Coverage outcomes (effects), costs, cost-effectiveness, and equity of two combinations of long-lasting insecticidal net (LLIN) distribution channels in Kenya: a two-arm study under operational conditions

Background: Malaria-endemic countries distribute long-lasting insecticidal nets (LLINs) through combined channels with ambitious, universal coverage (UC) targets. Kenya has used eight channels with variable results. To inform national decision-makers, this two-arm study compares coverage (effects), costs, cost-effectiveness, and equity of two combinations of LLIN distribution channels in Kenya. Methods: Two combinations of five delivery channels were compared as ‘intervention’ and ‘control’ arms. The intervention arm comprised four channels: community health volunteer (CHV), antenatal and child health clinics (ANCC), social marketing (SM) and commercial outlets (CO). The control arm consisted of the intervention arm channels except mass campaign (MC) replaced CHV. Primary analysis used random sample household survey data, service-provider costs, and voucher or LLIN distribution data to compare between-arm effects, costs, cost-effectiveness, and equity. Secondary analyses compared costs and equity by channel. Results: The multiple distribution channels used in both arms of the study achieved high LLIN ownership and use. The intervention arm had significantly lower reported LLIN use the night before the survey (84·8% [95% CI 83·0–86·4%] versus 89·2% [95% CI 87·8–90·5%], p < 0·0001), higher unit costs ($10·56 versus$7·17), was less cost-effective ($86·44, 95$75·77–$102·77 versus$69·20, 95% range $63·66–$77·23) and more inequitable (Concentration index [C.Ind] = 0·076 [95% CI 0·057 to 0·095 versus C.Ind = 0.049 [95% CI 0·030 to 0·067]) than the control arm. Unit cost per LLIN distributed was lowest for MC ($3·10) followed by CHV ($10·81) with both channels being moderately inequitable in favour of least-poor households. Conclusion: In line with best practices, the multiple distribution channel model achieved high LLIN ownership and use in this Kenyan study setting. The control-arm combination, which included MC, was the most cost-effective way to increase UC at household level. Mass campaigns, combined with continuous distribution channels, are an effective and cost-effective way to achieve UC in Kenya. The findings are relevant to other countries and donors seeking to optimise LLIN distribution. Trial registration: The assignment of the intervention was not at the discretion of the investigators; therefore, this study did not require registration

Controlled Human Malaria Infection in Semi-Immune Kenyan Adults (CHMI-SIKA): a study protocol to investigate in vivo Plasmodium falciparum malaria parasite growth in the context of pre-existing immunity [version 2; peer review: 2 approved]

Malaria remains a major public health burden despite approval for implementation of a partially effective pre-erythrocytic malaria vaccine. There is an urgent need to accelerate development of a more effective multi-stage vaccine. Adults in malaria endemic areas may have substantial immunity provided by responses to the blood stages of malaria parasites, but field trials conducted on several blood-stage vaccines have not shown high levels of efficacy. We will use the controlled human malaria infection (CHMI) models with malaria-exposed volunteers to identify correlations between immune responses and parasite growth rates in vivo. Immune responses more strongly associated with control of parasite growth should be prioritized to accelerate malaria vaccine development. We aim to recruit up to 200 healthy adult volunteers from areas of differing malaria transmission in Kenya, and after confirming their health status through clinical examination and routine haematology and biochemistry, we will comprehensively characterize immunity to malaria using >100 blood-stage antigens. We will administer 3,200 aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Challenge) by direct venous inoculation. Serial quantitative polymerase chain reaction to measure parasite growth rate in vivo will be undertaken. Clinical and laboratory monitoring will be undertaken to ensure volunteer safety. In addition, we will also explore the perceptions and experiences of volunteers and other stakeholders in participating in a malaria volunteer infection study. Serum, plasma, peripheral blood mononuclear cells and whole blood will be stored to allow a comprehensive assessment of adaptive and innate host immunity. We will use CHMI in semi-immune adult volunteers to relate parasite growth outcomes with antibody responses and other markers of host immunity. / Registration: ClinicalTrials.gov identifier NCT02739763

Clients&apos; perception of HIV/AIDS voluntary counseling and Testing (VCT) services in Nairobi, Kenya

ABSTRACT Objective: To assess clients&apos; perception of voluntary counseling and testing (VCT) services in Nairobi, Kenya. Methodology and results: Data was collected through self administered client exit questionnaires given to willing participants after going through the VCT centre and receiving the services. The questionnaires were developed and supplied by NASCOP. Convenient sampling of the questionnaires was done and only those completed between May and August 2003 were purposively selected. A sample size of 110 was achieved from available client exit interview forms. Data analysis involved generating frequencies and cross tabulations among the variables that addressed perception disaggregated by gender. Regardless of gender, the clients&apos; perception under the key thematic areas scored over 90%. Conclusion and application of findings: The findings of the survey underscored the professional manner with which NASCOP implemented the recruitment, training and supervision of VCT counselors. It also confirmed that there has been thorough vetting of potential VCT sites prior to registration, to ensure they meet the minimum set standards for accreditation. While significant progress has been made in developing the monitoring and evaluation systems in health care in Kenya, the challenge of satisfying the ever changing needs of clients persists. The NASCOP client exit interview questionnaire was a good tool for collecting immediate feedback on clients from VCT clients. However, some modifications are required to address some inherent limitations of the questionnaire, e.g. it did not disaggregate responses by important variables that could have informed the survey better

Correlation of burn injury and family history of burns among patients hospitalized at a public hospital in Nairobi, Kenya: A case–control study

Introduction: Burn injuries are physically and psychologically devastating types of trauma and are common among children especially in the home environment. They are more prevalent and are a public health problem in developing countries principally because of poor socioeconomic conditions. Effective prevention programs should be tailored for specific geographic locations and guided by the results of well-designed studies aimed at investigating local risk factors for burns. Studies targeting households can result in the identification of risk factors operating within family setups. Study Objective: To determine the association between occurrence of burn injury and family history of burns among patients hospitalized at a large hospital in a developing country in Africa. Methodology: This was age- and gender-matched case–control study comprising 202 patients admitted with burns (cases) and 202 nonsurgical patients (controls) admitted into the pediatric and medical wards. The study site was Kenyatta National Hospital, an 1800-bed national referral and teaching hospital in Kenya. The dependent variable was burn injury whereas the independent variables were family history of burn injury, history of hospitalization, and presence of a burn injury scar in the burnt family member. History of hospitalization following burn injury was termed as an indicator of severe burn injury having been sustained. Data Analytical Methods: The Chi-square test was used to identify the differences between the cases and control group variables, and logistic regression analysis and odds ratio were done to determine the relationship between the dependent and independent variables. Results: The male:female ratio was found to be 1:1, and burn injuries were found to be most common in the 0–4 years age bracket (n = 86, 42.6%), with the second most common age bracket being 20–40 years (n = 78, 38.6%). The injuries were mainly sustained in homes (n = 161, 80.9%) and the remainder at work (n = 15, 7.5%) and other places (n = 23, 11.6%). There was no significant difference between the two groups with regard to family history of burns (odds ratio [OR] = 0.689, 95% confidence interval [CI]: 0.443–1.073, P = 0.062) and presence of a burn scar in previously burnt family members (OR = 1.083, 95% CI: 0.308–3.805, P = 1.0). There was, however, a statistically significant higher incidence of postburn injury hospitalizations among the cases than the controls (OR = 2.354, 95% CI: 1.064–5.208, P = 0.033). Conclusion: Family history of burn injury with hospitalization of those affected is an indicator of households at a higher risk for burn injuries. More of the cases had history of hospitalization for burn injury among their family members, indicating that they had more risk factors operating within their environment, or their practices made them more prone to burn injuries. Identification of the specific risk factors involved is key in the prevention of burn injuries in homes

Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders.

BACKGROUND: Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and appropriately accounted for. Building on earlier work, we embedded social science research within an ongoing malaria human infection study in coastal Kenya to understand the study benefits and burdens experienced by study stakeholders in this low-resource setting and assess the wider implications for future research planning and policy. METHODS: Data were collected using qualitative research methods, including in-depth interviews (44), focus group discussions (10) and non-participation observation. Study participants were purposively selected (key informant or maximal diversity sampling), including volunteers in the human infection study, study staff, community representatives and local administrative authorities. Data were collected during and up to 18 months following study residency, from sites in Coastal and Western Kenya. Voice recordings of interviews and discussions were transcribed, translated, and analysed using framework analysis, combining data- and theory-driven perspectives. FINDINGS: Physical, psychological, economic and social forms of benefits and burdens were experienced across study stages. Important benefits for volunteers included the study compensation, access to health checks, good residential living conditions, new learning opportunities, developing friendships and satisfaction at contributing towards a new malaria vaccine. Burdens primarily affected study volunteers, including experiences of discomfort and ill health; fear and anxiety around aspects of the trial process, particularly deliberate infection and the implications of prolonged residency; anxieties about early residency exit; and interpersonal conflict. These issues had important implications for volunteers' families, study staff and the research institution's reputation more widely. CONCLUSION: Developing ethically and scientifically strong HIS relies on grounded accounts of volunteers, study staff and the wider community, understood in the socioeconomic, political and cultural context where studies are implemented. Recognition of the diverse, and sometimes perverse, nature of potential benefits and burdens in a given context, and who this might implicate, is critical to this process. Prior and ongoing stakeholder engagement is core to developing these insights

Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders

Background Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and appropriately accounted for. Building on earlier work, we embedded social science research within an ongoing malaria human infection study in coastal Kenya to understand the study benefits and burdens experienced by study stakeholders in this low-resource setting and assess the wider implications for future research planning and policy. Methods Data were collected using qualitative research methods, including in-depth interviews (44), focus group discussions (10) and non-participation observation. Study participants were purposively selected (key informant or maximal diversity sampling), including volunteers in the human infection study, study staff, community representatives and local administrative authorities. Data were collected during and up to 18 months following study residency, from sites in Coastal and Western Kenya. Voice recordings of interviews and discussions were transcribed, translated, and analysed using framework analysis, combining data- and theory-driven perspectives. Findings Physical, psychological, economic and social forms of benefits and burdens were experienced across study stages. Important benefits for volunteers included the study compensation, access to health checks, good residential living conditions, new learning opportunities, developing friendships and satisfaction at contributing towards a new malaria vaccine. Burdens primarily affected study volunteers, including experiences of discomfort and ill health; fear and anxiety around aspects of the trial process, particularly deliberate infection and the implications of prolonged residency; anxieties about early residency exit; and interpersonal conflict. These issues had important implications for volunteers’ families, study staff and the research institution’s reputation more widely. Conclusion Developing ethically and scientifically strong HIS relies on grounded accounts of volunteers, study staff and the wider community, understood in the socioeconomic, political and cultural context where studies are implemented. Recognition of the diverse, and sometimes perverse, nature of potential benefits and burdens in a given context, and who this might implicate, is critical to this process. Prior and ongoing stakeholder engagement is core to developing these insights

HIV sero-prevalence among tuberculosis patients in Kenya

Objective: To determine HIV seroprevalence among tuberculosis patients and the burden of HlV attributable tuberculosis among notified patients in Kenya.Design: A cross-sectional anonymous unlinked HlV seroprevalence survey.Setting: Tuberculosis diagnostic clinics of the National Leprosy Tuberculosis Programme in 19 districts.Subjects: One thousand nine hundred and fifty two newly notified tuberculosis patients.Interventions: Selection and registration of eligible subjects followed by obtaining 5ml of full blood for haemoglobin testing and separation of serum for HIV testing by ELISA.Main outcome measures: HlV seroprevalence per district and burden of HIV attributable tuberculosis among tuberculosis patients.Results: A total of 1,952 eligible patients were ended. The weighted seroprevalence in the sample was 40.7% (range 11.8-79.6% per district). The seroprevalence was significantly higher among females and patients with sputum-smear negative tuberculosis. Chronic diarrhoea, female sex, oral thrush and a negative sputum were independent risk factors for HIV infection. The Odds ratio for HIV infection in female tuberculosis patients aged 15-44 years, was 5.6 (95% CI 4.5-6.9) compared with ante-natal clinic attenders. The population attributable risk was 0.22 in 1994.Conclusion: The HlV epidemic has had a profound impact on the tuberculosis epidemic in Kenya and explains about 41% of the 94.5% increase of registered patients in the period 1990-1994 and 20% of all registered patients in 1994. Repetition of the survey with inclusion of a more representative control group from the general population may provide a more accurate estimation of the burden of HIV attributable tuberculosis