Browsing by Author "Chilengi, Roma"

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A mobile phone-based, community health worker program for referral, follow-up, and service outreach in rural Zambia: outcomes and overview.
(2014-Aug) Schuttner, Linnaea; Sindano, Ntazana; Theis, Matthew; Zue, Cory; Joseph, Jessica; Chilengi, Roma; Chi, Benjamin H.; Stringer, Jeffrey S.; Chintu, Namwinga
BACKGROUND: Mobile health (m-health) utilizes widespread access to mobile phone technologies to expand health services. Community health workers (CHWs) provide first-level contact with health facilities; combining CHW efforts with m-health may be an avenue for improving primary care services. As part of a primary care improvement project, a pilot CHW program was developed using a mobile phone-based application for outreach, referral, and follow-up between the clinic and community in rural Zambia. MATERIALS AND METHODS: The program was implemented at six primary care sites. Computers were installed at clinics for data entry, and data were transmitted to central servers. In the field, using a mobile phone to send data and receive follow-up requests, CHWs conducted household health surveillance visits, referred individuals to clinic, and followed up clinic patients. RESULTS: From January to April 2011, 24 CHWs surveyed 6,197 households with 33,304 inhabitants. Of 15,539 clinic visits, 1,173 (8%) had a follow-up visit indicated and transmitted via a mobile phone to designated CHWs. CHWs performed one or more follow-ups on 74% (n=871) of active requests and obtained outcomes on 63% (n=741). From all community visits combined, CHWs referred 840 individuals to a clinic. CONCLUSIONS: CHWs completed all planned aspects of surveillance and outreach, demonstrating feasibility. Components of this pilot project may aid clinical care in rural settings and have potential for epidemiologic and health system applications. Thus, m-health has the potential to improve service outreach, guide activities, and facilitate data collection in Zambia.
A phase 2b randomized, controlled trial of the efficacy of the GMZ2 malaria vaccine in African children.
(2016-Aug-31) Sirima, Sodiomon B.; Mordmüller, Benjamin; Milligan, Paul; Ngoa, Ulysse A.; Kironde, Fred; Atuguba, Frank; Tiono, Alfred B.; Issifou, Saadou; Kaddumukasa, Mark; Bangre, Oscar; Flach, Clare; Christiansen, Michael; Bang, Peter; Chilengi, Roma; Jepsen, Søren; Kremsner, Peter G.; Theisen, Michael
BACKGROUND: GMZ2 is a recombinant protein malaria vaccine, comprising two blood-stage antigens of Plasmodium falciparum, glutamate-rich protein and merozoite surface protein 3. We assessed efficacy of GMZ2 in children in Burkina Faso, Gabon, Ghana and Uganda. METHODS: Children 12-60months old were randomized to receive three injections of either 100μg GMZ2 adjuvanted with aluminum hydroxide or a control vaccine (rabies) four weeks apart and were followed up for six months to measure the incidence of malaria defined as fever or history of fever and a parasite density ⩾5000/μL. RESULTS: A cohort of 1849 children were randomized, 1735 received three doses of vaccine (868 GMZ2, 867 control-vaccine). There were 641 malaria episodes in the GMZ2/Alum group and 720 in the control group. In the ATP analysis, vaccine efficacy (VE), adjusted for age and site was 14% (95% confidence interval [CI]: 3.6%, 23%, p-value=0.009). In the ITT analysis, age-adjusted VE was 11.3% (95% CI 2.5%, 19%, p-value=0.013). VE was higher in older children. In GMZ2-vaccinated children, the incidence of malaria decreased with increasing vaccine-induced anti-GMZ2 IgG concentration. There were 32 cases of severe malaria (18 in the rabies vaccine group and 14 in the GMZ2 group), VE 27% (95% CI -44%, 63%). CONCLUSIONS: GMZ2 is the first blood-stage malaria vaccine to be evaluated in a large multicenter trial. GMZ2 was well tolerated and immunogenic, and reduced the incidence of malaria, but efficacy would need to be substantially improved, using a more immunogenic formulation, for the vaccine to have a public health role.
A pilot study on use of live attenuated rotavirus vaccine (Rotarix™) as an infection challenge model.
(2020-Oct-27) Chilengi, Roma; Simuyandi, Michelo; Chibuye, Mwelwa; Chirwa, Masuzyo; Sukwa, Nsofwa; Laban, Natasha; Chisenga, Caroline; Silwamba, Suwilanji; Grassly, Nicholas; Bosomprah, Samuel
BACKGROUND: Rotavirus remains the commonest cause of dehydrating diarrhoea, particularly in developing countries. Human infection challenge studies in children in these countries offers an opportunity to rapidly evaluate new vaccine candidates that may have improved efficacy. We evaluated use of Rotarix™ as a live-attenuated challenge agent. METHODS: We undertook an open label, exploratory study in infants receiving two standard doses of Rotarix™ at 6 and 10 weeks of age in a cohort of 22 Zambian infants. The first vaccine dose was considered as primary vaccination, and the second at day 28 as a live-attenuated virus challenge. Saliva, stool and serum samples were collected on days 0, 3, 5, 7, 14, and 28 following each dose. The primary outcome was stool shedding of rotavirus, determined by NSP2 qPCR. We calculated mean shedding index as average of natural logarithm of viral copies per gram of stool. FINDINGS: After the first dose, viral shedding was high at day 3, peaked by day 5. After the second dose, viral shedding at day 3 was low and reduced gradually in most infants until day 14. Mean shedding index was significantly lower post dose 2 across all infants and timepoints (5.0 virus copies/g of stool [95%CI: 0.3-9.7] vs 10.4 virus copies/g of stool [95%CI: 6.2-14.6]; p-value < 0.0001; rho = 0.20, SD = 4.97. Seroconversion at day 28 was associated with a mean reduction of -1.03 (95%CI = -8.07, 6.01) in viral shedding after challenge dose but this was not statistically significant (p = 0.774). A borderline positive correlation between fold-change in IgA titre at day 28 from day 0 in saliva and serum was observed; Spearman's correlation coefficient, r = 0.69; p = 0.086. INTERPRETATION: Shedding after the 'challenge' dose was reduced compared with the first dose, consistent with the induction of mucosal immunity by the first dose. This supports the use of Rotarix vaccine as a live-attenuated infection challenge. FUNDING: Medical Research Council (UK) through the HIC-Vac Network.
A Preliminary Assessment of Rotavirus Vaccine Effectiveness in Zambia.
(2016-May-01) Beres, Laura K.; Tate, Jacqueline E.; Njobvu, Lungowe; Chibwe, Bertha; Rudd, Cheryl; Guffey, Brad M.; Stringer, Jeffrey S.; Parashar, Umesh D.; Chilengi, Roma
BACKGROUND: Diarrhea is the third leading cause of child death in Zambia. Up to one-third of diarrhea cases resulting in hospitalization and/or death are caused by vaccine-preventable rotavirus. In January 2012, Zambia initiated a pilot introduction of the Rotarix live, oral rotavirus vaccine in all public health facilities in Lusaka Province. METHODS: Between July 2012 and October 2013, we conducted a case-control study at 6 public sector sites to estimate rotavirus vaccine effectiveness (VE) in age-eligible children presenting with diarrhea. We computed the odds of having received at least 1 dose of Rotarix among children whose stool was positive for rotavirus antigen (cases) and children whose stool was negative (controls). We adjusted the resulting odds ratio (OR) for patient age, calendar month of presentation, and clinical site, and expressed VE as (1 - adjusted OR) × 100. RESULTS: A total of 91 rotavirus-positive cases and 298 rotavirus-negative controls who had under-5 card-confirmed vaccination status and were ≥6 months of age were included in the case-control analysis. Among rotavirus-positive children who were age-eligible to be vaccinated, 20% were hospitalized. Against rotavirus diarrhea of all severity, the adjusted 2-dose VE was 26% (95% confidence interval [CI], -30% to 58%) among children ≥6 months of age. VE against hospitalized children ≥6 months of age was 56% (95% CI, -34% to 86%). CONCLUSIONS: We observed a higher point estimate for VE against increased severity of illness compared with milder disease, but were not powered to detect a low level of VE against milder disease.
Assessing capacity and readiness to manage NCDs in primary care setting: Gaps and opportunities based on adapted WHO PEN tool in Zambia.
(2018) Mutale, Wilbroad; Bosomprah, Samuel; Shankalala, Perfect; Mweemba, Oliver; Chilengi, Roma; Kapambwe, Sharon; Chishimba, Charles; Mukanu, Mulenga; Chibutu, Daniel; Heimburger, Douglas
INTRODUCTION: Sub-Saharan Africa is experiencing an epidemiological transition as the burden of NCDs overtake communicable diseases. However, it is unknown what capacity and gaps exist at primary care level to address the growing burden of NCDs. This study aimed to assess the Zambian health system's capacity to address in NCDs, using an adapted WHO Essential Non Communicable Disease Interventions (WHO PEN) tool. METHODOLOGY: This was a cross-sectional facility survey in the three districts conducted from September 2017 to October 2017. We defined facility readiness along five domains: basic equipment, essential services, diagnostic capacity, counseling services, and essential medicines. For each domain, we calculated an index as the mean score of items expressed as percentage. These indices were compared to an agreed cutoff at 70%, meaning that a facility index or district index below 70% off was considered as 'not ready' to manage NCDs at that level. All analysis were performed using Stata 15 MP. RESULTS: There appeared to be wide heterogeneity between facilities in respect of readiness to manage NCDs. Only 6 (including the three 1st level hospitals) out of the 46 facilities were deemed ready to manage NCDs. Only the first level hospitals scored a mean index higher than the 70% cut off; With regard to medications needed to manage NCDs, urban and rural health facilities were comparably equipped. However, there was evidence that calcium channel blockers (p = 0.013) and insulin (p = 0.022) were more likely to be available in urban and semi-urban health facilities compared to rural facilities. CONCLUSION: Our study revealed gaps in primary health care capacity to manage NCDs in Zambia, with almost all health facilities failing to reach the minimum threshold. These results could be generalized to other similar districts in Zambia and the sub-region, where health systems remain focused on infectious rather than non-communicable Disease. These results should attract policy attention and potentially form the basis to review current approach to NCD care at the primary care level in Zambia and Sub-Saharan Africa.
Association of Maternal Immunity with Rotavirus Vaccine Immunogenicity in Zambian Infants.
(2016) Chilengi, Roma; Simuyandi, Michelo; Beach, Lauren; Mwila, Katayi; Becker-Dreps, Sylvia ; Emperador, Devy M.; Velasquez, Daniel E.; Bosomprah, Samuel; Jiang, Baoming
INTRODUCTION: Live attenuated oral vaccines against rotavirus (RV) have been shown to be less efficacious in children from developing countries. Reasons for this disparity are not fully understood. We assessed the role of maternal factors including breast milk RV-specific IgA, transplacentally acquired infant serum RV-specific IgG and maternal HIV status in seroconversion among Zambian infants routinely immunized with Rotarix™ (RV1). METHODS: 420 mother-child pairs were recruited at infant age 6-12 weeks in Lusaka. Clinical information and samples were collected at baseline and at one month following the second dose of RV1. Determination of breast milk RV-specific IgA and serum RV-specific IgA and IgG was done using standardized ELISA. Seroconversion was defined as a ≥ 4 fold rise in serum IgA titre from baseline to one-month post RV1 dose 2, while seropositivity of IgA was defined as serum titre ≥ 40 and antibody variables were modelled on log-base 2. Logistic regression was used to identify predictors of the odds of seroconversion. RESULTS: Baseline infant seropositivity was 25.5% (91/357). The seroconversion frequency was 60.2% (130/216). Infants who were IgA seropositive at baseline were less likely to seroconvert compared to their seronegative counterparts (P = 0.04). There was no evidence of an association between maternal HIV status and seroconversion (P = 0.25). Higher titres of breast milk rotavirus-specific IgA were associated with a lower frequency of seroconverson (Nonparametric test for trend Z = -2.84; P<0.01): a two-fold increase in breast milk RV-specific IgA titres was associated with a 22% lower odds of seroconversion (OR = 0.80; 95% CI = 0.68-0.94; P = 0.01). There was seasonal variation in baseline breast milk rotavirus-specific IgA titres, with significantly higher GMTs during the cold dry months (P = 0.01). CONCLUSION: Low immunogenicity of RV1 vaccine could be explained in part by exposure to high antibody titres in breast milk and early exposure to wild-type rotavirus infections. Potential interference of anti-RV specific IgA in breast milk and pre-vaccination serum RV specific-IgA and IgG titres with RV1 seroconversion and effectiveness requires further research.
Associations between health systems capacity and mother-to-child HIV prevention program outcomes in Zambia.
(2018) Price, Joan T.; Chi, Benjamin H.; Phiri, Winifreda M.; Ayles, Helen; Chintu, Namwinga; Chilengi, Roma; Stringer, Jeffrey S. A.; Mutale, Wibroad
INTRODUCTION: Zambia has made substantial investments in health systems capacity, yet it remains unclear whether improved service quality improves outcomes. We investigated the association between health system capacity and use of prevention of mother-to-child HIV transmission (PMTCT) services in Zambia. MATERIALS AND METHODS: We analyzed data from two studies conducted in rural and semi-urban Lusaka Province in 2014-2015. Health system capacity, our primary exposure, was measured with a validated balanced scorecard approach. Based on WHO building blocks for health systems strengthening, we derived overall and domain-specific facility scores (range: 0-100), with higher scores indicating greater capacity. Our outcome, community-level maternal antiretroviral drug use at 12 months postpartum, was measured via self-report in a large cohort study evaluating PMTCT program impact. Associations between health systems capacity and our outcome were analyzed via linear regression. RESULTS: Among 29 facilities, median overall facility score was 72 (IQR:67-74). Median domain scores were: patient satisfaction 75 (IQR 71-78); human resources 85 (IQR:63-87); finance 50 (IQR:50-67); governance 82 (IQR:74-91); service capacity 77 (IQR:68-79); service provision 60 (IQR:52-76). Our programmatic outcome was measured from 804 HIV-infected mothers. Median community-level antiretroviral use at 12 months was 81% (IQR:69-89%). Patient satisfaction was the only domain score significantly associated with 12-month maternal antiretroviral use (β:0.22; p = 0.02). When we excluded the human resources and finance domains, we found a positive association between composite 4-domain facility score and 12-month maternal antiretroviral use in peri-urban but not rural facilities. CONCLUSIONS: In these Zambian health facilities, patient satisfaction was positively associated with maternal antiretroviral 12 months postpartum. The association between overall health system capacity and maternal antiretroviral drug use was stronger in peri-urban versus rural facilities. Additional work is needed to guide strategic investments for improved outcomes in HIV and broader maternal-child health region-wide.
Awareness and management of elevated blood pressure among human immunodeficiency virus-infected adults receiving antiretroviral therapy in urban Zambia: a call to action.
(2017) Bauer, Sophie; Wa Mwanza, Mwanza; Chilengi, Roma; Holmes, Charles B.; Zyambo, Zude; Furrer, Hansjakob; Egger, Matthias; Wandeler, Gilles; Vinikoor, Michael J.
The prevalence of high blood pressure (HBP) and hypertension (HTN), awareness of the diagnoses, and use of anti-hypertensive drugs were examined among human immunodeficiency virus (HIV)-infected individuals on antiretroviral therapy (ART) in Zambia's capital Lusaka. Within a prospective cohort based at two public sector ART clinics, BP was measured at ART initiation and every 6 months thereafter as a routine clinic procedure. Predictors of HBP (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) during one year on ART were analyzed using logistic regression, and the proportion with HTN (2+ episodes of HBP >3 months apart) described. A phone survey was used to understand patient awareness of HBP, use of anti-hypertensive drugs, and history of cardiovascular events (CVE; myocardial infarction or stroke). Among 896 cohort participants, 887 (99.0%) had at least one BP measurement, 98 (10.9%) had HBP, and 57 (6.4%) had HTN. Increasing age (10-year increase in age: adjusted odds ratio [AOR] = 1.50; 95% confidence interval [CI] 1.20-1.93), male sex (AOR = 2.33, 95% CI 1.43-3.80), and overweight/obesity (AOR = 4.07; 95% CI 1.94-8.53) were associated with HBP. Among 66 patients with HBP, 35 (53.0%) reported awareness of the condition, and nine (25.7%) of these reported having had a CVE. Only 14 (21.2%) of those reached reported ever taking an anti-hypertensive drug, and one (1.5%) was currently on treatment. These data suggest that major improvements are needed in the management of HBP among HIV-infected individuals in settings such as Zambia.
Chronic hepatitis B virus monoinfection at a university hospital in Zambia.
(2018-Sep-27) Vinikoor, Michael J.; Sinkala, Edford; Kanunga, Annie; Muchimba, Mutinta; Nsokolo, Bright; Chilengi, Roma; Wandeler, Gilles; Mulenga, Joseph; Chisenga, Tina; Bhattacharya, Debika; Saag, Michael S.; Foster, Graham; Fried, Michael W.; Kelly, Paul
AIM: To characterize antiviral therapy eligibility among hepatitis B virus (HBV)-infected adults at a university hospital in Zambia. METHODS: Hepatitis B surface antigen-positive adults ( RESULTS: The median age was 33 years, 71.9% were men, and 30.9% were diagnosed with HBV through a clinically-driven test with the remainder identified CONCLUSION: Approximately one in ten HBV-monoinfected Zambians were eligible for antivirals. Many had indeterminate phenotype and needed clinical follow-up.
Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study.
(2017) Gitaka, Jesse; Ogwang, Caroline; Ngari, Moses; Akoo, Pauline; Olotu, Ally; Kerubo, Christine; Fegan, Greg; Njuguna, Patricia; Nyakaya, Godfrey; Otieno, Tuda; Mwambingu, Gabriel; Awuondo, Ken; Lowe, Brett; Chilengi, Roma; Berkley, James A.
Reference intervals for clinical laboratory parameters are important for assessing eligibility, toxicity grading and management of adverse events in clinical trials. Nonetheless, haematological and biochemical parameters used for clinical trials in sub-Saharan Africa are typically derived from industrialized countries, or from WHO references that are not region-specific. We set out to establish community reference values for haematological and biochemical parameters amongst children aged 4 weeks to 17 months in Kilifi, Kenya. We conducted a cross sectional study nested within phase II and III trials of RTS, S malaria vaccine candidate. We analysed 10 haematological and 2 biochemical parameters from 1,070 and 423 community children without illness prior to experimental vaccine administration. Statistical analysis followed Clinical and Laboratory Standards Institute EP28-A3c guidelines. 95% reference ranges and their respective 90% confidence intervals were determined using non-parametric methods. Findings were compared with published ranges from Tanzania, Europe and The United States. We determined the reference ranges within the following age partitions: 4 weeks to <6 months, 6 months to less than <12 months, and 12 months to 17 months for the haematological parameters; and 4 weeks to 17 months for the biochemical parameters. There were no gender differences for all haematological and biochemical parameters in all age groups. Hb, MCV and platelets 95% reference ranges in infants largely overlapped with those from United States or Europe, except for the lower limit for Hb, Hct and platelets (lower); and upper limit for platelets (higher) and haematocrit(lower). Community norms for common haematological and biochemical parameters differ from developed countries. This reaffirms the need in clinical trials for locally derived reference values to detect deviation from what is usual in typical children in low and middle income countries.
Clinical presentation of congenital syphilis in a rotavirus vaccine cohort study in Lusaka: a case series.
(2021-Apr-01) Sukwa, Nsofwa; Simuyandi, Michelo; Chirwa, Masuzyo; Kumwimba, Yvonne M.; Chilyabanyama, Obvious N.; Laban, Natasha ; Koyuncu, Aybüke; Chilengi, Roma
BACKGROUND: Despite an otherwise robust national antenatal clinic program, maternal and congenital syphilis remains an important public health issue in Zambia. This case series reports the clinical presentation of seven infants diagnosed with congenital syphilis in Lusaka, Zambia. CASE PRESENTATIONS: The cases in this series were incidental findings from a cohort of infants enrolled in a rotavirus vaccine immunogenicity study recruiting infants at 6 weeks of age. As part of clinical care for enrolled participants, we screened mothers of children who presented with adverse events of (i) repeated upper respiratory tract infections/coryza, (ii) skin lesions, and (iii) poor weight gain, for syphilis using rapid plasma reagin test. From a cohort of 214 mother-infant pairs enrolled between September and December 2018, a total of 115 (44.4%) of the mothers reported to have not been screened during antenatal care. Of these, four (3.5%) reported to have tested positive; and only two received treatment. Seven out of 57 (26.6%) children meeting the screening criteria had a positive rapid plasma reagin test result. The mean age at diagnosis was 4.5 months (1.3 months standard deviation), and the common presenting features included coryza (6/7), skin lesions (4/7), conjunctivitis (3/7), pallor/anemia (5/7), wasting (2/7), and underweight (5/7). Three of the seven infants were exposed to human immunodeficiency virus. Following diagnosis, all seven cases received standard treatment according to national treatment guidelines. That is, 6/7 cases received inpatient care with benzylpenicillin for 10 days, while 1/7 was treated as an outpatient and received daily procaine penicillin for 10 days. CONCLUSION: These findings suggest that, though screening for syphilis is part of the standard antenatal care in Zambia, it is not offered optimally. There is urgent need to address programmatic shortcomings in syphilis screening and treatment to avoid long-term sequelae. Additionally, clinicians need to raise their index of suspicion and rule out syphilis when confronted with these clinical symptoms, regardless of the mother's human immunodeficiency virus status.
Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries.
(2017-Jan) Mwila, Katayi; Chilengi, Roma; Simuyandi, Michelo; Permar, Sallie R.; Becker-Dreps, Sylvia
The role of maternal immunity, received by infants either transplacentally or orally from breast milk, in rotavirus vaccine (RV) performance is evaluated here. Breastfeeding withholding has no effect on vaccine responses, but higher levels of transplacental rotavirus-specific IgG antibody contribute to reduced vaccine seroconversion. The gaps in knowledge on the factors associated with low RV efficacy in low- and middle-income countries (LMIC) remain, and further research is needed to shed more light on these issues.
Costs of introducing pneumococcal, rotavirus and a second dose of measles vaccine into the Zambian immunisation programme: Are expansions sustainable?
(2016-Jul-29) Griffiths, Ulla K.; Bozzani, Fiammetta M.; Chansa, Collins; Kinghorn, Anthony; Kalesha-Masumbu, Penelope ; Rudd, Cheryl; Chilengi, Roma; Brenzel, Logan; Schutte, Carl
BACKGROUND: Introduction of new vaccines in low- and lower middle-income countries has accelerated since Gavi, the Vaccine Alliance was established in 2000. This study sought to (i) estimate the costs of introducing pneumococcal conjugate vaccine, rotavirus vaccine and a second dose of measles vaccine in Zambia; and (ii) assess affordability of the new vaccines in relation to Gavi's co-financing and eligibility policies. METHODS: Data on 'one-time' costs of cold storage expansions, training and social mobilisation were collected from the government and development partners. A detailed economic cost study of routine immunisation based on a representative sample of 51 health facilities provided information on labour and vaccine transport costs. Gavi co-financing payments and immunisation programme costs were projected until 2022 when Zambia is expected to transition from Gavi support. The ability of Zambia to self-finance both new and traditional vaccines was assessed by comparing these with projected government health expenditures. RESULTS: 'One-time' costs of introducing the three vaccines amounted to US$ 0.28 per capita. The new vaccines increased annual immunisation programme costs by 38%, resulting in economic cost per fully immunised child of US$ 102. Co-financing payments on average increased by 10% during 2008-2017, but must increase 49% annually between 2017 and 2022. In 2014, the government spent approximately 6% of its health expenditures on immunisation. Assuming no real budget increases, immunisation would account for around 10% in 2022. Vaccines represented 1% of government, non-personnel expenditures for health in 2014, and would be 6% in 2022, assuming no real budget increases. CONCLUSION: While the introduction of new vaccines is justified by expected positive health impacts, long-term affordability will be challenging in light of the current economic climate in Zambia. The government needs to both allocate more resources to the health sector and seek efficiency gains within service provision.
Data-driven quality improvement in low-and middle-income country health systems: lessons from seven years of implementation experience across Mozambique, Rwanda, and Zambia.
(2017-Dec-21) Wagenaar, Bradley H.; Hirschhorn, Lisa R.; Henley, Catherine; Gremu, Artur; Sindano, Ntazana; Chilengi, Roma
BACKGROUND: Well-functioning health systems need to utilize data at all levels, from the provider, to local and national-level decision makers, in order to make evidence-based and needed adjustments to improve the quality of care provided. Over the last 7 years, the Doris Duke Charitable Foundation's African Health Initiative funded health systems strengthening projects at the facility, district, and/or provincial level to improve population health. Increasing data-driven decision making was a common strategy in Mozambique, Rwanda and Zambia. This paper describes the similar and divergent approaches to increase data-driven quality of care improvements (QI) and implementation challenge and opportunities encountered in these three countries. METHODS: Eight semi-structured in-depth interviews (IDIs) were administered to program staff working in each country. IDIs for this paper included principal investigators of each project, key program implementers (medically-trained support staff, data managers and statisticians, and country directors), as well as Ministry of Health counterparts. IDI data were collected through field notes; interviews were not audio recorded. Data were analyzed using thematic analysis but no systematic coding was conducted. IDIs were supplemented through donor report abstractions, a structured questionnaire, one-on-one phone calls, and email exchanges with country program leaders to clarify and expand on key themes emerging from IDIs. RESULTS: Project successes ranged from over 450 collaborative action-plans developed, implemented, and evaluated in Mozambique, to an increase from <10% to >80% of basic clinical protocols followed in intervention facilities in rural Zambia, and a shift from a lack of awareness of health data among health system staff to collaborative ownership of data and using data to drive change in Rwanda. CONCLUSION: Based on common successes across the country experiences, we recommend future data-driven QI interventions begin with data quality assessments to promote that rapid health system improvement is possible, ensure confidence in available data, serve as the first step in data-driven targeted improvements, and improve staff data analysis and visualization skills. Explicit Ministry of Health collaborative engagement can ensure performance review is collaborative and internally-driven rather than viewed as an external "audit."
Disentangling the effects of a multiple behaviour change intervention for diarrhoea control in Zambia: a theory-based process evaluation.
(2017-Oct-17) Greenland, Katie; Chipungu, Jenala; Chilekwa, Joyce; Chilengi, Roma; Curtis, Val
BACKGROUND: Diarrhoea is a leading cause of child death in Zambia. As elsewhere, the disease burden could be greatly reduced through caregiver uptake of existing prevention and treatment strategies. We recently reported the results of the Komboni Housewives intervention which tested a novel strategy employing motives including affiliation and disgust to improve caregiver practice of four diarrhoea control behaviours: exclusive breastfeeding; handwashing with soap; and correct preparation and use of oral rehydration salts (ORS) and zinc. The intervention was delivered via community events (women's forums and road shows), at health clinics (group session) and via radio. A cluster randomised trial revealed that the intervention resulted in a small improvement in exclusive breastfeeding practices, but was only associated with small changes in the other behaviours in areas with greater intervention exposure. This paper reports the findings of the process evaluation that was conducted alongside the trial to investigate how factors associated with intervention delivery and receipt influenced caregiver uptake of the target behaviours. METHODS: Process data were collected from the eight peri-urban and rural intervention areas throughout the six-month implementation period and in all 16 clusters 4-6 weeks afterwards. Intervention implementation (fidelity, reach, dose delivered and recruitment strategies) and receipt (participant engagement and responses, and mediators) were explored through review of intervention activity logs, unannounced observation of intervention events, semi-structured interviews, focus groups with implementers and intervention recipients, and household surveys. Evaluation methods and analyses were guided by the intervention's theory of change and the evaluation framework of Linnan and Steckler. RESULTS: Intervention reach was lower than intended: 39% of the surveyed population reported attending one or more face-to-face intervention event, of whom only 11% attended two or more intervention events. The intervention was not equally feasible to deliver in all settings: fewer events took place in remote rural areas, and the intervention did not adequately penetrate communities in several peri-urban sites where the population density was high, the population was slightly higher socio-economic status, recruitment was challenging, and numerous alternative sources of entertainment existed. Adaptations made by the implementers affected the fidelity of implementation of messages for all target behaviours. Incorrect messages were consequently recalled by intervention recipients. Participants were most receptive to the novel disgust and skills-based interactive demonstrations targeting exclusive breastfeeding and ORS preparation respectively. However, initial disgust elicitation was not followed by a change in associated psychological mediators, and social norms were not measurably changed. CONCLUSIONS: The lack of measured behaviour change was likely due to issues with both the intervention's content and its delivery. Achieving high reach and intensity in community interventions delivered in diverse settings is challenging. Achieving high fidelity is also challenging when multiple behaviours are targeted for change. Further work using improved tools is needed to explore the use of subconscious motives in behaviour change interventions. To better uncover how and why interventions achieve their measured effects, process evaluations of complex interventions should develop and employ frameworks for investigation and interpretation that are structured around the intervention's theory of change and the local context. TRIAL REGISTRATION: The study was registered as part of the larger trial on 5 March 2014 with ClinicalTrials.gov: NCT02081521 .
Early linear growth retardation: results of a prospective study of Zambian infants.
(2019-Jan-14) Chilengi, Roma; Asombang, Mah; Kadota, Jillian L.; Chilyabanyama, Obvious N.; Mwila-Kazimbaya, Katayi; Ng'ombe, Harriet; Simuyandi, Michelo; Bosomprah, Samuel
BACKGROUND: Linear growth retardation is the most dominant nutritional problem globally. We aimed to describe linear growth trajectory among infants under 2 years of age using the WHO growth velocity standards. METHOD: This was a prospective cohort study of infants enrolled at 6 weeks of age and followed up for up to 24 months in Kamwala Urban Health Centre, Lusaka, Zambia. The study was conducted between April 2013 and March 2015. Infants were enrolled if they were 6-12 weeks of age and the mother was willing to participate voluntarily and provided informed consent. Anthropometric data were collected at scheduled clinic visits at 1 month, 2 months, 3 months, then quarterly until the infant was 24 months old. We defined linear growth velocity as the rate of change in height. We estimated linear growth velocity as the first derivative of the penalized cubic spline mixed effects model. RESULTS: A total of 338 children were included in the analysis. Of these, 185 (54.7%) were female, 115 (34.1%) were born to HIV positive mothers and thus classified as HIV Exposed (HE). The mean age of children at enrollment was 1.6 months (SD = 0.15). On average, the growth velocity for 3-month length increments conditional on age were 0-3 months = 2.97 cm/3mo (95%CI = 2.69, 3.25); 3-6 months = 2.62 cm/3mo (95%CI = 2.38, 2.87); 6-9 months = 1.57 cm/3mo (95%CI = 1.43, 1.71); 9-12 months = 1.18 cm/3mo (95%CI = 1.08, 1.28); 12-15 month = 1.14 cm/3mo (95%CI = 1.02, 1.27); 15-18 months = 0.87 cm/3mo (95%CI = 0.79, 0.96); 18-21 months = 0.80 cm/3mo (95%CI = 0.72, 0.89); and 21-24 months = 0.86 cm/3mo (95%CI = 0.77, 0.96). For both boys and girls, the growth velocity in our cohort were consistently below the 3rd percentile of the WHO linear growth velocity standard. The estimated mean height and the age at which growth begins to falter were 68.6 cm (95%CI = 68.0, 69.2) and 13.6 months (95%CI = 13.2, 14.1) respectively. CONCLUSION: We found slower rate of growth among otherwise healthy Zambian infants. The data suggests that growth retardation is universal and profound in this cohort and may have already been occurring in utero.
Effect of a behaviour change intervention on the quality of peri-urban sanitation in Lusaka, Zambia: a randomised controlled trial.
(2019-Apr) Tidwell, James B.; Chipungu, Jenala; Bosomprah, Samuel; Aunger, Robert; Curtis, Val; Chilengi, Roma
BACKGROUND: Poor sanitation in peri-urban areas is a growing public health problem. We tested a scalable, demand-side behaviour change intervention to motivate landlords to improve the quality of shared toilets within their plots. METHODS: We did a residential plot-randomised controlled trial in a peri-urban community in Lusaka, Zambia. We enrolled adult resident landlords on plots where at least one tenant lived. We allocated landlords 1:1 to intervention and control arms on the basis of a random number sequence. The intervention was developed using the Behaviour Centred Design approach and consisted of a series of group meetings designed to motivate sanitation quality improvement as a way to build wealth and reduce on-plot conflict; no subsidies or materials were provided. The control group received no intervention. The four primary outcomes were having a rotational cleaning system in place (to improve hygiene); having a solid door on the toilet used by tenants with an inside lock (for privacy); having an outside lock (for security); and having a sealed toilet (to reduce smell and contamination). We measured outcomes 1 month before the start of the intervention and 4 months after the end of the intervention. Data collectors measuring outcomes were blinded to group assignment. We analysed outcomes by intention to treat, including all landlords with study-end results. Because the outcomes were assumed to not be independent, we used a family-wise error rate of 0·05 to calculate an adjusted significance level of 0·0253. This study was registered with ClinicalTrials.gov, number NCT03174015. FINDINGS: Between June 9 and July 6, 2017, 1085 landlords were enrolled and randomly assigned to the intervention (n=543) or the control group (n=542). The intervention was delivered from Aug 1, 2017, and evaluated from Feb 15 to March 5, 2018. Analysis was based on the 474 intervention and 454 control landlords surveyed at study end. The intervention was associated with improvements in the prevalence of cleaning rotas (relative risk 1·16, 95% CI 1·05-1·30; p=0·0011), inside locks (1·34, 1·10-1·64; p=0·00081), outside locks (1·27, 1·06-1·52; p=0·0028), and toilets with simple covers or water seals (1·25, 1·04-1·50; p=0·0063). INTERPRETATION: It is possible to improve the structural quality and cleanliness of shared sanitation by targeting landlords with a scalable, theory-driven behaviour change intervention without subsidy or provision of the relevant infrastructure. FUNDING: Sanitation and Hygiene Applied Research for Equity.
Effect of innate antiviral glycoproteins in breast milk on seroconversion to rotavirus vaccine (Rotarix) in children in Lusaka, Zambia.
(2017) Mwila-Kazimbaya, Katayi; Garcia, Miguel P.; Bosomprah, Samuel; Laban, Natasha M.; Chisenga, Caroline C.; Permar, Sallie R.; Simuyandi, Michelo; Munsaka, Sody; Chilengi, Roma
INTRODUCTION: Rotavirus vaccines have been introduced into national immunization programmes to mitigate morbidity and mortality associated rotavirus diarrhoea. Lower vaccine effectiveness has however been noted in low-middle income countries, but little is known about the role of maternal components found in breast milk. This study assessed the effect of lactoferrin, lactadherin, and tenascin-c on rotavirus vaccine seroconversion. METHODS: This was a retrospective cohort study of 128 infants who had been fully immunized with Rotarix™. Serum samples were collected from the infant at baseline and one month after second rotavirus vaccine dose. Breast milk samples were collected from mothers at baseline. Standard ELISA was used to determine titres of rotavirus-specific immunologlobulin G and A in breast milk and serum as well as concentrations of lactoferrin, lactadherin, and tenascin-c. Poisson regression model with robust standard error was used to estimate the effect of breast milk components on seroconversion. The components were modelled on log base 2 so that the effect would be interpreted as a doubling of the concentration. RESULTS: In a multivariable analysis adjusting for maternal age, maternal HIV status, seropositivity at baseline, sex, age of child at vaccination as well as breast milk IgA and IgG, we found evidence of independent effect of LA (Adjusted IRR = 0.95; 95% CI = 0.91-0.99; P = 0.019) on seroconversion while there was no evidence for TNC (Adjusted IRR = 1.00; 95% CI = 0.85-1.17; P = 0.967) and LF (Adjusted RR = 1.01; 95% CI = 0.96-1.05); P = 0.802). We explored the joint effects of the three components but we found no evidence (Adjusted RR = 0.95; 95% CI = 0.81; P = 0.535). CONCLUSION: High breast milk concentrations of lactadherin might play a role in infant's failure to seroconvert to rotavirus vaccines. Further research to understand this observed association is an important consideration.
Enterotoxigenic Escherichia coli (ETEC) vaccines: Priority activities to enable product development, licensure, and global access.
(2021-Jul-13) Khalil, Ibrahim; Walker, Richard; Porter, Chad K.; Muhib, Farzana; Chilengi, Roma; Cravioto, Alejandro ; Guerrant, Richard; Svennerholm, Ann-Mari ; Qadri, Firdausi; Baqar, Shahida; Kosek, Margaret; Kang, Gagandeep; Lanata, Claudio; Armah, George; Wierzba, Thomas; Hasso-Agopsowicz, Mateusz; Giersing, Birgitte; Bourgeois, Louis A.
Diarrhoeal disease attributable to enterotoxigenic Escherichia coli (ETEC) causes substantial morbidity and mortality predominantly in paediatric populations in low- and middle-income countries. In addition to acute illness, there is an increasing appreciation of the long-term consequences of enteric infections, including ETEC, on childhood growth and development. Provision of potable water and sanitation and appropriate clinical care for acute illness are critical to reduce the ETEC burden. However, these interventions are not always practical and may not achieve equitable and sustainable coverage. Vaccination may be the most cost-effective and equitable means of primary prevention; however, additional data are needed to accelerate the investment and guide the decision-making process for ETEC vaccines. First, to understand and quantify the ETEC disease burden, additional data are needed on the association between ETEC infection and physical and cognitive stunting as well as delayed educational attainment. Furthermore, the role of inappropriate or inadequate antibiotic treatment of ETEC-attributable diarrhoea may contribute to the development of antimicrobial resistance (AMR) and needs further elucidation. An ETEC vaccine that mitigates acute diarrhoeal illness and minimizes the longer-term disease manifestations could have significant public health impact and be a cost-effective countermeasure. Herein we review the ETEC vaccine pipeline, led by candidates compatible with the general parameters of the Preferred Product Characteristics (PPC) recently developed by the World Health Organization. Additionally, we have developed an ETEC Vaccine Development Strategy to provide a framework to underpin priority activities for researchers, funders and vaccine manufacturers, with the goal of addressing globally unmet data needs in the areas of research, product development, and policy, as well as commercialization and delivery. The strategy also aims to guide prioritization and co-ordination of the priority activities needed to minimize the timeline to licensure and use of ETEC vaccines, especially in in low- and middle-income countries, where they are most urgently needed.
Evaluating the costs of cholera illness and cost-effectiveness of a single dose oral vaccination campaign in Lusaka, Zambia.
(2019) Tembo, Tannia; Simuyandi, Michelo; Chiyenu, Kanema; Sharma, Anjali; Chilyabanyama, Obvious N.; Mbwili-Muleya, Clara; Mazaba, Mazyanga L.; Chilengi, Roma
INTRODUCTION: In 2016, for the very first time, the Ministry of Health in Zambia implemented a reactive outbreak response to control the spread of cholera and vaccinated at-risk populations with a single dose of Shancol-an oral cholera vaccine (OCV). This study aimed to assess the costs of cholera illness and determine the cost-effectiveness of the 2016 vaccination campaign. METHODOLOGY: From April to June 2017, we conducted a retrospective cost and cost-effectiveness analysis in three peri-urban areas of Lusaka. To estimate costs of illness from a household perspective, a systematic random sample of 189 in-patients confirmed with V. cholera were identified from Cholera Treatment Centre registers and interviewed for out-of-pocket costs. Vaccine delivery and health systems costs were extracted from financial records at the District Health Office and health facilities. The cost of cholera treatment was derived by multiplying the subsidized cost of drugs by the quantity administered to patients during hospitalisation. The cost-effectiveness analysis measured incremental cost-effectiveness ratio-cost per case averted, cost per life saved and cost per DALY averted-for a single dose OCV. RESULTS: The mean cost per administered vaccine was US$1.72. Treatment costs per hospitalized episode were US$14.49-US$18.03 for patients ≤15 years old and US$17.66-US$35.16 for older patients. Whereas households incurred costs on non-medical items such as communication, beverages, food and transport during illness, a large proportion of medical costs were borne by the health system. Assuming vaccine effectiveness of 88.9% and 63%, a life expectancy of 62 years and Gross Domestic Product (GDP) per capita of US$1,500, the costs per case averted were estimated US$369-US$532. Costs per life year saved ranged from US$18,515-US$27,976. The total cost per DALY averted was estimated between US$698-US$1,006 for patients ≤15 years old and US$666-US$1,000 for older patients. CONCLUSION: Our study determined that reactive vaccination campaign with a single dose of Shancol for cholera control in densely populated areas of Lusaka was cost-effective.