Elimination of lymphatic filariasis as a public health problem in Malawi.

BACKGROUND: Lymphatic filariasis (LF) is a parasitic disease transmitted by mosquitoes, causing severe pain, disfiguring, and disabling clinical conditions such as lymphoedema and hydrocoele. LF is a global public health problem affecting 72 countries, primarily in Africa and Asia. Since 2000, the World Health Organization (WHO) has led the Global Programme to Eliminate Lymphatic Filariasis (GPELF) to support all endemic regions. This paper focuses on the achievements of the Malawi LF Elimination Programme between 2000 and 2020 to eliminate LF as a public health problem, making it the second sub-Saharan country to receive validation from the WHO. METHODOLOGY/PRINCIPAL FINDINGS: The Malawi LF Programme addressed the widespread prevalence of LF infection and disease across the country, using the recommended WHO GPELF strategies and operational research initiatives in collaboration with key national and international partners. First, to stop the spread of infection (i.e., interrupt transmission) and reduce the circulating filarial antigen prevalence from as high as 74.4% to below the critical threshold of 1-2% prevalence, mass drug administration (MDA) using a two-drug regime was implemented at high coverage rates (>65%) of the total population, with supplementary interventions from other programmes (e.g., malaria vector control). The decline in prevalence was monitored and confirmed over time using several impact assessment and post-treatment surveillance tools including the standard sentinel site, spot check, and transmission assessment surveys and alternative integrated, hotspot, and easy-access group surveys. Second, to alleviate suffering of the affected populations (i.e., control morbidity) the morbidity management and disability prevention (MMDP) package of care was implemented. Specifically, clinical case estimates were obtained via house-to-house patient searching activities; health personnel and patients were trained in self-care protocols for lymphoedema and/or referrals to hospitals for hydrocoele surgery; and the readiness and quality of treatment and services were assessed with new survey tools. CONCLUSIONS: Malawi's elimination of LF will ensure that future generations are not infected and suffer from the disfiguring and disabling disease. However, it will be critical that the Malawi LF Elimination programme remains vigilant, focussing on post-elimination surveillance and MMDP implementation and integration into routine health systems to support long-term sustainability and ongoing success. SUMMARY: Lymphatic filariasis, also known as elephantiasis, is a disabling, disfiguring, and painful disease caused by a parasite that infected mosquitoes transmit to millions of people worldwide. Since 2000, the Global Programme to Eliminate Lymphatic Filariasis (GPELF) has supported endemic countries such as Malawi in south-eastern Africa, to eliminate the disease as a public health problem. The Malawi National LF Elimination Programme has worked tirelessly over the past two decades to implement the GPELF recommended strategies to interrupt the transmission with a two-drug regime, and to alleviate suffering in patients with lymphoedema and/or hydrocoele through morbidity management and disability prevention. Additionally, the LF Programme has collaborated with national and international stakeholders to implement a range of supplementary operational research projects to address outstanding knowledge gaps and programmatic barriers. In 2020, the World Health Organisation validated that Malawi had successfully eliminated LF as a public health problem, making it the second country in sub-Saharan Africa to achieve this, which is remarkable given that Malawi previously had very high infection rates. The LF Programme now remains vigilant, putting its efforts towards post-elimination surveillance and the continued implementation of care for patients with chronic conditions. Malawi's elimination of LF will ensure that future generations are not affected by this devastating disease.

Acceptability and feasibility of tuberculosis and diabetes mellitus bidirectional screening and joint treatment services in Malawi: a cross-sectional study and a policy document review.

OBJECTIVES: A cross-sectional and a policy document review study was performed to investigate perceived acceptability and feasibility to implementing different integration measures for tuberculosis (TB) and diabetes mellitus (DM) healthcare among healthcare workers (HCWs) and health managers, and to describe policy influence through a policy documents review in Malawi. SETTING: The survey was performed at eight hospitals, ministry of health offices and 10 non-governmental organisations. We collected data in March and April 2021. PARTICIPANTS: Of 95 HCWs and health managers invited; 92 participated. 21/92 (23%) were female, and 17/92 (18%) participants were from clinics that piloted the integrated care for TB and DM. OUTCOME MEASURES: We described awareness levels on TB/DM comorbidity, perceptions and experiences in TB/DM care. Furthermore, development processes and contents of included documents were analysed. RESULTS: 16/17 (94%) of HCWs from clinics piloting integrated care and 65/75 (86%) HCWs from hospitals that do not use integrated care for TB and DM responded that integrated care was acceptable and feasible. In qualitative data, shortage of resources, inadequate information sharing were common themes. We included seven relevant documents for the analysis. On development process and content, six of seven documents were scored ≥70%. In these documents, DM is a recognised risk factor for TB, and integration of healthcare services for infectious diseases and non-communicable diseases is recommended, however, these documents lacked information specifically on integrated care for TB and DM. CONCLUSION: In this study, we identified inadequate information sharing, and lack of resources as major factors impeding implementation of integration of services, however, awareness on TB/DM comorbidity was high.

Economic impact of cholera in households in rural southern Malawi: a prospective study.

INTRODUCTION: Cholera remains a significant contributor to diarrhoeal illness, especially in sub-Saharan Africa. Few studies have estimated the cost of illness (COI) of cholera in Malawi, a cholera-endemic country. The present study estimated the COI of cholera in Nsanje, southern Malawi, as part of the Cholera Surveillance in Malawi (CSIMA) programme following a mass cholera vaccination campaign in 2015. METHODS: Patients ≥12 months of age who were recruited as part of CSIMA were invited to participate in the COI survey. The COI tool captured household components of economic burden, including direct medical and non-medical costs, and indirect lost productivity costs. RESULTS: Between April 2016 and March 2020, 40 cholera cases were enrolled in the study, all of whom participated in the COI survey. Only two patients had any direct medical costs and five patients reported lost wages due to illness. The COI per patient was US$14.34 (in 2020), more than half of which was from direct non-medical costs from food, water, and transportation to the health centre. CONCLUSION: For the majority of Malawians who struggle to subsist on less than US$2 a day, the COI of cholera represents a significant cost burden to families. While cholera treatment is provided for free in government-run health centres, additional investments in cholera control and prevention at the community level and financial support beyond direct medical costs may be necessary to alleviate the economic burden of cholera on households in southern Malawi.

The causal effect of a family planning intervention on women's contraceptive use and birth spacing.

Studies have suggested that improving access to family planning (FP) may improve contraceptive use and reduce fertility. However, high-quality evidence, particularly from randomized implementation trials, of the effect of FP programs and interventions on longer-term fertility and birth spacing is lacking. We conduct a nonblinded, randomized, controlled trial to assess the causal impact of improved access to FP on contraceptive use and pregnancy spacing in Lilongwe, Malawi. A total of 2,143 married women aged 18 to 35 who were either pregnant or had recently given birth were recruited through home visits between September 2016 and January 2017 and were randomly assigned to an intervention arm or a control arm. The intervention arm received four services over a 2-y period: 1) up to six FP counseling sessions; 2) free transportation to an FP clinic; 3) free FP services at the clinic or financial reimbursement for FP services obtained elsewhere; and 4) treatment for contraceptive-related side effects. Contraceptive use after 2 y of intervention exposure increased by 5.9 percentage points, mainly through an increased use of contraceptive implants. The intervention group's hazard of pregnancy was 43.5% lower 24 mo after the index birth. Our results highlight the positive impact of increased access to FP on a woman's contraceptive use. In addition, we show that exposure to the FP intervention led to a prolongation of birth intervals among intervention women relative to control women and increased her control over birth spacing and postpartum fertility, which, in turn, may contribute to her longer-term health and well-being.

Bidirectional screening and treatment outcomes of diabetes mellitus (DM) and Tuberculosis (TB) patients in hospitals with measures to integrate care of DM and TB and those without integration measures in Malawi.

INTRODUCTION: There are efforts in low and middle-income countries (LMICs) to integrate Tuberculosis (TB) and Diabetes mellitus (DM) healthcare services, as encouraged by WHO and other international health organizations. However, evidence on actual effect of different integration measures on bidirectional screening coverages and or treatment outcomes for both diseases in LMICs is scarce. OBJECTIVES AND METHODS: Retrospective chart review analysis was conducted to determine effects of integrated care on bidirectional screening and treatment outcomes for both TB patients and people with DM (PWD) recruited in eight Malawian hospitals. Data of ≥ 15 years old patients registered between 2016 to August 2019 were collected and analysed. RESULTS: 557 PWDs (mean age 54) and 987 TB patients (mean age 41) were recruited. 64/557 (11.5%) PWDs and 105/987 (10.6%) of TB patients were from an integrating hospital. 36/64 (56.3%) PWDs were screened for TB in integrated healthcare as compared to 5/493 (1.0%) in non-integrated care; Risk Difference (RD) 55.2%, (95%CI 43.0, 67.4), P < 0.001, while 10/105 (9.5%) TB patients were screened for DM in integrated healthcare as compared to 43/882 (4.9%) in non-integrated care; RD 4.6%, (95%CI - 1.1, 10.4), P = 0.065. Of the PWDs screened, 5/41 (12.2%) were diagnosed with TB, while 5/53 (9.4%) TB patients were diagnosed with DM. On TB treatment outcomes, 71/508 (14.8%) were lost to follow up in non-integrated care and none in integrated care were lost to follow-up; RD - 14.0%, (95%CI: - 17.0,-11.0), p < 0.001. Among PWDs, 40/493 (8.1%) in non-integrated care and 2/64 (3.1%) were lost to follow up in integrated care; RD - 5.0%, (95%CI:-10.0, - 0.0); P = 0.046. After ≥ 2 years of follow up, 62.5% PWDs in integrated and 41.8% PWDs in non-integrated care were retained in care, RD 20.7, (95%CI: 8.1, 33.4), P = 0.001. CONCLUSION: We found higher bidirectional screening coverage and less loss to follow-up in one centre that made more efforts to implement integrated measures for TB and DM care than in 7 others that did not make these efforts. Decisions on local programs to integrate TB/DM care should be taken considering currently rather weak evidence and barriers faced in the local context as well as existing guidelines.

Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: protocol for a cluster randomized feasibility trial.

BACKGROUND: Cervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi's public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated. METHODS: We designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact. DISCUSSION: Our trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04286243 . Registered on February 26, 2020.

Cost-effectiveness of a reactive oral cholera immunization campaign using Shanchol™ in Malawi.

BACKGROUND: Oral cholera vaccines (OCV) have been recommended as additional measures for the prevention of cholera. However, little is known about the cost-effectiveness of OCV use in sub-Saharan Africa, particularly in reactive outbreak contexts. This study aimed to investigate the cost-effectiveness of the use of OCV Shanchol in response to a cholera outbreak in the Lake Chilwa area, Malawi. METHODS: The Excel-based Vaccine Introduction Cost-Effectiveness model was used to assess the cost-effectiveness ratios with and without indirect protection. Model input parameters were obtained from cost evaluations and epidemiological studies conducted in Malawi and published literature. One-way sensitivity and threshold analyses of cost-effectiveness ratios were performed. RESULTS: Compared with the reference scenario i.e. treatment of cholera cases, the immunization campaign would have prevented 636 and 1 020 cases of cholera without and with indirect protection, respectively. The cost-effectiveness ratios were US$19 212 per death, US$500 per case, and US$738 per DALY averted without indirect protection. They were US$10 165 per death, US$264 per case, and US$391 per DALY averted with indirect protection. The net cost per DALY averted was sensitive to four input parameters, including case fatality rate, duration of immunity (vaccine's protective duration), discount rate and cholera incidence. CONCLUSION: Relative to the Malawi gross domestic product per capita, the reactive OCV campaign represented a cost-effective intervention, particularly when considering indirect vaccine effects. Results will need to be assessed in other settings, e.g., during campaigns implemented directly by the Ministry of Health rather than by international partners.

Adolescent and covert family planning users' experiences self-injecting contraception in Uganda and Malawi: implications for waste disposal of subcutaneous depot medroxyprogesterone acetate.

BACKGROUND: Self-administered subcutaneous depot medroxyprogesterone acetate (DMPA-SC) is poised to increase access to contraception; however, governments are concerned about the waste management of used units. Self-injectors in Malawi and Uganda are currently instructed to store used units in containers and return them to health workers for disposal. However, this may not be feasible in low-resource settings, especially for younger or covert self-injectors. We describe adolescent (15-19 years) and adult (20-49 years) self-injectors' disposal experiences in Uganda and Malawi. When possible, we compare covert and overt users' experiences. METHODS: We conducted cross-sectional qualitative studies in 2019 with 50 self-injectors in Uganda and 60 in Malawi. We purposively selected approximately half adolescents and included those trained by clinic-based providers and community health workers. We conducted semi-structured interviews and thematic data analysis and compared the findings across settings. RESULTS: Just under half of both samples were adolescents, substantially more of whom were covert users in Uganda (68%) than Malawi (~ 10%). Most participants reported being told to store used units in a container and return them to health workers. About two-thirds of Uganda participants had disposed of at least one unit by the interview, most commonly returning them to health workers. Over one-third of Malawi participants had disposed of at least one unit by the interview, slightly more disposed into latrines compared to returning to health workers. Participants in both settings reported compliance with health workers' disposal instructions as a primary reason for their disposal method. One-fifth of Uganda participants, mostly adolescent covert users, and one-quarter in Malawi said they were told they could dispose into latrines, and often did so. The majority in both settings said they would prefer to dispose units in latrines because they worried about needlestick injuries to others and because it was convenient. Some Uganda adolescent covert users felt returning units to health workers was challenging due to privacy concerns. CONCLUSIONS: While most self-injectors disposed of used units as instructed, findings from both studies suggest that returning units to health workers is not preferred and may not be feasible for some adolescent covert users. More convenient disposal solutions should be identified.

Young Women's Experiences With Subcutaneous Depot Medroxyprogesterone Acetate: A Secondary Analysis of a One-Year Randomized Trial in Malawi.

PURPOSE: The purpose of this study was to compare the effectiveness, safety, and experiences with side effects of self-injected and provider-administered injectable contraception between young (18-24 years) versus older (≥25 years) women. METHODS: We conducted secondary analysis of data from a 12-month randomized controlled trial in Malawi, where a total of 731 women were randomized to receive subcutaneous depot medroxyprogesterone acetate (DMPA-SC) administered by a provider or be trained to self-inject subcutaneous depot medroxyprogesterone acetate. Data collectors contacted women after the reinjection window at 3, 6, and 9 months to collect data on discontinuation and women's experiences, including adverse events. Twelve months after enrollment or at early discontinuation, women had their final interview, including pregnancy testing. We compared continuation, pregnancy, safety, and side effects among young women versus older women. RESULTS: Among self-injectors, there were no significant differences found in continuation by age (p = .345) with continuation rates at 12 months of 79% for young women and 69% for older women. Continuation rates were lower for both age groups with provider-administered injections. In the provider-administered group, continuation rates among young women (39%) were lower than among older women (49%) (p = .047). The distribution of reasons for discontinuation did not differ significantly by age for those receiving provider injections (p = .698). However, younger self-injectors were less likely to miss the reinjection window than older self-injectors (p = .011). Age did not significantly influence pregnancy or safety. CONCLUSIONS: With evidence of potential higher impact on continuation and no safety concerns, we recommend self-injection be added to the contraception options available to young women in low-resource settings.

Risk Factors Associated With Increased Mortality From Intussusception in African Infants.

OBJECTIVES: Morbidity and mortality from intussusception, the leading cause of bowel obstruction in infants, is higher in Africa than in other regions of the world, but the reasons have not been well examined. We sought to identify risk and protective factors associated with death or intestinal resection following intussusception. METHODS: Infants with intussusception from 7 sub-Saharan African countries (Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia, and Zimbabwe) were enrolled through active, hospital-based surveillance from February 2012 to December 2016. We examined demographic, clinical, and socioeconomic factors associated with death or intestinal resection following intussusception, using multivariable logistic regression. RESULTS: A total of 1017 infants <1 year of age with intussusception were enrolled. Overall, 13% of children (133/1017) died during the hospitalization, and 48% (467/966) required intestinal resection. In multivariable analyses, female sex [odds ratio (OR) 1.8, 95% confidence interval (CI) 1.2-3.3], longer duration of symptoms before presentation (OR 1.1; 95% CI 1.0-1.2), and undergoing intestinal resection (OR 3.4; 95% CI 1.9-6.1) were associated with death after intussusception. Diagnosis by ultrasound or enema (OR 0.4; 95% CI 0.3-0.7), and employment of a household member (OR 0.7; 95% CI 0.4-1.0) were protective against intestinal resection. CONCLUSIONS: Delays in hospital presentation and female sex were significantly associated with death, whereas higher socioeconomic status and availability of radiologic diagnosis reduced likelihood of undergoing resection. Efforts should be intensified to improve the awareness, diagnosis, and management of intussusception in sub-Saharan African countries to reduce morbidity and mortality from intussusception in these resource-limited settings.

Health literacy among Malawian HIV-positive youth: a qualitative needs assessment and conceptualization.

Despite growing evidence of the significance of health literacy in managing and coping with acquired immune deficiency syndrome (HIV), it is not yet an integrated part of HIV/AIDS-related health promotion research and practice in Africa. This article contributes to addressing the gap in research on health literacy and HIV in Sub-Saharan Africa. We aimed to assess health literacy-related needs of young people living with HIV (YPLHIV) and adapt existing health literacy frameworks to the context of HIV/AIDS in Malawi. We used focus group discussions to collect data from a sample of the membership of the national association of YPLHIV. Twenty-four HIV-positive youth (18-29 years) participated in focus group discussions. Participants came from three regions of Malawi. Additionally, we conducted three in-depth interviews with key informants. We used a thematic framework approach to analyse data in MAXQDA. We contextualized definitions of four dimensions of health literacy: functional, interactive, critical and distributed health literacy, which we used as an a priori analytical framework. To further contextualize the framework, we revised it iteratively throughout the analysis process. We identified the need for comprehensive information about HIV and sexual reproductive health, skills to interact with healthcare providers and navigate the health system, and skills to appraise information from different sources, among others. The identified needs were translated into nine action recommendations for the national association of YPLHIV, and with relevance within the wider HIV sector in Malawi and beyond. We found that the dimensions in our analytical framework operate on the individual, system and public policy levels.

Maternal immunization in Malawi: A mixed methods study of community perceptions, programmatic considerations, and recommendations for future planning.

BACKGROUND: Safe, effective vaccines are given to pregnant women to protect their infants and/or themselves against certain infectious agents; however, apart from tetanus vaccination, maternal immunization in low- and middle-income countries (LMICs) remains low. Tetanus toxoid vaccine is integrated into antenatal care services in Malawi with high coverage and provides an opportunity to identify factors that facilitate successful immunization delivery to pregnant women in LMICs. METHODS: PATH and the University of Malawi's Centre for Social Research conducted a mixed-methods study in 2015 to document community perceptions of maternal immunization, using tetanus vaccine as an example, and to identify factors perceived to be important to successfully introducing other maternal vaccines, such as influenza vaccine, in Malawi. We conducted 18 focus group discussions with pregnant and recently pregnant women and their family members and 76 semi-structured interviews with pregnant and recently pregnant women, community leaders, health workers, public health program managers, non-governmental partners, and policy makers. RESULTS: We identified factors perceived to support the introduction of new maternal vaccines, including strong maternal vaccine acceptance in the community, an existing strategy for maternal tetanus vaccine delivery, and positive health workers' views about the introduction of additional maternal vaccines. Potential challenges to adoption and acceptance included identifying and tracking the target population and monitoring adverse events, and the need to ensure operational capacity of the health system to support the introduction and wide-scale use of an additional vaccine. For influenza vaccine specifically, additional challenges included limited awareness of influenza disease and its low prioritization among health needs. CONCLUSIONS: Lessons from the successful delivery of maternal tetanus immunization in Malawi may be informative for similar countries considering new vaccines for pregnant women or striving to optimize the delivery of those currently provided.

Inactivation of pathogens in ecological sanitation latrines in Malawi: An observational follow up study.

Introduction: In Malawi, EcoSan sludge from ecological sanitation (EcoSan) latrines has been found to contain helminths, Salmonella and E. coli above WHO recommended levels making sludge unsuitable for direct handling and use on food crops. This research investigated survival of pathogens in EcoSan sludge with time after sealing the pit. Method: An observational longitudinal follow-up study was conducted where EcoSan latrines were followed from August 2015 to July 2016 in Blantyre and Chikwawa in Southern Malawi. The study enrolled 51 latrines in total with 35 latrines [13 fossa alterna (FAs) and 22 urine diverting dry latrines (UDDLs)] remaining at the end of study. Samples were collected five times from each latrine and examined for helminths, Salmonella and E. coli in the laboratory. Poisson regression was employed to assess factors that significantly contribute to pathogen die off at p<0.05. Results: Average concentrations of all pathogens investigated reduced over 12-month follow-up period except for Salmonella which increased. A. lumbricoides, increased to 2.3 viable eggs during the second sampling and decreased to 0.4 viable eggs per gram after 12 months of follow-up. Time was the only consistent predictor for concentration of helminths. Type of latrine and location were not significant predictors of helminths concentration (p>0.05). However, Salmonella and E. coli colonies were significantly higher in UDDLs (Blantyre) than FAs (Chikwawa) (p<0.05). Conclusion: Pathogen concentration was highest after recommended six months of storage posing a public health risk to those handling and using it for agriculture purposes. It is therefore recommended that the current guidelines be reviewed to suit Malawi context. A storage period of one year or more is recommended.

Factors Affecting Continued Use of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SC): A Secondary Analysis of a 1-Year Randomized Trial in Malawi.

OBJECTIVE: To assess the supply- and demand-side factors influencing continued use of the injectable contraceptive subcutaneous depot medroxyprogesterone acetate (DMPA-SC). METHODS: We conducted a 12-month randomized controlled trial in Malawi to measure DMPA-SC continuation rates. A total of 731 women presenting to clinic-based providers (CBPs) at 6 Ministry of Health clinics or to community health workers (CHWs) in rural communities were randomized to receive DMPA-SC administered by a provider or be trained to self-inject DMPA-SC. Data collectors contacted women after the reinjection window at 3, 6, and 9 months to collect data on discontinuation and women's experiences. Twelve months after enrollment or at early discontinuation, women had their final interview, including pregnancy testing. We compared continuation, pregnancy, and safety by whether DMPA-SC or self-injection training was provided by CHWs versus CBPs. We also conducted an exploratory analysis assessing the association between women's sociodemographic factors and the risk for discontinuation using stratified Cox proportional hazards models. FINDINGS: The type of provider did not seem to influence continuation, pregnancy, or safety. As reported previously, women in the self-injection group were significantly less likely to discontinue the method compared with women in the provider-administered group (hazard ratio, 0.43; P<.001). The risk for discontinuation was also different among health facility catchment sites (P<.001). No other assessed sociodemographic factors were found to significantly influence the risk for discontinuation. CONCLUSIONS: Public-sector CHWs can safely and effectively provide DMPA-SC and train women to self-inject DMPA-SC in low-resource settings. DMPA-SC continuation did not seem to be influenced by the type of provider, whether CBP or CHW, or women's sociodemographic characteristics.

Alcohol policies in Malawi: inclusion of WHO "best buy" interventions and use of multi-sectoral action.

BACKGROUND: Harmful use of alcohol is one of the most common risk factors for Non-Communicable Diseases and other health conditions such as injuries. World Health Organization has identified highly cost-effective interventions for reduction of alcohol consumption at population level, known as "best buy" interventions, which include tax increases, bans on alcohol advertising and restricted access to retailed alcohol. This paper describes the extent of inclusion of alcohol related "best buy" interventions in national policies and also describes the application of multi-sectoral action in the development of alcohol policies in Malawi. METHODS: The study was part of a multi-country research project on Analysis of Non-Communicable Disease Preventive Policies in Africa, which applied a qualitative case study design. Data were collected from thirty-two key informants through interviews. A review of twelve national policy documents that relate to control of harmful use of alcohol was also conducted. Transcripts were coded according to a predefined protocol followed by thematic content analysis. RESULTS: Only three of the twelve national policy documents related to alcohol included at least one "best buy" intervention. Multi-Sectoral Action was only evident in the development process of the latest alcohol policy document, the National Alcohol Policy. Facilitators for multi-sectoral action for alcohol policy formulation included: structured leadership and collaboration, shared concern over the burden of harmful use of alcohol, advocacy efforts by local non-governmental organisations and availability of some dedicated funding. Perceived barriers included financial constraints, high personnel turnover in different government departments, role confusion between sectors and some interference from the alcohol industry. CONCLUSIONS: Malawi's national legislations and policies have inadequate inclusion of the "best buy" interventions for control of harmful use of alcohol. Effective development and implementation of alcohol policies require structured organisation and collaboration of multi-sectoral actors. Sustainable financing mechanisms for the policy development and implementation processes should be considered; and the influence of the alcohol industry should be mitigated.

Oral cholera vaccine in cholera prevention and control, Malawi.

PROBLEM: With limited global supplies of oral cholera vaccine, countries need to identify priority areas for vaccination while longer-term solutions, such as water and sanitation infrastructure, are being developed. APPROACH: In 2017, Malawi integrated oral cholera vaccine into its national cholera control plan. The process started with a desk review and analysis of previous surveillance and risk factor data. At a consultative meeting, researchers, national health and water officials and representatives from nongovernmental and international organizations reviewed the data and local epidemiological knowledge to determine priority districts for oral cholera vaccination. The final stage was preparation of an application to the global oral cholera vaccine stockpile for non-emergency use. LOCAL SETTING: Malawi collects annual data on cholera and most districts have reported cases at least once since the 1970s. RELEVANT CHANGES: The government's application for 3.2 million doses of vaccine to be provided over 20 months in 12 districts was accepted in April 2017. By April 2018, over 1 million doses had been administered in five districts. Continuing surveillance in districts showed that cholera outbreaks were notably absent in vaccinated high-risk areas, despite a national outbreak in 2017-2018. LESSONS LEARNT: Augmenting advanced mapping techniques with local information helped us extend priority areas beyond those identified as high-risk based on cholera incidence reported at the district level. Involvement of the water, sanitation and hygiene sectors is key to ensuring that short-term gains from cholera vaccine are backed by longer-term progress in reducing cholera transmission.

Women's satisfaction, use, storage and disposal of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) during a randomized trial.

OBJECTIVE: To describe women's experiences with subcutaneous depot medroxyprogesterone acetate (DMPA-SC) to inform scale-up of self-administered DMPA-SC. STUDY DESIGN: We conducted a 12-month randomized controlled trial in Malawi to measure DMPA-SC continuation rates. A total of 731 women presenting at six Ministry of Health clinics or to community health workers (CHWs) in rural communities were randomized to receive DMPA-SC administered by a provider or be trained to self-inject DMPA-SC. Data collectors contacted women after the reinjection window at 3, 6 and 9 months to collect data on satisfaction and use; self-injectors were also queried about storage and disposal of DMPA-SC. We compared frequencies of injection experiences and satisfaction by study group and over time. RESULTS: Ninety-two percent of women who self-injected felt it was easy to do the first time. Women in the self-administered group primarily gave themselves the injection versus having someone else inject them; stored DMPA-SC mostly in bags, often in ways to keep the product away from others; and properly disposed of DMPA-SC in pit latrines. Women in both groups used printed calendars to remember when to get/be given their next injection. Both groups reported high satisfaction with DMPA-SC. CONCLUSIONS: Women in low-resource settings can be successfully trained by public sector CHWs and clinic-based providers to self-inject and to appropriately store and dispose of DMPA-SC. DMPA-SC and self-injection are acceptable and feasible in a low-resource setting. IMPLICATIONS: Self-administered and provider-administrated DMPA-SC should be scaled up, and the lessons learned during our trial should be applied to future scale-up efforts.

Client and provider experiences with self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in Malawi.

OBJECTIVE: As low- and middle-income countries (LMICs) consider adding self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) to their contraceptive method mix, learning about family planning clients' and providers' experiences with self-injectable DMPA-SC during trials will inform introduction and scale-up efforts. STUDY DESIGN: We conducted semistructured interviews with 30 randomly selected adult women enrolled in the self-administration group of a 12-month randomized controlled trial studying DMPA-SC continuation rates in rural Malawi. We asked about their experiences learning to self-inject, self-injecting, remembering when to reinject, and storing and disposing of DMPA-SC. We also interviewed 12 providers - clinic-based providers (CBPs) and community-based health surveillance assistants (HSAs) - who trained clients to self-inject DMPA-SC during the trial. We asked about their experiences training and supporting women to self-inject DMPA-SC during the trial and their recommendations for scale-up of self-administered DMPA-SC. RESULTS: Clients and providers reported positive experiences with DMPA-SC self-injection. Clients felt that DMPA-SC self-injection saved them time and money, and providers felt that it reduced their workload and saved them time. We found that both CBPs and HSAs successfully trained clients to self-inject DMPA-SC and that clients safely and appropriately stored and disposed of DMPA-SC. CONCLUSIONS: Our findings contribute to the growing body of evidence of the feasibility of DMPA-SC self-injection in LMIC settings. We recommend that providers plan to train clients for at least 30min, emphasize the activating and injecting steps during training, use up to four practice injections per client trained and give self-injectors calendars to help them remember when to reinject. IMPLICATIONS: DMPA-SC self-administration should be made available in LMIC settings, but because it is a new practice, implementation guidance is needed. We offer practical recommendations for introducing and scaling up DMPA-SC self-administration based on clients' and providers' experiences during a trial investigating this practice in Malawi.

Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa.

BACKGROUND: Postlicensure evaluations have identified an association between rotavirus vaccination and intussusception in several high- and middle-income countries. We assessed the association between monovalent human rotavirus vaccine and intussusception in lower-income sub-Saharan African countries. METHODS: Using active surveillance, we enrolled patients from seven countries (Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia, and Zimbabwe) who had intussusception that met international (Brighton Collaboration level 1) criteria. Rotavirus vaccination status was confirmed by review of the vaccine card or clinic records. The risk of intussusception within 1 to 7 days and 8 to 21 days after vaccination among infants 28 to 245 days of age was assessed by means of the self-controlled case-series method. RESULTS: Data on 717 infants who had intussusception and confirmed vaccination status were analyzed. One case occurred in the 1 to 7 days after dose 1, and 6 cases occurred in the 8 to 21 days after dose 1. Five cases and 16 cases occurred in the 1 to 7 days and 8 to 21 days, respectively, after dose 2. The risk of intussusception in the 1 to 7 days after dose 1 was not higher than the background risk of intussusception (relative incidence [i.e., the incidence during the risk window vs. all other times], 0.25; 95% confidence interval [CI], <0.001 to 1.16); findings were similar for the 1 to 7 days after dose 2 (relative incidence, 0.76; 95% CI, 0.16 to 1.87). In addition, the risk of intussusception in the 8 to 21 days or 1 to 21 days after either dose was not found to be higher than the background risk. CONCLUSIONS: The risk of intussusception after administration of monovalent human rotavirus vaccine was not higher than the background risk of intussusception in seven lower-income sub-Saharan African countries. (Funded by the GAVI Alliance through the CDC Foundation.).

Effect of self-administration versus provider-administered injection of subcutaneous depot medroxyprogesterone acetate on continuation rates in Malawi: a randomised controlled trial.

BACKGROUND: Injectable contraceptives are popular in sub-Saharan Africa but have high discontinuation rates due partly to the need for provider-administered re-injection. We compared continuation rates of women who self-injected subcutaneous depot medroxyprogesterone acetate (DMPA-SC) and women who received DMPA-SC from a health-care provider, including community health workers (CHWs). METHODS: We did an open-label randomised controlled trial based at six Ministry of Health clinics in rural Mangochi District, Malawi. Health-care providers recruited adult women who presented at the six clinics or to CHWs in rural communities in the clinic catchment areas. Participants received DMPA-SC and were randomised (1:1) to receive provider-administered injections or training in how to self-inject DMPA-SC. Randomisation was done via a computer-generated block randomisation schedule with block sizes of four, six, and eight and stratified by study site, generated by an independent statistician. Self-injectors administered the first injection under observation and were sent home with three doses, written instructions, and a calendar. The provider-administered group received a DMPA-SC injection and a calendar, and were asked to return for subsequent injections. Data collectors contacted participants after the 14-week re-injection window at 3, 6, and 9 months to collect continuation data. At 12 months after enrolment or early discontinuation, women had their final interview, which included pregnancy testing. The primary outcome was discontinuation of DMPA-SC, as assessed in the intention-to-treat population. We used Kaplan-Meier methods to estimate the probabilities of continuation and a log-rank test to compare groups. Safety was assessed in the as-treated population, which consisted only of participants who successfully received at least one DMPA-SC injection after randomisation. This trial is registered with ClinicalTrials.gov, number NCT02293694. FINDINGS: This study lasted from Sept 17, 2015, to Feb 21, 2017. 731 women underwent randomisation, with 364 assigned to the self-administered group and 367 to the provider-administered group. One woman in the self-injection group withdrew at month 0. Treatment was discontinued by 99 women in the self-administered group and 199 women in the provider-administered group. The 12 month continuation rate was 73% in the self-injection group and 45% in the provider-administered group, giving an incidence rate ratio of 0·40 (95% CI 0·31-0·51; p<0·0001). Adverse events deemed to potentially be treatment-related were reported by ten women (20 events) in the self-administered group and 17 women (28 events) in the provider-administered group. Five serious adverse events were reported during the trial by four women; two events related to DMPA-SC (menorrhagia and anaemia requiring hospital admission) were reported by the same woman in the provider-administered group and resolved without sequelae. The other serious adverse events, including one death, were deemed to be unrelated to DMPA-SC. INTERPRETATION: Women who self-injected DMPA-SC had significantly higher rates of continuation than those receiving provider-injected DMPA-SC. Community-based provision of injectable contraception for self-injection in low-resource settings seems to be safe and feasible. Self-administration of DMPA-SC should be made widely available. FUNDING: United States Agency for International Development and Children's Investment Fund Foundation.