Implementation of a human papillomavirus vaccination demonstration project in Malawi: successes and challenges.

BACKGROUND: Cervical cancer is a major public health problem in Malawi. The age-standardized incidence and mortality rates are estimated to be 75.9 and 49.8 per 100,000 population, respectively. The availability of the human papillomavirus (HPV) vaccine presents an opportunity to reduce the morbidity and mortality associated with cervical cancer. In 2013, the country introduced a school-class-based HPV vaccination pilot project in two districts. The aim of this study was to evaluate HPV vaccine coverage, lessons learnt and challenges identified during the first three years of implementation. METHODS: This was an evaluation of the HPV vaccination project targeting adolescent girls aged 9-13 years conducted in Malawi from 2013 to 2016. We analysed programme data, supportive supervision reports and minutes of National HPV Task Force meetings to determine HPV vaccine coverage, reasons for partial or no vaccination and challenges. Administrative coverage was validated using a community-based coverage survey. RESULTS: A total of 26,766 in-school adolescent girls were fully vaccinated in the two pilot districts during the first three years of the programme. Of these; 2051 (7.7%) were under the age of 9 years, 884 (3.3%) were over the age of 13 years, and 23,831 (89.0%) were aged 9-13 years (the recommended age group). Of the 765 out-of-school adolescent girls aged 9-13 who were identified during the period, only 403 (52.7%) were fully vaccinated. In Zomba district, the coverage rates of fully vaccinated were 84.7%, 87.6% and 83.3% in year 1, year 2 and year 3 of the project, respectively. The overall coverage for the first three years was 82.7%, and the dropout rate was 7.7%. In Rumphi district, the rates of fully vaccinated coverage were 90.2% and 96.2% in year 1 and year 2, respectively, while the overall coverage was 91.3%, and the dropout rate was 4.9%. Administrative (facility-based) coverage for the first year was validated using a community-based cluster coverage survey. The majority of the coverage results were statistically similar, except for in Rumphi district, where community-based 3-dose coverage was higher than the corresponding administrative-coverage (94.2% vs 90.2%, p < 0.05), and overall (in both districts), facility-based 1-dose coverage was higher than the corresponding community-based (94.6% vs 92.6%, p < 0.05). Transferring out of the district, dropping out of school and refusal were some of the reasons for partial or no uptake of the vaccine. CONCLUSION: In Malawi, the implementation of a school-class-based HPV vaccination strategy was feasible and produced high (>80%) coverage. However, this strategy may be associated with the vaccination of under- and over-aged adolescent girls who are outside of the vaccine manufacturer's stipulated age group (9-13 years). The health facility-based coverage for out-of-school adolescent girls produced low coverage, with only half of the target population being fully vaccinated. These findings highlight the need to assess the immunogenicity associated with the administration of a two-dose schedule to adolescent girls younger or older than 9-13 years and effectiveness of health facility-based strategy before rolling out the programme.

Safety of a killed oral cholera vaccine (Shanchol) in pregnant women in Malawi: an observational cohort study.

BACKGROUND: Pregnancy increases the risk of harmful effects from cholera for both mothers and their fetuses. A killed oral cholera vaccine, Shanchol (Shantha Biotechnics, Hydrabad, India), can protect against the disease for up to 5 years. However, cholera vaccination campaigns have often excluded pregnant women because of insufficient safety data for use during pregnancy. We did an observational cohort study to assess the safety of Shanchol during pregnancy. METHODS: This observational cohort study was done in two adjacent districts (Nsanje and Chikwawa) in Malawi. Individuals older than 1 year in Nsanje were offered oral cholera vaccine during a mass vaccination campaign between March 30 and April 30, 2015, but no vaccines were administered in Chikwawa. We enrolled women who were exposed to oral cholera vaccine during pregnancy in Nsanje district, and women who were pregnant in Chikwawa district (and thus not exposed to oral cholera vaccine) during the same period. The primary endpoint of our analysis was pregnancy loss (spontaneous miscarriage or stillbirth), and the secondary endpoints were neonatal deaths and malformations. We evaluated these endpoints using log-binomial regression, adjusting for the imbalanced baseline characteristics between the groups. This study is registered with ClinicalTrials.gov, number NCT02499172. FINDINGS: We recruited 900 women exposed to oral cholera vaccine and 899 women not exposed to the vaccine between June 16 and Oct 10, 2015, and analysed 835 in each group. 361 women exposed to the vaccine and 327 not exposed to the vaccine were recruited after their pregnancies had ended. The incidence of pregnancy loss was 27·54 (95% CI 18·41-41·23) per 1000 pregnancies among those exposed to the vaccine and 21·56 (13·65-34·04) per 1000 among those not exposed. The adjusted relative risk for pregnancy loss among those exposed to oral cholera vaccine was 1·24 (95% CI 0·64-2·43; p=0·52) compared with those not exposed to the vaccine. The neonatal mortality rate was 11·78 (95% CI 5·92-23·46) per 1000 livebirths for infants whose mothers were exposed to oral cholera vaccine versus 8·91 (4·02-19·77) per 1000 livebirths for infants whose mothers were not exposed to the vaccine (crude relative risk 1·32, 95% CI 0·46-3·84; p=0·60). Only three newborn babies had malformations, two in the vaccine exposure group and one in the no-exposure group, yielding a relative risk of 2·00 (95% CI 0·18-22·04; p=0·57), although this estimate is unreliable because of the small number of outcomes. INTERPRETATION: Our study provides evidence that fetal exposure to oral cholera vaccine confers no significantly increased risk of pregnancy loss, neonatal mortality, or malformation. These data, along with findings from two retrospective studies, support use of oral cholera vaccine in pregnant women in cholera-affected regions. FUNDING: Bill & Melinda Gates Foundation.

Cervical cancer screening uptake and challenges in Malawi from 2011 to 2015: retrospective cohort study.

BACKGROUND: Malawi has the highest cervical cancer incidence and mortality in the world with age-standardized rate (ASR) of 75.9 and 49.8 per 100,000 population respectively. In response, Ministry of Health established a cervical cancer screening programme using visual inspection with acetic acid (VIA) and treatment of precancerous lesions with cryotherapy. This paper highlights the roll out, integration with family planning services and HIV ART Programme, uptake and challenges of VIA and Cryotherapy programme. METHODS: We analyzed program data, supportive supervision, quarterly and annual reports from the National Cervical Cancer Control Program. We evaluated the uptake and challenges of screening services by age, HIV serostatus and trends over a five year period (2011-2015). RESULTS: Between 2011 and 2015, number of cervical cancer screening sites, number of women screened and coverage per annum increased from 75 to 130, 15,331 to 49,301 and 9.3 % to 26.5 % respectively. In this five year period, a total of 145,015 women were screened. Of these, 7,349 (5.1 %) and 6,289 (4.3 %) were VIA positive and suspect cancer respectively. Overall 13,638 (9.4 %) were detected to be VIA positive or had suspect cancer. Of the 48,588 women with known age screened in 2015; 13,642 (28.1 %), 27,275 (56.1 %) and 7,671 (15.8 %) were aged 29 or less, 30-45, 46 years or more. Among 39,101 women with data on HIV serostatus; 21,546 (55.1 %) were HIV negative, 6,209 (15.9 %) were HIV positive and 11, 346 (29.0 %) status was unknown. VIA positivity rate and prevalence of suspect cancer were significantly higher in HIV positive than HIV negative women (8.8 % vs 5.0 %, 6.4 % vs 3.0 %); in women aged 30-45 years than women aged 29 years or less (5.6 % vs 2.3 %, 2.6 % vs 1.2 %) respectively, all p <0.05). The main challenge of the programme was failure to treat VIA positive women eligible for cryotherapy. Over the five year period, the programme only treated 1,001 (43.3 %) out of 2,311 eligible women and only 266 (31.8 %) of the 836 women with large lesion or suspect cancer who were referred, received the health care at the referral centre. The reasons for failure to provide cryotherapy treatment were stock out of gas, faulty/broken cryotherapy machine (usually connectors or probes) or no cryotherapy machine at all in the whole district. For women with large lesion or suspect cancer; lack of loop electrosurgical excision procedure (LEEP) machine or inadequate gynaecologists at the referral centre, were the major reasons. Cancer radiotherapy services were not available in Malawi. CONCLUSIONS: This study provided data on VIA positivity rate, prevalence of suspect cancer, failure rate of cryotherapy and challenges in the provision of cryotherapy and LEEP treatment in Malawi. These data could be used as baseline for monitoring and evaluation of Human Papillomavirus (HPV) vaccination programme which the country introduced in 2013, the linkage of cervical cancer screening and women on HIV ART and the long term effect of ART, voluntary male medical circumcision on the prevalence and incidence of cervical cancer.

Feasibility and acceptability of oral cholera vaccine mass vaccination campaign in response to an outbreak and floods in Malawi.

INTRODUCTION: Despite some improvement in provision of safe drinking water, proper sanitation and hygiene promotion, cholera still remains a major public health problem in Malawi with outbreaks occurring almost every year since 1998. In response to 2014/2015 cholera outbreak, ministry of health and partners made a decision to assess the feasibility and acceptability of conducting a mass oral cholera vaccine (OCV) as an additional public health measure. This paper highlights the burden of the 2014/15 cholera outbreak, successes and challenges of OCV campaign conducted in March and April 2015. METHODS: This was a documentation of the first OCV campaign conducted in Malawi. The campaign targeted over 160,000 people aged one year or more living in 19 camps of people internally displaced by floods and their surrounding communities in Nsanje district. It was a reactive campaign as additional measure to improved water, sanitation and hygiene in response to the laboratory confirmed cholera outbreak. RESULTS: During the first round of the OCV campaign conducted from 30 March to 4 April 2015, a total of 156,592 (97.6%) people out of 160,482 target population received OCV. During the second round (20 to 25 April 2015), a total of 137,629 (85.8%) people received OCV. Of these, 108,247 (67.6%) people received their second dose while 29,382 (18.3%) were their first dose. Of the 134,836 people with known gender and sex who received 1 or 2 doses, 54.4% were females and over half (55.4%) were children under the age of 15 years. Among 108,237 people who received 2 doses (fully immunized), 54.4% were females and 51.9% were children under 15 years of age. No severe adverse event following immunization was reported. The main reason for non-vaccination or failure to take the 2 doses was absence during the period of the campaign. CONCLUSION: This documentation has demonstrated that it was feasible, acceptable by the community to conduct a large-scale mass OCV campaign in Malawi within five weeks. Of 320,000 OCV doses received, Malawi managed to administer at least 294,221 (91.9%) of the doses. OCV could therefore be considered to be introduced as additional measure in cholera hot spot areas in Malawi.

Magnitude of dental caries, missing and filled teeth in Malawi: National Oral Health Survey.

BACKGROUND: Oral health problems are significant cause of morbidity particularly in sub-Saharan Africa. In Malawi, routine health management information system data over the years showed that oral health problems were one of the top ten reasons for outpatient attendance. However, to date, no national oral survey has been carried out to determine the prevalence of oral health problems. METHODS: A national population-based cross-sectional survey was conducted in 2013. A total of 130 enumeration areas (EAs) were randomly selected and from each EA, 40 participants were randomly selected as per WHO STEPS survey protocol. Eligible participants were 12, 15, 35-44 and 65-74 year old. A multi-stage sampling design was used to obtain a national representative sample of these age groups. Oral examination was based on WHO diagnostic criteria (2010). RESULTS: A total of 5400 participants were enrolled in the survey. Of these: 3304 (61.3 %) were females, 2090 (38.7 %) were males; 327 (6.9 %) were from urban and 4386 (93.1 %) from rural areas; 1115 (20.6 %), 993 (17.3 %), 2306 (42.7 %) and 683 (12.6 %) were aged 12, 15, 35-44, 65-74 years respectively. Among 12 year-old, 15 year-old, 35-44 and 65-74 year age groups, prevalence of dental caries was 19.1, 21.9, 49.0 and 49.2 % respectively, overall 37.4 %. Prevalence of missing teeth was 2.7, 5.2, 47.7 and 79.9 %, overall 35.2 %. Prevalence of filled teeth was 0.2 %, 1.3 %, 8.7 %, 12.7 %, overall 6.5 %. Prevalence of bleeding gums was 13.0, 11.8, 30.8 and 36.1 %, overall 23.5 %. Toothache, dental caries and missing teeth were more common in females than males; 46.5 % vs 37.9 %, 40.5 % vs 32.4 %, 37.7 % vs 30.1 % respectively, all p < 0.05. Prevalence of dental caries and missing teeth in urban areas were as high as in the rural areas; 33.3 % vs 37.4 % and 30.9 % vs 33.7 % respectively, all p > 0.05. The mean number of decayed, missing and filled teeth (DMFT) in 12, 15, 35-44, 65-74 year old was 0.67, 0.71, 3.11 and 6.87 respectively. Self- reported brushing of teeth was poor with only 35.2 % of people brushed their teeth twice a day and tobacco smoking was high, particularly among adult males where one in five (22.9 %) was a smoker. CONCLUSION: This study demonstrated that oral health problems are major public health problems in Malawi. One in five (21 %) adolescents aged 12-15 years and half (49 %) of adults aged 35 years or more had dental caries, half (48 %) and 80 % of the population aged 35-44, 65-74 years had missing teeth respectively. Toothache, dental caries and missing teeth were more prevalent in females than males and prevalence in urban was as high as in rural areas. Oral hygiene was poor with less than 40 % of the population brush their teeth twice a day and tobacco smoking was high, particularly in men where prevalence was 23 %. These findings could be used to develop evidence-informed national policy, action and resource mobilization plan and community based interventions to reduce the prevalence of oral health problems in Malawi.

Prevalence and correlates of diabetes mellitus in Malawi: population-based national NCD STEPS survey.

BACKGROUND: Previously considered as a disease of the affluent, west or urban people and not of public health importance, diabetes mellitus is increasingly becoming a significant cause of morbidity and mortality in sub-Saharan Africa. However, population-based data to inform prevention, treatment and control are lacking. METHODS: Using the WHO STEPwise approach to chronic disease risk factor surveillance, a population-based, nationwide cross-sectional survey was conducted between July and September 2009 on participants aged 25-64 years. A multi-stage cluster sample design and weighting were used to produce a national representative data for that age range. Detailed findings on the magnitude of diabetes mellitus and impaired fasting blood glucose are presented in this paper. RESULTS: Fasting blood glucose measurement was conducted on 3056 participants (70.2% females, 87.9% from rural areas). The age- sex standardised population-based mean fasting blood glucose was 4.3 mmol/L (95% CI 4.1-4.4 mmol/L) with no significant differences by age, sex and location (urban/rural). The overall prevalence of impaired fasting blood glucose was 4.2% (95% CI 3.0%-5.4%). Prevalence of impaired blood glucose was higher in men than in women, 5.7% (95% CI 3.9%-7.5%) vs 2.7% (95% CI 1.6%- 3.8%), p < 0.01. In both men and women, prevalence of raised fasting blood glucose or currently on medication for diabetes was 5.6% (95% CI 2.6%- 8.5%). Although the prevalence of diabetes was higher in men than women, 6.5% (95% CI 2.6%-10.3%) vs 4.7% (95% CI 2.4%-7.0%), in rural than urban, 5.4% (95% CI 2.4%-8.4%) vs 4.4% (95% CI 2.8%-5.9%) and in males in rural than males in urban, 6.9% (95% CI 2.8%-11.0%) vs 3.2% (95% CI 0.1%-6.3%), the differences were not statistically significant, p > 0.05. Compared to previous estimates, prevalence of diabetes increased from <1.0% in 1960s to 5.6% in 2009 (this study). CONCLUSION: High prevalence of impaired fasting blood glucose and diabetes mellitus call for the implementation of primary healthcare approaches such as the WHO package for essential non-communicable diseases to promote healthy lifestyles, early detection, treatment and control.

Cholera outbreaks in Malawi in 1998-2012: social and cultural challenges in prevention and control.

INTRODUCTION: Cholera still remains a significant cause of morbidity and mortality in developing countries, although comprehensive surveillance data to inform policy and strategies are scarce. METHODOLOGY: A desk review of the national cholera database and zonal and districts reports was conducted. Interviews were conducted with district health management teams, health workers, and participants in communities in six districts affected by cholera in 2011/2012 to obtain data on water, sanitation, and sociocultural issues. RESULTS: From 1998 to 2012, cholera outbreaks occurred every year in Malawi, with the highest number of cases and deaths reported in 2001/2002 (33,546 cases, 968 deaths; case fatality rate [CFR] 2.3%). In 2011/2012, cholera outbreak was widespread in the southern region, affecting 10 out of 13 districts, where 1,806 cases and 38 deaths (CFR 2.1%) were reported. Unsafe water sources, lack of maintenance of broken boreholes, frequent breakdown of piped water supply, low coverage of pit latrines (range 40%-60%), lack of hand washing facilities (< 5%), salty borehole water, fishermen staying on Lake Chilwa, cross-border Malawi-Mozambique disease spread, and sociocultural issues were some of the causes of the persistent cholera outbreaks in Malawi. CONCLUSIONS: Despite improvements in safe drinking water and sanitation, cholera is still a major public health problem. Introduction of a community-led total sanitation approach, use of social and cultural information in community mobilization strategies, and introduction of an oral cholera vaccine could help to eliminate cholera in Malawi.

Cancer survival in Malawi: a retrospective cohort study.

INTRODUCTION: Cancer is a leading cause of morbidity and mortality worldwide with the burden in sub-Saharan Africa projected to double by year 2030 from 715,000 new cases and 542,000 deaths in 2008. However, cancer survival data to inform interventions for early detection, diagnosis and treatment are lacking. METHODS: Cancer survival analysis was conducted on 842 cancer patients registered and followed-up from 2006 to 2013 at NdiMoyo Palliative Care Centre in Salima District, central Malawi. Cancer survival was measured from the time of diagnosis. RESULTS: In both sexes, the common types of cancer were; Kaposi's sarcoma (KS) (48.0%), cervical cancer (21.1%), cancer of oesophagus (14.8%), liver cancer (3.1%) and breast cancer (2.5%). In Males; KS, cancer of the oesophagus, cancer of the liver, bone cancer and non-Hodgkin's lymphoma were the commonest accounting for 67.4%, 19.4%, 3.9%, 1.0% and 1.0% respectively. In females; cancer of the cervix, KS, cancer of the oesophagus, cancer of the breast and cancer of the liver were the top five cancers accounting for 41.6%, 29.2%, 10.3%, 4.9% and 2.3% respectively. Of the 830 cancer patients with complete 5-year follow-up data, the overall median survival time was 9 months. Absolute survival rates at 1, 2, 3, 4 and 5 years or more were 31.8%, 18.0%, 12.5%, 7.8% and 6.0% respectively. The survival rates for top five cancers at 1, 2, 3, and 4 years or more were; KS (n= 397): 47.1%, 30.2%, 21.4% and 13.1%; cancer of the cervix (n = 174): 31.0%, 10.3%, 5.2% and 2.9%; cancer of the oesophagus (n = 124): 4.0%, 2.4%, 1.6% and 1.6%; liver cancer (n = 26): 19.2%, 3.8%, 3.8% and 3.8% and breast cancer (n = 21): 9.5%, 0%, 0%, 0% respectively. The risk of death was high in females than males, in those aged 50 years or more than in those aged less than 50 (p < 0.05). CONCLUSION: This study demonstrated that cancer survival from the time of diagnosis in Malawi was poor with median survival time of about 9 months and only 6% of patients survived for 5 years or more. Improvement of early detection, diagnostic capability, access to treatment and palliative care services could improve cancer survival.

Burden of cancer in Malawi; common types, incidence and trends: national population-based cancer registry.

BACKGROUND: Cancer is a leading cause of morbidity and mortality worldwide with a majority of cases and deaths occurring in developing countries. While cancer of the lung, breast, colorectum, stomach and prostate are the most common types of cancer globally, in east and southern Africa these are less common and comprehensive data to inform policies are lacking. METHODS: Nationwide cancer registry was conducted between September and October 2010 in Malawi. New cancer cases registered from 2007 to 2010 were identified from hospital and clinic registers of 81 out of 84 health facilities providing cancer diagnosis, treatment or palliative care services. Demographic and cancer data were extracted from registers and case notes using a standard form. RESULTS: A total of 18,946 new cases of cancer were registered in Malawi from 2007-2010. Of these 55.9% were females, 7.2% were children aged less than 15 years, 76.5% were adults aged 15-59 years and 16.4% were elderly aged 60 years or more. Only 17.9% of the cases had histologically verified diagnosis, 33.2% were diagnosed clinically and 49.6% based on clinical and some investigations. Amongst females, cancer of the cervix was the commonest accounting for 45.4% of all cases followed by Kaposi sarcoma (21.1%), cancer of the oesophagus (8.2%), breast (4.6%) and non-Hodgkin lymphoma (4.1%). In males, Kaposi sarcoma was the most frequent (50.7%) then cancer of oesophagus (16.9%), non-Hodgkin lymphoma (7.8), prostate (4.0%) and urinary bladder (3.7%). Age-standardised incidence rate per 100,000 population for all types of cancer in males increased from 31 in 1999-2002 to 56 in 2007-2010. In females it increased from 29 to 69. Kaposi sarcoma and cancer of the oesophagus, cervical cancer and Kaposi sarcoma were the main causes for the increased incidence in males and females respectively. It was estimated that, annually at least 8,151 new cases of cancer (all types) occur in Malawi. CONCLUSIONS: This study provided data on common types and trends of cancer that could be used to focus prevention, treatment and control interventions in the context of limited resources. The problem of under-reporting and misdiagnosis of cancer cases has been highlighted.