bluuebunny/crossref_metadata_2025_split huggingface dataset:
A REVIEW OF REGULATORY CAPACITY STRENGTHENING IN AFRICA IN HIV RESEARCH: THE NEED FOR A NEW PARADIGM
Authors: Fisher Kevin , Bahati Prince , Thyagarajan Bargavi 
Published: February 2017

BackgroundRecent African initiatives suggest the need for new direction in capacity building and support for regulatory review of HIV prevention research. The African Vaccine Regulatory Forum recently harmonised practices to strengthen regulatory oversight and helped create the African Medicines Agency scheduled to be launched in 2018. The African Union, working through the New Partnership for Africa's Development, took a major step in 2016 adopting the African Union Model Law on Medical Product Regulation. These steps, as well as the work of the African Medicines Regulatory Harmonisation Programme, raise the question of how best to effect regulatory capacity building in this new environment.MethodsThis paper assesses the evolving role of support for African regulatory systems using a desk review of various regulatory strengthening activities currently underway or planned, with focus on Africa. This review was supplemented by interviews with key informants related to activities intended to support regulatory capacity building in low- and middle-income countries focused upon efforts that were of potential assistance to HIV vaccine development. This analysis supplements findings from a Regulatory Capacity Building Workshop held in Rwanda in 2015.ResultsExternal capacity building efforts need to be responsive to new and/or recent priorities and mechanisms by African entities regarding the strengthening and coordination of regulatory systems. Current capacity building efforts will benefit from coordination and information sharing geared toward new initiatives, as well as focus around ethics review.ConclusionsRemarkable progress is being made towards the development of a safe and effective HIV prevention options, and several HIV vaccine efficacy trials are planned over the next few years. Recent ambitious African regulatory initiatives hold the potential to expedite review. It is time for capacity building efforts to consider how best to support the new coordinated and regional regulatory systems being developed and launched over the next few years.
PREVALENCE OF HBV, HIV, AND HIV-HBV CO-INFECTIONS AMONG HEALTHCARE WORKERS IN IBADAN, NIGERIA
Authors: Opaleye Oluyinka , Akanbi Olusola , Binuyo Michael 
Published: February 2017

BackgroundHIV and HBV are endemic in Nigeria. HBV is globally the leading cause of death due to liver disease amongst HIV-infected persons. The study was done to ascertain the prevalence rate of HIV, HBV and HIV-HBV co-infections amongst health care workers in Ibadan, Nigeria.MethodsA total of 217 healthcare workers working in large hospitals in Ibadan, Nigeria were signed up for the study. The socio-demographical data of the health care workers were collected using a questionnaire. HIV antibodies were evaluated using Stat Pak HIV test strips and HBV was evaluated using the ABON HBsAg test strips.ResultsThere were 85 (39.2%) male and 132 (60.8%) female health care workers. Most were 21–35 years of age (109/217, 50.2%). Of the 217 health care workers 103(47.5%) and 21(9.7%) were positive for HBsAg and HIV, respectively, while 3(1.4%) had HIV-HBV co-infections. The prevalence of HBV infection was statistically significant (p<0.005) over HIV infection. Health care workers with ‘other’ level of education had the most predominant HBV prevalence (58/83, 69.9%, p=0.0267) while those with primary level of education had the highest HIV prevalence (2/12, 16.7%, p=0.0267. Females had the most predominant HBV (72/132, 54.5%) and HIV (17/132, 12.9%) (p=0.03). HIV was highest in age groups<20 years (2/16, 12.5%). Only widows/widowers (33.3%) had the highest HIV-HBV co-infection rates. Presence of tattoo in any part of the body, hepatitis B vaccination was significantly associated (p< 0.05) with HBV seropositivity among health care workers.ConclusionsThis study reveals a high prevalence of HIV, HBV and HIV-HBV co-infections among female health care workers. From our finding, the high infection rates of HBV and HIV noted amongst health care workers indicate the need to regularly screen this group for these viruses to reduce the further transmission of these viral infections.
DO XPERT MTB/RIF CYCLE THRESHOLD VALUES PROVIDE INFORMATION ABOUT PATIENT DELAYS FOR TUBERCULOSIS DIAGNOSIS?
Authors: Ssengooba Willy , Respeito Durval , Mambuque Edson , Blanco Silvia , Mandomando Inacio , Jong Bouke De , Cobelens Frank , Garcia-Basteiro Alberto 
Published: February 2017

BackgroundEarly diagnosis and initiation to appropriate treatment is vital for tuberculosis (TB) control. The Xpert MTB/RIF (Xpert) assay offers rapid TB diagnosis and quantitative estimation of bacterial burden through Cycle threshold (Ct) values. We assessed whether the Xpert Ct value is associated with delayed TB diagnosis as a potential monitoring tool for TB control programme performance.MethodsThis analysis was nested in a prospective study under the routine TB surveillance procedures of the National TB Control Program in Manhiça district, Maputo province, Mozambique. Presumptive TB patients were tested using smear microscopy and Xpert. We explored the association between Xpert Ct values and self-reported delay of Xpert-positive TB patients as recorded at the time of diagnosis enrolment. Patients with >60 days of TB symptoms were considered to have long delays.ResultsOf 1483 TB presumptive cases, 580 were diagnosed as TB of whom 505 (87.0%) were due to pulmonary TB and 302 (94.1%) were Xpert positive. Ct values (range, 9.7–46.4) showed a multimodal distribution. The median (IQR) delay was 30 (30–45) days. Ct values showed no correlation with delay (R2=0.001, p=0.621), nor any association with long delays: adjusted odds ratios (AOR) (95% CI) comparing to >28 cycles 0.99 (0.50–1.96; p=0.987) for 23–28 cycles, 0.93 (0.50–1.74; p=0.828) for 16–22 cycles; and 1.05 (0.47–2.36; p=0.897) for <16 cycles. Being HIV-negative (AOR [95% CI]), 2.05 (1.19–3.51, p=0.009) and rural residence 1.74 (1.08–2.81, p=0.023), were independent predictors of long delays.ConclusionsXpert Ct values were not associated with patient delay for TB diagnosis and cannot be used as an indicator of TB control program performance.
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

BackgroundDespite 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.MethodsIn-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.ResultsHealth 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.ConclusionsFindings 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

BackgroundHepatitis 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.MethodsThe 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).ResultsTo 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%).ConclusionsHalf 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

BackgroundEarly 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.MethodsA 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.ResultsA 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.ConclusionsPoint-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

BackgroundMaternal 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.MethodsBetween 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).ResultsIn 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.ConclusionsDespite 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

BackgroundCommunicating 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.MethodsAdults 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.ResultsOn 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.ConclusionsA 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

BackgroundPrevention 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.MethodsAs 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).ResultsDuring 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.ConclusionsOur 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

BackgroundEnteric 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.MethodsS. 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.ResultsA 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.ConclusionsThe 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.