bluuebunny/crossref_metadata_2025 huggingface dataset:
UNDERSTANDING PATIENT DECISIONS TO TRANSFER OR DISENGAGE FROM HIV CARE AND TREATMENT IN ZAMBIA
Authors: Topp Stephanie , Mwamba Chanda , Beres Laura , Padian Nancy , Sikazwe Izukanji , Geng Elvin , Holmes Charles
Published: February 2017

Background

Despite widespread roll-out of free HIV care and treatment (C&T), large numbers of HIV-positive Zambians are disengaged from care. Nested within a 4-province study of HIV C&T outcomes, we explored how interactions between system hardware (tangible components) and system software (normative & behavioural components) at the service-delivery level influenced patients' decision to transfer or disengage from care.

Methods

In-depth interviews were conducted with a stratified random sample of 75 HIV-infected adults from 4 provinces and five patient categories: currently in-care, pregnant in-care, disengaged, transferred (to another facility), friend/ family of deceased patient. Sixteen focus group discussions were convened with lay and professional healthcare workers (HCW) providers serving the same catchment areas. Audio transcripts were translated, transcribed and subject to deductive and inductive analysis guided by a modified social-ecological framework.

Results

Health system ‘hardware’ factors influencing patient decisions included distance and chronic understaffing that resulted in long wait-times and administrative mistakes (e.g. loss of patient records). Health system ‘software’ factors included various aspects of clinic organisational culture. Examples are limited consideration of HCWs of the way employment or family circumstances affected patients' ability to adhere to protocol-driven treatment schedules and a harmful power dynamic that compelled patients to ‘humble’ themselves and ‘obey’ HCWs to avoid being ‘punished’. Described by many as a problem of HCWs ‘lacking heart’ or ‘having a bad attitude’, these phenomena were often linked to experiences of disrespect and/or abuse that influenced decisions to transfer or leave C&T.

Conclusions

Findings demonstrate a dynamic and compounding effect of health system ‘hardware’ and ‘software’ factors on decisions to transfer/disengage. Data suggest a need for: i) improvements in physical resourcing and structuring of HIV services; ii) a move away from exclusively static clinic-based service models and iii) revisions to policy enabling a re-orientation of pre-service training, clinic leadership and workplace incentives to encourage health-promoting, person-centred care.
A CROSS-SECTIONAL STUDY OF HEPATITIS B VIRUS INFECTION IN HIV-INFECTED CHILDREN IN WINDHOEK, NAMIBIA
Authors: Tamandjou Cynthia , Kaindjee-Tjituka Francina , Brandt Laura , Cotton Mark , Nel Etienne , Preiser Wolfgang , Andersson Monique
Published: February 2017

Background

Hepatitis B virus (HBV) remains endemic in Africa and an important co-morbidity in the HIV epidemic. The HIV treatment guidelines of the World Health Organisation (WHO) recommend tenofovir−lamivudine (or emtricitabine) as first-line therapy for HIV−HBV co-infection management in children ≥10 years old. However, many children in sub-Saharan Africa are not screened for HBV and may remain on lamivudine monotherapy for many years. This study aimed to characterise HBV infection in HIV-infected children in Namibia.

Methods

The study included HIV-infected/HBsAg-positive children, exposed to lamivudine monotherapy, attending the Katutura paediatric HIV clinic in Windhoek, Namibia. Dried blood spots and serum samples were collected from participants. Serological investigations were performed using Murex assays. HBV DNA viral load was determined using the automated AmpliPrep/COBAS TaqMan HBV test V2.0. Genotyping and mutation analysis were performed through the NCBI HBV Genotyping tool (www.ncbi.nlm.nih.gov/ projects/genotyping/formpage.cgi) and Geno2Pheno (http:// hbv.geno2pheno.org/index.php).

Results

To date, 14 children have been enrolled; of whom 14 DBS and 11 serum samples were analysed. HBsAg was detected in 10 children (90%; 10/11); 7 were HBeAg-positive/HBeAb-negative and 3 HBeAg-negative. Among HBeAg-negatives, 1 was HBeAb-negative and 2 were HBeAb-positive. One child was non-reactive for all markers. Of the 14 children, 7(50%) tested HBV DNA-positive. Lamivudine drug-associated resistance variants, together with immune escape mutants in the overlapping surface gene, were identified in these children. Resistance mutation patterns included:rtV173L+rtL180M+rt-M204V (4/7; 57%),rtL80I+rtV173L+rtL180M+rtM204I (1/7; 14%) andrtL180M+rtM204V (2/7; 29%); with the overlappingsE164D and/orsI195M variants. HBV strains belonged to genotype E (6/7, 86%) and genotype D3 (1/7, 14%).

Conclusions

Half of the children included in this study had detectable HBV DNA and showed lamivudine resistance. Uncontrolled HBV infection is associated with an increased risk of severe liver damage and hepatocellular carcinoma. HBsAg screening of HIV-infected children, using cost-effective point-of-care methods, and treatment with tenofovir should be made more widely available in resource-limited settings.
FEASIBILITY OF USING THE LYNX POINT-OF-CARE TEST FOR EARLY INFANT HIV DIAGNOSIS IN RURAL ZAMBIA
Authors: Chilikwazi Mutinta , Sutcliffe Catherine , Thuma Philip , Sinywimaanzi Kathy , Matakala Hellen , Munachoonga Passwell , Moss William
Published: February 2017

Background

Early infant diagnosis of HIV is challenging in sub-Saharan Africa, particularly in rural areas, leading to delays in diagnosis and treatment. A point-of-care test would overcome many challenges. This study was undertaken to evaluate the feasibility of implementing a point-of-care p24 antigen detection test (LYNX) in rural Zambia.

Methods

A cross-sectional study of infants attending the Macha Hospital HIV or primary care clinics for early infant diagnosis was conducted in Choma district, Southern Province, Zambia during 2014 and 2015. Two blood samples were collected from each participant, one for immediate testing with the LYNX test and a second for standard HIV DNA testing at a central laboratory. Counsellors were trained to perform the LYNX test and observed for adherence to protocols.

Results

A total of 210 LYNX tests were performed; 93% of tests were run according to protocol with a result available with a median time of 55 minutes (IQR:54, 57); 10% of tests were run on battery power. The median turnaround time for the availability of the HIV DNA test result was 2.5 months (IQR: 1.8, 5.0). The sensitivity and specificity of the LYNX test were 70% and 100%, respectively. Challenges to implementation included the long duration of the LYNX test and multiple steps, disruption of other daily activities, and managing variable patient volumes.

Conclusions

Point-of-care tests for early infant diagnosis are urgently needed to increase access to testing. The LYNX test was successfully performed by counsellors and had several characteristics facilitating implementation in rural clinics. The LYNX test could address many challenges to testing in rural areas and allow for earlier diagnosis and treatment of HIV-infected infants, therefore improving outcome.
UPTAKE OF ANTIRETROVIRAL THERAPY AMONG HIV-INFECTED PREGNANT WOMEN AND ITS IMPACT ON HIV MOTHER-TO-CHILD TRANSMISSION IN MBEYA, TANZANIA
Authors: Masenza Issa Sabi , Geisenberger Otto , Agrea Peter , Maboko Leonard , Rwegoshora France , Mahiga Hellen , Olomi Willyhelmina , Hoelscher Michael , Kroidl Arne
Published: February 2017

Background

Maternal viral load (VL) and immunological status are important risk factors for mother-to-child transmission of HIV. In line with WHO recommendations (Option B+), Tanzania introduced the initiation of life long antiretroviral therapy (ART) in pregnant women in 2013. We present the uptake of ART and its impact on mother-to-child transmission.

Methods

Between July 2015 and June 2016 data were obtained from HIV-infected pregnant women participating in the ongoing BABY Study (ClinicalTrials.gov Identifier:NCT02545296), which evaluates point-of-care testing in HIV Early Infant Diagnosis (HEID). Women were enrolled at the time of delivery, and neonates were followed-up until 6 weeks post-partum. Maternal HIV-RNA was assessed at delivery; neonatal HIV diagnosis was performed using the Cepheid Xpert point-of-care test and confirmed by qualitative dry blood spot HIV-DNA (Roche COBAS TaqMan).

Results

In total 415 HIV-infected pregnant women were enrolled (median age 29 years). Nearly all women had attended antenatal care (96.4%); in 245 (59%) HIV was first diagnosed during pregnancy, and in 63.8% ART was initiated within 1 week following diagnosis. At the time of delivery 368 (88.7%) women were on ART, HIV-RNA >1000 copies/mL were detected in 78 (18.9%) and a CD4 count <200 cells/µL in 63 (15.2%). The overall mother-to-child HIV transmission rate was 2.4% (10/415) and 7/10 neonates were HIV diagnosed at the time of birth correctly identified by point-of-care testing. HIV-RNA >1000 copies/ml irrespectively of ART and low CD4 count <200 cells/μL were associated with higher risk of neonatal HIV transmission.

Conclusions

Despite the implementation of life-long ART in all pregnant women, reduction of HIV transmission from mother to child is still sub-optimal. High HIV-RNA as the main risk factor for HIV transmission irrespective of maternal ART points to the need for maternal VL screening during the antenatal period.
DEVELOPMENT AND EVALUATION OF A MULTIMEDIA TOOL FOR OBTAINING INFORMED CONSENT IN THE GAMBIA: A MIXED METHOD STUDY
Authors: Afolabi Muhammed , Mcgrath Nuala , D'Alessandro Umberto , Kampmann Beate , Imoukhuede Egeruan , Ravinetto Raffaella , Alexander Neal , Larson Heidi , Chandramohan Daniel , Bojang Kalifa
Published: February 2017

Background

Communicating crucial research information to low-literacy research participants in Africa is highly challenging in the context of several factors which make the participants vulnerable to poor comprehension of consent information. We previously developed and validated a digitised audio comprehension questionnaire. Here, we report the development and evaluation of a multimedia consent tool amongst low-literacy participants in The Gambia.

Methods

Adults eligible for inclusion in a malaria treatment trial (n=311) were randomised to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm).

A computerised audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups.

Results

On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (p=0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% CI: 0.12 –0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13–0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16–0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand.

Conclusions

A customised multimedia tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy in The Gambia. Further evaluation of the tool is warranted in similar settings.
IMPACT OF A HOLISTIC INTERVENTION ON PMTCT UPTAKE WITHIN SUB-SAHARAN AFRICA: EVIDENCE FROM ‘SAVE THE FAMILIES FOR AFRICA’ IN MALAWI
Authors: Fokam Joseph , Santoro Maria-Mercedes , Musolo Chrissie , Chimbiri Isabel , Chikwenga Gloria , Deula Ruth , Massari Riccardo , Lungu Agness , Perno Carlo-Federico
Published: February 2017

Background

Prevention of mother-to-child transmission (PMTCT) option B+ makes effective the virtual elimination of HIV (<5%) among African children effective. Some major challenges remain, such as accessibility to PMTCT-services and male-partner involvement. To improve PMTCT-interventions/expansion, we evaluated PMTCT-service uptakes within a typical African context, using a holistic approach.

Methods

As part of monitoring and evaluation of the ‘Save the Families for Africa’, a comparative assessment of PMTCT-uptake was conducted within the Likuni Mission Hospital catchment area in Likuni, Malawi. Four performance indicators were measured before (July-November 2015) and during (December 2015-May 2016) project-interventions: i) HIV-infected pregnant women enrolled for antenatal care (ANC)/PMTCT-services; ii) HIV-related deliveries at the hospital; iii) male-partner involvement into PMTCT; iv) PMTCT community-outreach interventions. Comparison was performed using Mann-Whitney test (p< 0.05 considered significant).

Results

During project-interventions, provision of free coupons for ANC/PMTCT-related services (including CD4/ Haemoglobin point-of-care monitoring) and for nutritional supplements, invitation notes and counselling intensification for male-partners, as well as provision of a mobile unit (new ambulance) for PMTCT-services expansion to remote/rural communities, were implemented. Overall, target performances appeared to increase over time after interventions. Indeed, the total number of women enrolled before intervention was 58, and sharply increased thereafter (182). The median [interquartile] number of HIV-infected pregnant women enrolled per month for ANC/PMTCT-services was doubled (beforevsduring: 11[10–13]vs26[22–43], p=0.0043); HIV-related deliveries per month increased 12 times [11–13]vs17[11–22], p=0.3160); male-partner involvement to PMTCT per month became effective [0%vs23.1%[9.3–33.3%], p=0.0260); PMTCT community-outreach per month increased by 12 fold (1[0–2]vs12[6–14], p=0.0286). Maternal mortality and HIV-vertical transmission were 0% throughout project-interventions.

Conclusions

Our findings highlight that there is room for improvement of PMTCT, starting from option B+, by implementing a holistic interventional model. This can greatly contribute to eliminating MTCT and in ameliorating the well-being of the entire family (children, mother and father) living with HIV/AIDS in sub-Saharan Africa.
CURRENT PATTERNS AND PREDICTIVE TRENDS OF MULTIDRUG-RESISTANTSALMONELLA TYPHIIN SUDAN
Authors: Elshayeb Ayman , Siddig Marmar El , Ahmed Abdel Azim , Hussien Adil El
Published: February 2017

Background

Enteric fever has a persistently great impact on public health. It is caused bySalmonella entericaassociated with malaria during the rainy season; the bacterium is seldom detected in wastewater of stabilisation stations due to treatment processes. The aim of this study is to evaluate the recent state of antibiotics susceptibility ofSalmonella typhiwith special attention to multidrug-resistant strains and predict the emergence of new resistance patterns.

Methods

S. typhiisolates were recovered from 128 wastewater samples collected from ponds at Soba Stabilization Station and Omdurman Hospital Stabilization Station. The isolates were identified using standardSalmonellaidentification guidelines and their susceptibility to seven antibiotics was determined. Minimum inhibitory concentration (MIC) of ciprofloxacin and minimum bactericidal concentrations (MBC) were also determined. Statistical predictions for the resistance emergence were done using logistic regression and forecasting linear equations.

Results

A total of 12S. typhiisolated strains were recovered from 128 samples of wastewater; they were resistant to antibiotics except Ciprofloxacin. Current patterns of ciprofloxacin breakpoints interpretations were in susceptible ranges by disc diffusion (S≥20 mm), minimum inhibitory concentration was recorded as (I=16 µg/ml) and minimum bactericidal concentration=(R≥32 µg/ml). The probability of an isolate to develop resistance was plotted for MBCs; the rate of resistance solved by (y=0.0235×−0.0411). The predictive patterns of resistance were spontaneously solved using exponential trend (y=n ex) for each isolate at 16 µg/ml and 32 µg/ml of ciprofloxacin in certain period and the high values of coefficient R2>0.5 indicate the incidence rates of bacterial resistance.

Conclusions

The current sensitivity patterns ofS. typhiisolates against ciprofloxacin were acceptable, but the probability of emerging multidrug resistance to ciprofloxacin was observed in sensitivity which had begun to decline according to frequent consuming, drug policy and bacterial genetic mutations.
AETIOLOGY, ANTIBIOTIC RESISTANCE AND RISK FACTORS FOR NEONATAL SEPSIS IN A LARGE REFERRAL CENTRE IN ZAMBIA
Authors: Kabwe Mwila , Tembo John , Chilukutu Lophina , Chilufya Moses , Ngulube Francis , Lukwesa Chileshe , Enne Virve , Wexner Hannah , Mwananyanda Lawrence , Hamer Davidson , Sinyangwe Sylvester , Ahmed Yusuf , Klein Nigel , Maeurer Markus , Zumla Ali , Bates Matthew
Published: February 2017

Background

In sub-Saharan Africa there is scanty data on the causes of neonatal sepsis and antimicrobial resistance among common invasive pathogens, which might guide policy and practice.

Methods

This was a cross-sectional observational prevalence and aetiology study of neonates with suspected sepsis admitted to the neonatal intensive care unit, University Teaching Hospital, Lusaka, Zambia, between October 2013 and May 2014. Data from blood cultures and phenotypic antibiotic susceptibility testing were compared with multivariate analysis of risk factors for neonatal sepsis.

Results

Of 313 neonates with suspected sepsis, 54% (170/313) were male; 20% (62/313) were born to HIV-positive mothers; 33% (103/313) had positive blood cultures, of which 85% (88/103) were early onset sepsis (EOS).Klebsiellaspecies was the most prevalent isolate, accounting for 75% (77/103) of cases, followed by coagulase-negative staphylococci (6% (7/103)),Staphylococcus aureus(6% (6/103)),Escherichia coli(5% (5/103) andCandidaspecies (5% (5/103). ForKlebsiellaspecies, antibiotic resistance ranged from 96–99% for WHO-recommended first-line therapy (gentamicin and ampicillin/penicillin) to 94–97% for third generation cephalosporins. The prevalence of culture-confirmed sepsis increased from 0–39% from December 2013 to March 2014, during which time mortality increased 29–47%. 93% (14/15) neonates with late onset sepsis and 82% (37/45) with early-onset sepsis aged 4–7 days were admitted >2 days prior to onset of symptoms. Culture results for only 25% (26/103) of cases were available before discharge or death. Maternal HIV infection was associated with a reduced risk of neonatal sepsis (OR 0.46 [0.23–0.93], p=0.029).

Conclusions

Outbreaks of nosocomial multi-antibiotic-resistant infections are an important cause of neonatal sepsis and associated mortality. Reduced risk of neonatal sepsis associated with maternal HIV infection is counterintuitive and requires further investigation.
RESISTANCE OF ENTEROPATHOGENS MAINLY ASSOCIATED WITH DIARRHOEA TO FREQUENTLY PRESCRIBED ANTIBIOTICS IN KOUSSERI (FAR NORTH, CAMEROON)
Authors: Beyala Landry , Etienne Guenou , Anthony Njimbia , Benjamin Azike , Ateudjieu Jerome
Published: February 2017

Background

The resistance of diarrhoea-causing enteropathogens to antibiotics is a global concern.

Methods

A cross-sectional descriptive study that had as objective to test the sensitivity of these pathogens to antibiotics frequently prescribed in the Logone and Chari Division was carried out in Kousseri from 24 July to 23 October 2015. Stool samples were collected from patients (children and adults) presenting at the Kousseri Annex Regional Hospital, in sterile containers and analysed as required by SOPs in the cholera detection laboratory of the NGO ‘Better Access to Health Care’ (BAHCARE) in Kousseri. Microbial isolation and identification was done using Hektoen and EMB culture media and API 20E pack (Biomerieux). Antibiotic susceptibility testing was done using the Kirby Bauer method with Muller Hinton medium.

Results

A total of 150 stool samples were analysed, out of which 45 enteropathogens were isolated (66% of isolated microbes wereEscherichia coli), identified and tested with antibiotic discs. The rate of resistance ofEscherichia coliwas 83.33% to cotrimoxazole and 43.33% to both ceftriaxone and ciprofloxacin. Salmonella species had a resistance rate of 71.42%, 42.86%, and 28.57% to cotrimoxazole, ceftriaxone and ciprofloxacine, respectively.Shigella sppwere 100% resistant to cotrimoxazole, ciprofloxacine and the combination of amoxicillin with clavulanic acid.

Conclusions

These results underscore the need to systematically assess the sensitivity of enteropathogens to antibiotics so as to guide health workers on the prescription of antibiotics in the Lake Chad area, Cameroon.
LOCALLY DRIVEN RESEARCH IS BETTER FOR INFECTIOUS DISEASES OUTBREAK PREPAREDNESS: AN EDCTP CAPACITY-BUILDING PROJECT IN POST-EBOLA LIBERIA
Authors: Tarr Christine Attia , Perez Guillermo Martinez , Omeonga Senga , Kibungu Fanta , Meyer Ana , Lansana Peter , Mayor Alfredo
Published: February 2017

Background

Liberia is recovering from an Ebola outbreak. Liberia suffers from brain drain and a low gross enrolment ratio in tertiary education alongside a dearth of institutions, skilled investigators and funds for research. Liberia needs to rebuild its capacity in epidemiological research. The Saint Joseph's Catholic Hospital (SJCH) in Monrovia –in collaboration with ISGlobal and the Juan Ciudad Foundation, received an EDCTP grant to strengthen its staff capacities to lead research in infectious diseases.

Methods

In March 2016, a participatory planning process started. The hospital management team and medical department staff were engaged. The process was guided by scientists from ISGlobal. Thirty-two trainees were identified among staff of the Ministry of Health and SJCH; community leaders were sought to build a Community Advisory Board; and trainees' suggestions informed the design of a 6-months Moodle-based eLearning program.

Results

Two workshops on Good Clinical and Laboratory Practices (GCLP) were conducted. In preparation for the SJCH to conduct biomedical research and clinical trials, another workshop to design Standard Operating Procedures was done. All trainees joined the eLearning program and received a certificate of completion. Furthermore, the SJCH defined its own institutional research program, submitted a research proposal to a local ethics board, and is pooling resources to undertake further research on infectious diseases in 2017.

Conclusions

A collaborative multi-disciplinary framework that promoted participation of the community was an approach that fuelled the successful completion of all training activities of this EDCTP-awarded project. The trainees capitalised on their experiences during the Ebola epidemic to ensure all activities were planned as per best quality standards. All trainees were motivated to prevent that planning and implementation-related errors they witnessed during the Ebola outbreak, were repeated in new education and research initiatives. In addressing global health challenges today, these motivational driving forces need a responsible and prompt response from Northern countries.
THE ROLE OF LOCAL CONTRACT RESEARCH ORGANISATIONS IN BUILDING GCP-COMPLIANT CLINICAL RESEARCH IN POVERTY-RELATED DISEASES IN AFRICA: A CASE OF CLINWIN RESEARCH SERVICES
Authors: Onyango Peter
Published: February 2017

Background

Africa carries the largest burden of the poverty-related diseases in the world. Most of her populations live in resource-limited settings. These act as catalysts for poverty-related diseases in those populations. There is urgent need for affordable, safe and effective health technologies to reduce the economic burden of those diseases. Clinical research provides an opportunity for access to new and improved health technologies, which have undergone evaluation in clinical trial settings, in compliance with Good Clinical Practice (GCP) and local regulatory requirements. The local Contract Research Organisations offer cost-effective solutions, human resource capacity and experience in poverty-related diseases research, regulatory affairs, culture and politics.

Methods

ClinWin provides clinical development services for poverty-related diseases. It has partnered with industry, not-for-profits and academic sponsors to provide a suite of trial and site management, and sponsor oversight services to local clinical research programs. These services include: training, trial monitoring, quality assurance, ethical and regulatory expertise; contract negotiation and trial coordination among others. Leveraging its indigenous knowledge of the clinical trial landscape in the region, it has developed a database of potential and current local investigators capable of conducting registration trials. The lessons learnt in each project are documented and shared with investigator staff at new sites.

Results

We conducted 23 monitoring visits at an academic site for a phase Ib HIV vaccine study and malaria phase IV drug trial monitoring visits in Kenya and Tanzania. Academic epidemiological tuberculosis studies were also conducted and we developed partnerships with professional development programs in industry and academia.

Conclusions

Africa is the next frontier for clinical research enterprise, and the need for developing local human resource capacity is critical. This will make the region attractive for industry sponsored trials for poverty-related diseases and other indications.
PERFORMANCE OF XPERT MTB/RIF AND DETERMINE LAM IN HIV-INFECTED ADULTS IN PERI-URBAN SITES IN ZAMBIA (CDC OP-X STUDY)
Authors: Kasaro Margaret Phiri , Muluka Brenda , Kaunda Kaunda , Morse Jill , Westfall Andrew , Kapata Nathan , Kruuner Annika , Henostroza German , Reid Stewart
Published: February 2017

Background

Tuberculosis (TB) mortality in HIV-infected patients remains high in sub-Saharan Africa. Inadequate diagnostic tools delay time to TB treatment.

Methods

A two-phase TB diagnostic study was conducted among HIV-infected adult patients from 2014–2016. Patients underwent history/physical exam, chest x-ray, urine for lipoarabinomannan (LAM), sputum smear and culture. We evaluated sensitivity, specificity and time to appropriate treatment within 14 and 28 days of screening for culture-positive patients, comparing Xpert MTB/RIF assay (GXP), and LAM to standard-of-care (SOC) in 3 peri-urban clinics. chi-square and Wilcoxon Rank-Sum tests were used to test for differences between SOC and GXP for categorical variables and continuous variables, respectively.

Results

1353 patients were enrolled; 755 in the SOC arm and 598 in the GXP arm. Median age was 34.3 and 65.1% were male. TB was diagnosed by any method (smear, clinical, GXP, LAM, culture) in 237 (17.5%) and with positive MTB culture in 152 (11.2%); 84 and 68 in the SOC and GXP arms, respectively. The overall sensitivity and specificity (culture as reference standard) of SOC was 91.7% and 92.9% respectively while GXP was 50.8% and 99.2%, respectively. LAM, when used with SOC, did not improve sensitivity or specificity in any CD4 strata, however when used with GXP increased sensitivity from 20% to 50% at CD4<50. There was a marginally significant difference (p=0.08) at 14-day TB treatment initiation between the GXP and SOC phases but no difference at 28-days. Among those initiating therapy, the median time to TB treatment initiation was shorter for the GXP arm (4vs15 days).

Conclusions

GXP did not significantly increase the number or accuracy of TB diagnoses compared to SOC but reduced median number of days to TB treatment by 11 days. GXP and LAM when used together have the potential to rapidly identify TB in patients with advanced HIV disease.
INTRODUCTION OF A NEW VACCINE INTO NATIONAL IMMUNISATION PROGRAMMES IN AFRICA: THE ROLE OF CAPACITY BUILDING
Authors: Dochez Carine , Burnett Rosemary , Mphahlele M. Jeffrey
Published: February 2017

Background

Members of National Immunisation Technical Advisory Groups, policy-makers, EPI managers and vaccinators are tasked with making evidence-based recommendations and decisions on whether a new vaccine merits introduction into national immunisation programmes; implementation of new vaccine introduction; and efficient management of immunisation programmes. Therefore it is paramount that they are equipped with the latest state-of-the-art information on vaccines and immunisation.

Methods

Capacity building activities – such as high-level in-service vaccinology courses, other interactive courses and workshops (mid-level management training and experience exchange workshops) – address all steps required for decision-making on new vaccine introduction into national immunisation programmes. These include establishing: 1) burden of disease to be prevented; 2) existence of a good intervention (i.e. is the vaccine efficacious, safe and acceptable for the target population); 3) the cost of the new vaccine, its implementation and the comparative effectiveness with other vaccines/interventions in terms of health gains; 4) whether finances to pay for the new vaccine are available; and 5) programmatic implications. Interested parties are trained on this rational decision-making process to be followed before embarking on new vaccine introduction, on key implementation steps, and efficient management of immunisation programmes.

Results

Several inter-country vaccinology courses and interactive workshops, which were organised during the last years in the African region (e.g. Kenya and South Africa), will be presented in detail. These capacity building activities have contributed to successful introduction of new vaccines in the African region, key ones being rotavirus, pneumococcal and currently human papillomavirus vaccines. This concerted effort has contributed for example to the successful introduction of rotavirus vaccine in 29 African countries to date.

Conclusions

Capacity building efforts, like high-level in-service courses and interactive workshops have enabled interested parties to make evidence-based recommendations and decisions on the introduction of any new vaccine, and to successfully implement new vaccine introduction.
DEVELOPING A GLOBAL CORE COMPETENCY FRAMEWORK FOR CLINICAL RESEARCH
Authors: Julé Amélie , Furtado Tamzin , Boggs Liam , Loggerenberg François Van , Lang Trudie
Published: February 2017

Background

Lack of recognition for working in clinical research is widely cited as an impediment to its conduct. There is a lack of career structure for the many roles involved (investigators, trial managers, nurses, etc.), and a lack of understanding of who does what. Competency frameworks exist for some individual job roles, but these are infrequent; thus the need for a global framework describing roles and responsibilities in a research team. This would facilitate appraisal of staff, promote career development by highlighting acquired skills, and illuminate areas where training opportunities are lacking.

Methods

In this project, we combine 28 frameworks created by external groups, with information from 116 job descriptions obtained from partners in clinical trial units worldwide, including input from the EDCTP Networks of Excellence, and from the web, to create a widely-encompassing framework derived from 11 different roles. Using qualitative analysis software, we systematically assess the activities performed by the clinical research team to categorise them and define underlying knowledge-, skill- or task-based competencies.

Results

The resulting framework counts 50 competencies required throughout the research life cycle, from assessment of scientific literature to results dissemination via project management, public engagement or grant application. It is applicable to studies that may differ in design, geographical location, disease, etc., and can be adapted to the particular needs of specific projects or roles. The framework was subject to an initial validation through consultations with over 30 global health research experts in collaboration with WHO-TDR in September 2015, resulting in enhancements and its subsequent beta release.

Conclusions

The adaptable ‘Global Core Competency Framework for Clinical Research’ is now accessible via The Global Health Network, alongside a protocol for individuals who may wish to pilot test it in their work. The framework may be further refined before being finally approved and launched in collaboration with WHO-TDR.
EVALUATION OF CIRCULATING CATHODIC ANTIGEN (CCA) URINE-CASSETTE ASSAY AS A SURVEY TOOL FORSCHISTOSOMA MANSONIIN DIFFERENT TRANSMISSION SETTINGS WITHIN BUGIRI DISTRICT, UGANDA
Authors: Adriko Moses
Published: February 2017

Background

Diagnosis of schistosomiasis at the point-of-care is a growing topic in neglected tropical disease research. There is a need for diagnostic tests which are affordable, sensitive, specific, user-friendly, rapid, equipment-free and delivered to those who need it, and point-of-care is an important tool for disease mapping and guiding mass deworming.

Methods

Our study was conducted among 500 school children randomly selected across 5 schools within Bugiri district, adjacent to Lake Victoria in Uganda. Duplicate Kato-Katz thick smears were prepared in the field upon receipt of the faecal samples and were read under a microscope within 60 minutes of slide preparation to determine hookworm status. The slides were again read 24 hours later forAscaris lumbricoides,Trichuris trichiuraandS. mansoniand this was repeated for all subsequent stool samples.

Results

Of the 469 pupils who provided three stool samples for the six Kato-Katz smears, 293 (76%) children had no infection, 109 (23%) were in the light intensity category, while 42 (9%) and 25 (5%) were in the moderate and heavy intensity categories, respectively. Following performance analysis of CCA tests in terms of sensitivity, specificity, negative and positive predictive values, the overall performance of the commercially available CCA test was more informative than single Kato-Katz faecal smear microscopy, the current operational field standard for disease mapping.

Conclusions

The current CCA assay is a satisfactory method for surveillance ofS. mansoniin an area where disease endemicity is declining due to control interventions. The urine point-of-care CCA test is an attractive tool to augment and perhaps replace the Kato-Katz sampling within ongoing control programmes.
COMMUNITY KNOWLEDGE, ATTITUDES AND PRACTICES (KAP) DURING MDA INTEGRATED MALARIA ELIMINATION AND SCHISTOSOMIASIS AND SOIL-TRANSMITTED HELMINTHS CONTROL STUDY IN NGODHE ISLAND, LAKE VICTORIA, KENYA
Authors: Mwaura Peter , Kongere James , Omolloh Kevin , Gitaka Jesse
Published: February 2017

Background

Knowledge, attitudes and practices (KAP) of communities where mass drug administration based integrated malaria elimination and control of schistosomiasis and soil transmitted helminths (STH) is targeted will be critical in adhering to intervention strategies. KAP surveys have the potential to reveal lessons that will inform implementation in similar settings. This study sought to assess knowledge, attitudes and practices of Ngodhe islanders in Lake Victoria Kenya during mass drug administration (MDA) with artemisinin-piperaquine and low dose primaquine for malaria; albendazole for STH and praziquantel for schistosomiasis.

Methods

The KAP study used a pre-tested interviewer questionnaire that was administered to 239 randomly selected adults. Additionally, 4 focus group discussions (each consisting of between 8–12 participants) was done with the elders, women, youth, and mixed group. Another 6 key informant interviews were also done.

Results

All respondents (239) had heard about malaria and they acknowledged that it is preventable; 89.1% of respondents had heard about schistosomiasis; and another 87.4% had heard about STH. A high percentage of 96.2 had heard about the mass drug administration while 87% were aware of the integrated malaria, schistosomiasis, and STH strategy. 78.2% of participants favoured stopping MDA in case side effects were perceived to be common. Sanitation was a major challenge with only 41.3% of the respondents using latrines with the rest using bushes.

Conclusions

This study revealed huge awareness of the integrated strategy for malaria elimination and schistosomiasis and STH control using mass drug administration. Nonetheless, concerns on MDA drugs side effects and poor sanitation practices will require greater engagement with the community.
INTERRUPTED BANCROFTIAN FILARIASIS EXPOSURE RATES IN CHILDREN AFTER TWELVE ROUNDS OF MASS DRUG ADMINISTRATION AND USE OF LONG-LASTING INSECTICIDAL NETS IN RUFIJI DISTRICT, TANZANIA
Authors: Jones Clarer , Ngasala Billy , Malecela Mwelecele
Published: February 2017

Background

Tanzania started implementing the WHO strategy of mass drug administration (MDA) with ivermectin and albendazole to eliminate lymphatic filariasis (LF) in Rufiji District, which had a baseline prevalence of 49% in 2000. This study was conducted in April 2015, six months after the latest MDA to establish the impact of MDA and utilisation of long-lasting insecticidal nets on the exposure rates of LF among standard-one children born within the implementation period of the LF elimination programme after 12 rounds.

Methods

A cross-sectional study for LF circulating filarial antigen (CFA) was performed in 5 primary schools from 5 different villages. A total of 659 standard-one pupils aged 6–9 years were recruited and screened for CFA using immunochromatographic test cards (ICT). Prior to blood sample collection, children were interviewed on their participation in the MDA. A finger prick whole blood sample (100 µl) drawn from each child was applied to ICT. Results were read after ten minutes for the presence of CFA. Also, the study involved 868 heads of household who were interviewed on their participation in MDA and utilisation of long-lasting insecticidal nets (LLINs).

Results

The ICT results were negative for CFA and suggest that there has been an interruption of exposure of children to LF transmission in the study area. More than half of the screened children (54.3%) participated in 2014 MDA round. Household surveyed MDA coverage was 57.4% for the 2014 MDA, below the minimum effective coverage recommended by WHO. Majority (92.5%) of households possessed and utilised LLINs. Of those who did not take the drugs in the last round, 88.7% possessed and utilised LLINs suggesting its synergistic effect with ivermectin and albendazole on LF transmission.

Conclusions

Additional MDA rounds and utilisation of LLINs in areas of high-baseline prevalence may result in considerable decreased lymphatic filariasis infection transmission.
MODIFIABLE RISK FACTORS OF BURULI ULCER IN COMMUNITIES OF TWO ENDEMIC LOCAL GOVERNMENT AREAS OF OGUN STATE, NIGERIA
Authors: Akinwale Olaoluwa , Adeneye Adeniyi , Ezeugwu Sylvanus , Olukosi Yetunde , Adewale Babatunde , Sulyman Medinat , Mafe Margaret , Okwuzu Jane , Gyang Pam , Nwafor Timothy , Henry Uzoma , Musa Bilkisu , Ujah Innocent
Published: February 2017

Background

Buruli ulcer (BU) remains a neglected tropical disease globally including in Nigeria despite its severe health and socio-economic consequences. This study was conducted as there is a paucity of data on community knowledge and risk factors of BU in Nigeria.

Methods

The study was conducted in the BU-endemic Yewa North and Yewa South local government areas (LGAs) of Ogun State, Nigeria. Study population included community members selected using multi-stage sampling techniques. Household survey using a semi-structured questionnaire was used for data collection. Data were analysed using SPSS (version 20) software.

Results

A total of 236 consented respondents were interviewed (Yewa North 76.7%vsYewa South 23.3%; males 48.7%vsfemales 51.3%) with an average age of 33.1 years. Only 39.0% had a minimum of secondary education. A little over half (128; 54.2%) reported having knowledge of BU in their communities. However, only 35.6% adjudged BU a common disease in their communities while 56.0% perceived it as a serious health challenge. Few (14.0%) respondents had an average of one household member who had or have BU. Most (64.8%) did not know the cause of BU while 9.7% attributed it to witchcraft/Olobutu, bacteria (4.2%), water contact (3.0%) and poor hygiene (3.0%). 53.4% visit riverbanks for activities that were predominantly: washing (37.3%); swimming (35.7%); fetching water (19.8%); and agricultural activities (4.0%). Gender and age had no significant influence on respondents' knowledge of the cause of BU (p>0.05). Swimming and other activities on the riverbanks associated with BU had significant correlation with report of BU cases in the household (p< 0.05).

Conclusions

Pervasive knowledge of BU cases and high-perceived seriousness of the disease in the study communities exist. Nonetheless, there is need for more public health education emphasising common modifiable risk factors and actual cause of BU. Overall, these results provide insights for BU programme planning and optimisation.
IS TRACHOMA ON TRACK FOR ELIMINATION BY 2020? MONITORING AND SURVEILLANCE AFTER MASS DRUG ADMINISTRATION WITH AZITHROMYCIN FOR ACTIVE TRACHOMA IN GUINEA BISSAU
Authors: Cowley Giovanna , Silva Eunice Teixeira Da , Nabicassa Meno , Barros Pedrozinho Duarte Pereira De , Blif Milena Mbote , Bailey Robin , Last Anna
Published: February 2017

Background

Guinea Bissau is a trachoma-endemic country that has pledged to eliminate blinding trachoma by 2020 by implementation of the SAFE strategy. Evidence for elimination is to be presented in a dossier to WHO. Mass drug administration (MDA) with azithromycin for active trachoma has been carried out in the Bijagos and Cacheu regions. Through collaboration with government and non-government agencies, we conducted coverage and impact surveys to evaluate success of MDA and build capacity in monitoring and surveillance activities within the Programa Nacional de Saude de Bissau. Our surveys demonstrate the feasibility of compiling the elimination dossier and show promising results.

Methods

(1) Coverage survey (Bijagos): Seven households were randomly selected from 17 villages on five islands which had received MDA 1 month previously. Household members reported whether they had taken azithromycin and population coverage was calculated. (2) Impact survey (Cacheu): 15 households were randomly selected from 20 clusters. Trained ophthalmic nurses recorded cases of follicular trachoma (TF) amongst 1–9 year-olds and of trachomatous trichiasis (TT) amongst people aged 15 and above. Prevalence estimates of TF and TT were calculated.

Results

(1) MDA Coverage (Bijagos): Estimated MDA coverage was 90.9% overall (n=518) and 94.4% amongst children aged 1–9. (2) Impact survey (Cacheu): 701 1–9 year-olds and 1557 >14 year-olds were examined. The estimated prevalence of TF1–9 was 0.3% and that of unoperated TT>14 was between 0.1 and 0.4%.

Conclusions

These surveys provide evidence that MDA can achieve very high levels of coverage in remote and poorly accessible areas and can reduce TF to below the WHO elimination threshold. Successful TF elimination can allow focus to shift to operating TT, which remains a significant public health problem after MDA. These surveys demonstrate how sound epidemiological methods can be used in programmatic settings to evaluate elimination campaigns, guide future programme activities and contribute to global data collection.
ESTABLISHMENT OF A SUB-REGIONAL ETHICS COMMITTEE IN CENTRAL AFRICA TO ADDRESS THE NEEDS OF MULTICOUNTRY PROJECTS: AN OCEAC INITIATIVE
Authors: Nona Sylvie Kwedi
Published: February 2017

Background

The Universal Declaration on Bioethics and Human Rights, adopted by UNESCO, requires that governments establish National Ethics Committees (NECs) capable of reviewing ethical and scientific aspects on research involving human beings. These NECs are government gatekeepers tasked with ensuring that research conducted in their territories is in compliance with national and international ethics requirements. In Central Africa, NECs are lacking in some countries, barely functional in others either crippled by lack of expertise, scarce opportunities for training or by an environment not conducive to quality and ethical research. To remedy this shortcoming, OCEAC was awarded an EDCTP grant to put in place a common Ethics Committee for Central Africa.

Methods

Six designated representatives of Ministries of Health, with appropriate background and skills, from Cameroon, Chad, Equatorial Guinea, Gabon, Republic of Congo, and the Central African Republic were selected to be members of the sub-regional Ethics Commitee. In order to ensure the proper composition of this committee, ethics experts originating from central Africa were selected through a call for candidates widely published in various ethics and research networks in the sub-region.

Results

CERSAC (Comité d'Ethique de la Recherche et de la Santé en Afrique Centrale) is the designation of the resulting sub-regional Ethics Committee, assembling fifteen members from the six CEMAC countries and the Democratic Republic of Congo. Since 2014, CERSAC has provided streamlined reviews of health research projects conducted in more than one Central Africa country. A total of 37 local emerging-career researchers and ethics committee members were trained.

Conclusions

CERSAC enhances the ethical conduct and social value of research and optimises the protection of human research participants for communities in dire need. The committee also provides a harmonised platform to address ethical challenges related to the conduct and output of health research in Central Africa.
INVOLVEMENT OF STAKEHOLDERS IN THE REPORTING PROCESS OF SERIOUS ADVERSE EVENTS DURING CLINICAL TRIALS IN A SUB-SAHARAN RESEARCH CENTER, LAMBARÉNÉ, GABON
Authors: Lumeka Kabwende , Todagbe Agnandji
Published: February 2017

Background

The pharmacovigilance of medical products for human use should start during the clinical development and continues after licensure. In developed countries, regulatory agencies are actively involved in all steps of pharmacovigilance. In sub-Saharan African countries, the lack and weaknesses of national regulatory authorities are being addressed through regional regulatory authorities like AVAREF 2 which aims to oversee pharmacovigilance duties across countries. Informing such initiative about the current practices for the reporting of serious adverse events is needed.

Methods

We reviewed the reporting of clinical trials performed in CERMEL from 2006–2016. The methods of serious adverse events (SAE) reporting and handling was the main objective of the review.

Results

The most frequent methods used to reporting SAE for the clinical trials reviewed in Lambarene were: 31% (5/16) paper Case Report Forms (CRF) only, 25% (4/16) electronic case report form (eCRF) without alert, 13% ( 2/16) paper CRF+phone call and 13% (2/16) phone +email or fax+ paper CRF and 6% (1/16) electronic SAE reporting system with alert. Generally, all studies reported SAEs directly to the sponsors who reacted according to their guidelines. Only 2 of 16 studies could involve the Institutional Review Board (IRB), Ethics Committees, and the Data Safety Monitoring Committee (DSMC) and eventually reported to the Regulatory Authorities in the country. The Local Safety Monitoring was involved only in one study which used the eCRF with alert.

Conclusions

It appears that in the current practices, the reporting and handling of SAEs are mainly done by investigators and sponsors. Although both are the key stakeholders to do so, more active involvement of regulatory authorities is an essential step towards establishment of a pharmacovigilance system and would improve the community engagement towards clinical trials. Electronic reporting with alert system could be one of the methods suitable to involve all partners.