme at sites currently providing ART 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.

High-risk human papillomavirus in HIV-infected women undergoing cervical cancer screening in Lilongwe, Malawi: a pilot study.

Rates of abnormal visual inspection with acetic acid and prevalence of high-risk human papillomavirus (HPV) subtypes have not been well characterized in HIV-infected women in Malawi. We performed a prospective cohort study of visual inspection with acetic acid (N = 440) in HIV-infected women aged 25--59 years, with a nested study of HPV subtypes in first 300 women enrolled. Of 440 women screened, 9.5% (N = 42) had abnormal visual inspection with acetic acid with 69.0% (N = 29) having advanced disease not amenable to cryotherapy. Of 294 women with HPV results, 39% (N = 114) of women were positive for high-risk HPV infection. Only lower CD4 count (287 cells/mm(3) versus 339 cells/mm(3), p = 0.03) and high-risk HPV (66.7% versus 35.6%, p < 0.01) were associated with abnormal visual inspection with acetic acid. The most common high-risk HPV subtypes in women with abnormal visual inspection with acetic acid were 35 (33.3%), 16 (26.7%), and 58 (23.3%). Low CD4 cell count was associated with abnormal visual inspection with acetic acid and raises the importance of early antiretroviral therapy and expanded availability of visual inspection with acetic acid. HPV vaccines targeting additional non-16/18 high-risk HPV subtypes may have greater protective advantages in countries such as Malawi.