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Abstract Background Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis. Methods The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups. Discussion The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies. Trial registration Current Controlled Trials ISRCTN15334496

Objectives: This work aimed to describe the nutritional status of French older adults (age ≥ 90 years) and studied the association between oral health and nutritional status., Methods: A cross-sectional study was carried out in 2014 among the participants of a cohort on cerebral and functional aging in France at their 25-year follow up (the PAQUID cohort). Nutritional status (Mini Nutritional Assessment [MNA]) and oral health status (number of decayed, missing, and filled teeth [DMFT], number of posterior occluding pairs, xerostomia [Xerostomia Inventory], and prosthetic rehabilitation) were recorded at the participants' living places by two dentists. Univariate and multivariate logistic regressions were used to explore the association between oral health and nutritional status, with adjustments for potential confounders. Odds ratios (OR) were estimated with their 95% confidence interval (CI)., Results: 87 participants were included in the analyses: 74.7% were females and the mean age was 94.1 years (± 3.0). Malnutrition or risk of malnutrition (MNA < 24) was present in 23 participants (26.4%), with only one having malnutrition. The mean DMFT score was 26.5 (± 5.3). The mean number of posterior occluding pairs was 1.5 (± 2.3). Twenty-one participants had xerostomia (24.1%). Only 8.1% of the participants had all their teeth or adequate dentures; 47.1% had inadequate dentures, while 44.8% had no dentures despite tooth loss. After adjustment, xerostomia (OR = 8.79; 95% CI = 2.38-39.10; p = 0.002) was found to be associated with malnutrition or risk of malnutrition., Conclusion: Being at risk of malnutrition was common among people ≥ 90 years old and was associated with xerostomia. NCT04065828., (© 2022. The Author(s).)

Background: Adolescents living with perinatally-acquired HIV (APHIV) face challenges including HIV serostatus disclosure. We assessed their 24-month outcomes in relation to the disclosure of their own HIV serostatus. Methods: Nested within the International epidemiologic Database to Evaluate AIDS pediatric West African prospective cohort (IeDEA pWADA), the COHADO cohort included antiretroviral (ART)-treated APHIV aged 10-19 years, enrolled in HIV care before the age of 10 years, in Abidjan (Côte d'Ivoire) and Lomé (Togo) in 2015. We measured the HIV serostatus disclosure at baseline and after 24 months and analyzed its association with a favorable combined 24-month outcome using logistic regression. The 24-month combined clinical immuno-virological outcome was defined as unfavorable when either death, loss to follow-up, progression to WHO-AIDS stage, a decrease of CD4 count >10% compared to baseline, or a detectable viral load (VL > 50 copies/mL) occurred at 24 months. Results: Overall, 209 APHIV were included (51.6% = Abidjan, 54.5% = females). At inclusion, the median CD4 cell count was 521/mm 3 [IQR (281-757)]; 29.6% had a VL measurement, of whom, 3.2% were virologically suppressed. APHIV were younger in Lomé {median age: 12 years [interquartile range (IQR): 11-15]} compared to Abidjan [14 years (IQR: 12-15, p = 0.01)]. Full HIV-disclosure increased from 41.6% at inclusion to 74.1% after 24 months. After 24 months of follow-up, six (2.9%) died, eight (3.8%) were lost to follow-up, and four (1.9%) were transferred out. Overall, 73.7% did not progress to the WHO-AIDS stage, and 62.7% had a CD4 count above (±10%) of the baseline value (48.6% in Abidjan vs. 69.0% in Lomé, p < 0.001). Among the 83.7% with VL measurement, 48.8% were virologically suppressed (Abidjan: 45.4%, Lomé: 52.5%, p <0.01). The 24-month combined outcome was favorable for 45% (29.6% in Abidjan and 61.4% in Lomé, p < 0.01). Adjusted for baseline variables, the 24-month outcome was worse in Lomé in those who had been disclosed for >2 years compared to those who had not been disclosed to [aOR = 0.21, 95% CI (0.05-0.84), p = 0.03]. Conclusions: The frequency of HIV-disclosure improved over time and differed across countries but remained low among West African APHIV. Overall, the 24-month outcomes were poor. Disclosure before the study was a marker of a poor 24-month outcome in Lomé. Context-specific responses are urgently needed to improve adolescent care and reach the UNAIDS 90% target of virological success., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Dassi Tchoupa Revegue, Takassi, Tanoh Eboua, Desmonde, Amoussou-Bouah, Bakai, Jesson, Dahourou, Malateste, Aka-Dago-Akribi, Raynaud, Arrivé and Leroy.)

Objectives: To assess the effect of periodontal treatment on clinical and biochemical parameters of rheumatoid arthritis (RA) and quality of life (QoL) in patients with moderately active RA who were diagnosed with periodontitis., Methods: In this open-label randomised controlled trial, RA subjects (n = 22) were allocated to "immediate" or "delayed" periodontal treatment (full-mouth non-surgical scaling and root planing, systemic antibiotics, and oral hygiene instructions). The main outcome was the 3-month change on the Disease Activity Score 28 based on the Erythrocyte Sedimentation Rate (DAS28-ESR). The Health Assessment Questionnaire and the General Oral Health Assessment Index were used to assess general and oral health QoL, respectively., Results: Periodontal health significantly improved after periodontal treatment (P = 0.03). Periodontal treatment appeared to be safe but led to no significant effects on the DAS28-ESR (adjusted mean difference with 95% confidence interval (aMD) of -0.03 [-0.98; 0.92]). There was no evidence of improvement in the general QoL after periodontal treatment and no significant effect was found for the oral health QoL, despite a positive trend in the "psychological impacts" domain (aMD of 0.13 [-0.07; 0.33], P = 0.20)., Conclusions: Although no clinical effect of periodontal treatment on RA was identified, this trial provides important data to support periodontal care in RA patients. Periodontal treatment is safe and reduces oral inflammation with a possible effect on oral health QoL. Since both periodontitis and RA are complex and multifactorial chronic diseases, it is likely that patient-centred approaches involving both oral health professionals and rheumatologists will contribute to optimal patient care. ISRCTN79186420., (Copyright © 2019 Société française de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.)

Aim: To assess whether periodontal treatment can lead to clinical, glycaemic control and quality of life improvements in metabolically unbalanced diabetic patients (type 1 or type 2) diagnosed with periodontitis., Methods: In this open-labelled randomized controlled trial, diabetic subjects (n = 91) were given "immediate" or "delayed" periodontal treatment (full-mouth non-surgical scaling and root planing, systemic antibiotics, and oral health instructions). The main outcome was the effect on glycated haemoglobin (HbA 1C ) and fructosamine levels. The General Oral Health Assessment Index and the SF-36 index were used to assess quality of life (QoL)., Results: Periodontal health significantly improved after periodontal treatment (p < 0.001). Periodontal treatment seemed to be safe but had no significant effects on glycaemic control based on HbA 1C (adjusted mean difference with a 95% confidence interval (aMD) of 0.04 [-0.16;0.24]) and fructosamine levels (aMD 5.0 [-10.2;20.2]). There was no obvious evidence of improvement in general QoL after periodontal treatment. However, there was significant improvement in oral health-related QoL (aMD 7.0 [2.4;11.6], p = 0.003)., Conclusion: Although periodontal treatment showed no clinical effect on glycaemic control in this trial, important data were provided to support periodontal care among diabetic patients. Periodontal treatment is safe and improves oral health-related QoL in patients living with diabetes. ISRCTN15334496., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Introduction: Disclosure of HIV status to HIV-infected children and adolescents is a major care challenge. We describe current site characteristics related to disclosure of HIV status in resource-limited paediatric HIV care settings within the International Epidemiology Databases to Evaluate AIDS (IeDEA) consortium., Methods: An online site assessment survey was conducted across the paediatric HIV care sites within six global regions of IeDEA. A standardized questionnaire was administered to the sites through the REDCap platform., Results: From June 2014 to March 2015, all 180 sites of the IeDEA consortium in 31 countries completed the online survey: 57% were urban, 43% were health centres and 86% were integrated clinics (serving both adults and children). Almost all the sites (98%) reported offering disclosure counselling services. Disclosure counselling was most often provided by counsellors (87% of sites), but also by nurses (77%), physicians (74%), social workers (68%), or other clinicians (65%). It was offered to both caregivers and children in 92% of 177 sites with disclosure counselling. Disclosure resources and procedures varied across geographical regions. Most sites in each region reported performing staff members' training on disclosure (72% to 96% of sites per region), routinely collecting HIV disclosure status (50% to 91%) and involving caregivers in the disclosure process (71% to 100%). A disclosure protocol was available in 14% to 71% of sites. Among the 143 sites (79%) routinely collecting disclosure status process, the main collection method was by asking the caregiver or child (85%) about the child's knowledge of his/her HIV status. Frequency of disclosure status assessment was every three months in 63% of the sites, and 71% stored disclosure status data electronically., Conclusion: The majority of the sites reported offering disclosure counselling services, but educational and social support resources and capacities for data collection varied across regions. Paediatric HIV care sites worldwide still need specific staff members' training on disclosure, development and implementation of guidelines for HIV disclosure, and standardized data collection on this key issue to ensure the long-term health and wellbeing of HIV-infected youth., (© 2018 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.)

Background: Poor oral health has been associated with some components of frailty. The objective of this study was to identify the association between clinical measures of oral health and the incidence of frailty among community-dwelling older adults aged 70 or older in Mexico City., Methods: A 3-year cohort study with a probabilistic representative sample of home-dwelling elders of one district of Mexico City was performed. Baseline and follow-up interview and oral clinical evaluations were carried out by standardized examiners in participants' homes. Dependent variable was incident frailty defined according to the frailty phenotype. Independent variables were the utilization of dental services, the presence of xerostomia, the number of natural teeth, use of removable dental prostheses, presence of severe periodontitis, and presence of root remnants. Sociodemographic, behavioral, and health measures were included as confounders. The association between oral health conditions and incident frailty was modeled using Poisson regression models with robust variance estimators. The models were adjusted for confounders and interactions., Results: We identified a 14.8% cumulative incidence of frailty. Each additional tooth was associated with a lower probability of developing frailty by 5.0% (risk ratio = 0.90; 95% CI 1.02-1.10). The 3-year risk ratio of developing frailty was 2.13 times higher (95% CI 1.01-4.50) among participants having severe periodontitis., Conclusions: The number of teeth and the presence of severe periodontitis are associated with the development of frailty after controlling for confounders. Further studies are needed on this topic., (© The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: The objectives of this study were to investigate the association between HIV infection and dental caries among children in West Africa, and to identify factors associated with dental caries among HIV-infected children., Methods: We conducted a multi-center cross-sectional study in Mali, Senegal and Côte d'Ivoire with a random sample of HIV-infected children aged 5-15 years on antiretroviral therapy and their uninfected siblings. A standardized examination was performed by calibrated dentists. The association between the number of decayed, missing or filled permanent and primary teeth surfaces (DMFdefS) and HIV status was investigated by fitting multivariable zero-inflated negative binomial models, for each age group (<12 and ≥12 years). Factors associated with dental caries could be investigated only for HIV-infected children <12 years old., Results: The sample included 420 HIV-infected children and 418 non-infected siblings. The median DMFdefS was 7 for the HIV-infected children and 2 for the uninfected siblings. The proportion of children with DMFdefS ≥1 was significantly higher among the HIV-infected children than uninfected children (86.0 percent versus 64.4 percent, P < 0.001). The HIV-infected children were less likely to be caries-free than the uninfected siblings in both age groups. We found a higher degree of caries experience among HIV-infected children < 12 years old, in whom it was associated with sweet drink consumption, history of night bottle use, immunosuppression, and younger age at study entry., Conclusions: Although preventable, the burden of dental disease was high in children from families affected by HIV in West Africa and was associated with HIV infection and immunosuppression., (© 2017 American Association of Public Health Dentistry.)

Background: Irreversible pulpitis is a highly painful inflammatory condition of the dental pulp which represents a common dental emergency. Recommended care is partial endodontic treatment. The dental literature reports major difficulties in achieving adequate analgesia to perform this emergency treatment, especially in the case of mandibular molars. In current practice, short-course, orally administered corticotherapy is used for the management of oral pain of inflammatory origin. The efficacy of intraosseous local steroid injections for irreversible pulpitis in mandibular molars has already been demonstrated but resulted in local comorbidities. Oral administration of short-course prednisolone is simple and safe but its efficacy to manage pain caused by irreversible pulpitis has not yet been demonstrated. This trial aims to evaluate the noninferiority of short-course, orally administered corticotherapy versus partial endodontic treatment for the emergency care of irreversible pulpitis in mandibular molars., Methods/design: This study is a noninferiority, open-label, randomized controlled clinical trial conducted at the Bordeaux University Hospital. One hundred and twenty subjects will be randomized in two 1:1 parallel arms: the intervention arm will receive one oral dose of prednisolone (1 mg/kg) during the emergency visit, followed by one morning dose each day for 3 days and the reference arm will receive partial endodontic treatment. Both groups will receive planned complete endodontic treatment 72 h after enrollment. The primary outcome is the proportion of patients with pain intensity below 5 on a Numeric Scale 24 h after the emergency visit. Secondary outcomes include comfort during care, the number of injected anesthetic cartridges when performing complete endodontic treatment, the number of antalgic drugs and the number of patients coming back for consultation after 72 h., Discussion: This randomized trial will assess the ability of short-term corticotherapy to reduce pain in irreversible pulpitis as a simple and rapid alternative to partial endodontic treatment and to enable planning of endodontic treatment in optimal analgesic conditions., Trial Registration: ClinicalTrials.gov, identifier: NCT02629042 . Registered on 7 December 2015. (Version n°1.1 28 July 2015).

Background: Worldwide, female sex workers (FSW) represent a vulnerable population for oral diseases due to many risk factors including HIV infection and drug abuse. In sub-Saharan Africa, little is known about the burden of oral diseases and their determinants in vulnerable populations. The aim of the study was to estimate the prevalence and associated factors of oral diseases among FSW., Methods: A cross sectional study was conducted among FSW who attended a dedicated non-profit clinic in Abidjan, Côte d'Ivoire from June to August 2013. Data about the presence of dental caries, periodontitis and oral-mucosal lesions were collected by a dentist during an oral examination. Behavioural information related to oral hygiene habits as well as tobacco and alcohol consumption were collected through a standardized questionnaire. Information related to HIV infection including HIV diagnosis, last known CD4 count and antiretroviral therapy were documented through a medical chart review. Logistic regression models were used to identify factors associated with oral diseases., Results: A total of 249 FSW with a median age of 29 years, [Inter Quartile Range (IQR) = 23-36] and a median duration of sex work of 24 months [IQR 9-60]) were included. Current tobacco use and hazardous alcohol use were reported in 21.7 % and 19.7 % of FSW, respectively. The estimated prevalence of HIV infection was 33.7 % [95 % confidence interval (CI); 27.8 - 39.6]) and 82.1 % of HIV-infected FSW were on antiretroviral therapy . The prevalence of dental caries, periodontitis and oral-mucosal lesions were 62.3 % [95 % CI 55.5 - 67.5], 14.5 % [95 % CI 10.2 - 18.9] and 8.2 % [95 % CI 4.8 - 11.5], respectively. In multivariate analysis, periodontitis, oral-mucosal lesions and HIV infection were associated with odds ratio of 2.6 [95 % CI, 1.2-5.8]) and 50.0 [95 % CI; 6.4-384.6]., Conclusions: This study showed a high prevalence of oral diseases among FSW in Abidjan. HIV infection was common and significantly associated with periodontal diseases and oral-mucosal lesions. There is a need to integrate regular screening and treatment of oral lesions into the medical follow-up of FSW along with strategies for HIV prevention.

Aims: The aims were to describe emtricitabine (FTC) pharmacokinetics in a large population of pregnant women during the different trimesters of pregnancy, and to explain FTC pharmacokinetic variability during pregnancy., Methods: FTC plasma concentrations were measured in 103 non-pregnant and 83 pregnant women, including women in the different trimesters of pregnancy and on the day of delivery. A total of 457 plasma concentrations were available for analysis. A population pharmacokinetic model was developed with Monolix 4.1.3., Results: FTC pharmacokinetics was best described by a two compartment model. The effect of creatinine clearance on apparent elimination clearance (CL/F) was significant. CL/F in pregnant women was significantly higher compared with non-pregnant women (geometric mean 24.1 vs 20.5 l h(-1) , P < 0.001), reflecting a modified renal function. FTC daily exposures (AUC) during pregnancy were lower than AUC in non-pregnant women, regardless of the trimester of pregnancy. FTC AUC geometric means were 8.38 mg l(-1 ) h in the second trimester of pregnancy, 8.16 mg l(-1 ) h in the third trimester of pregnancy, 8.30 mg l(-1 ) h on the day of delivery and 9.77 mg l(-1 ) h in non-pregnant women. FTC concentrations 24 h after administration were lower in pregnant women compared with non-pregnant women (0.054 vs. 0.079 mg l(-1) , P < 0.001) but still above the inhibitory concentration 50%., Conclusions: FTC CL/F was increased by 18% during pregnancy, reflecting a modified renal function with 50% increase in estimated glomerular filtration rate. However, the impact of this modified renal function on FTC pharmacokinetics was not sufficiently large to consider dose adjustments during pregnancy., (© 2014 The British Pharmacological Society.)

Objective: To estimate the prevalence of oral mucosal diseases and dental caries among HIV-infected children receiving antiretroviral treatment (ART) in West Africa and to identify the factors associated with the prevalence of oral mucosal lesions., Methods: Multicentre cross-sectional survey in five paediatric HIV clinics in Côte d'Ivoire, Mali and Sénégal. A standardised examination was performed by trained dentists on a random sample of HIV-infected children aged 5-15 years receiving ART. The prevalence of oral and dental lesions and mean number of decayed, missing/extracted and filled teeth (DMFdefT) in temporary and permanent dentition were estimated with their 95% confidence interval (95% CI). We used logistic regression to explore the association between children's characteristics and the prevalence of oral mucosal lesions, expressed as prevalence odds ratio (POR)., Results: The median age of the 420 children (47% females) enrolled was 10.4 years [interquartile range (IQR) = 8.3-12.6]. The median duration on ART was 4.6 years (IQR = 2.6-6.2); 84 (20.0%) had CD4 count<350 cells/mm(3). A total of 35 children (8.3%; 95% CI: 6.1-11.1) exhibited 42 oral mucosal lesions (24 were candidiasis); 86.0% (95% CI = 82.6-89.3) of children had DMFdefT ≥ 1. The presence of oral mucosal lesions was independently associated with CD4 count < 350 cells/mm(3) (POR = 2.96, 95% CI = 1.06-4.36) and poor oral hygiene (POR = 2.69, 95% CI = 1.07-6.76)., Conclusions: Oral mucosal lesions still occur in HIV-infected African children despite ART, but rarely. However, dental caries were common and severe in this population, reflecting the need to include oral health in the comprehensive care of HIV., (© 2014 John Wiley & Sons Ltd.)

Background: Barodontalgia is dental pain triggered by a change in barometric pressure and can be severe enough to cause in-flight incapacitation. There is a large variation of in-flight barodontalgia incidence in the literature and most of the current epidemiological data on barodontalgia has been compiled from military aircrew. The aim of this study was to evaluate the frequency of barodontalgia in French military and civilian aircrew., Methods: A cross-sectional study was conducted in 2010. The pilots and crewmembers attending 10 medical units of the French Air Force and Navy, and 5 dedicated to civilian pilots and aircrew were given a standardized and anonymous questionnaire to complete regarding demographic and professional characteristics as well as their barodontalgia., Results: Out of the 1475 questionnaires distributed, 1184 responded (response rate of 80.3%), and 6.6% of these participants (N = 74) reported at least one event of barodontalgia during their career (95% CI: 5.1-8.1%); 43 (6.8%) from the air force and 31 (6.5%) from a civilian service. Median pain intensity during barodontalgia was evaluated at 5.5 out of 10. Pain appeared most commonly during descent (47.3%) and was more frequent below 8000 m. In 10 cases (13.5%), the pilots reported that barodontalgia could have compromised flight security., Discussion: Despite the improvement of aeronautical equipment and the quality of dental care, barodontalgias were still present in 2010 in the French military and in civilian aircrews. We recommend prevention programs be established in order to minimize the frequency of barodontalgias and their potential repercussions on flight safety.

Background: Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA., Methods/design: The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group.The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the Geriatric Oral Health Assessment Index) will also be compared between the two groups., Discussion: Evidence-based management of potential aggravating factors in subjects with active RA could be of clinical importance, yet there are few randomized controlled trials on the effect of periodontal treatment on the clinical parameters of RA. The ESPERA trial is designed to determine if non-surgical periodontal treatment could improve clinical outcomes in patients with active RA, and the quality of life of these patients., Trial Registration: The ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06.

Introduction: We studied the frequency of documentation of disclosure of HIV status in medical charts and its correlates among HIV-infected adolescents in 2009, in Abidjan, Côte d'Ivoire., Methods: The PRADO-CI is a cross-sectional study aimed at studying HIV-infected adolescents' social, psychological, and behavioural difficulties and their determinants in Abidjan, Côte d'Ivoire. In this study, we present specific analyses on disclosure. All HIV-infected adolescents aged 13-21 years and followed at least once in 2009 in two urban HIV-care centres in Abidjan (Cepref and Yopougon Teaching Hospital) were enrolled in the study. Standardized data were extracted from medical records to document if there was notification of disclosure of HIV status in the medical record. Frequency of notification of HIV disclosure was estimated with its 95% confidence interval (CI) and correlates were analyzed using logistic regression., Results: In 2009, 229 adolescents were included: 126 (55%) males; 93% on antiretroviral therapy (ART), 61% on cotrimoxazole prophylaxis. Their median age was 15 years at the time of the study. Among the 193 patients for whom information on HIV status disclosure was documented (84%), only 63 (32.6%; 95% CI=26.0-39.3%) were informed of their status. The proportion of adolescents informed increased significantly with age: 19% for 13-15 years, 33% for 16-18 years and 86% for 19-21 years (p <0.0001). Adolescents on ART tended to be more likely to be informed of their HIV status (34.5%) than those not treated (13.3%) (p=0.11). Those on cotrimoxazole were significantly more likely to be informed (39.6%) than those not (21.9%) (p=0.01). Disclosure was significantly higher in adolescents with a history of ART regimen change (p=0.003) and in those followed in the Cepref (48.4%) compared to the Yopougon Teaching Hospital (24.8%), (p=0.001). In multivariate analyses, disclosed HIV status was significantly higher in those followed-up in the Cepref compared to the other centre: adjusted odds ratio (aOR)=3.5 (95% CI: 1.1-10.9), and among older adolescents compared to those aged 13-15 years: [16-18 years] aOR=4.2 (95% CI: 1.5-11.5) and [>18 years]: aOR=22.1 (95% CI: 5.2-93.5)., Conclusions: HIV disclosure rate was low among Ivoirian HIV adolescents and was site- and age-dependent. There is a need for practical interventions to support HIV disclosure to adolescents which provides age-appropriate information about the disease.

Background: HIV-2 is endemic in West Africa. There is a lack of evidence-based guidelines on the diagnosis, management and antiretroviral therapy (ART) for HIV-2 or HIV-1/HIV-2 dual infections. Because of these issues, we designed a West African collaborative cohort for HIV-2 infection within the framework of the International epidemiological Databases to Evaluate AIDS (IeDEA)., Methods: We collected data on all HIV-2 and HIV-1/HIV-2 dually seropositive patients (both ARV-naive and starting ART) and followed-up in clinical centres in the IeDEA-WA network including a total of 13 clinics in five countries: Benin, Burkina-Faso Côte d'Ivoire, Mali, and Senegal, in the West Africa region., Results: Data was merged for 1,754 patients (56% female), including 1,021 HIV-2 infected patients (551 on ART) and 733 dually seropositive for both HIV-1 and HIV 2 (463 on ART). At ART initiation, the median age of HIV-2 patients was 45.3 years, IQR: (38.3-51.7) and 42.4 years, IQR (37.0-47.3) for dually seropositive patients (p = 0.048). Overall, 16.7% of HIV-2 patients on ART had an advanced clinical stage (WHO IV or CDC-C). The median CD4 count at the ART initiation is 166 cells/mm(3), IQR (83-247) among HIV-2 infected patients and 146 cells/mm(3), IQR (55-249) among dually seropositive patients. Overall, in ART-treated patients, the CD4 count increased 126 cells/mm(3) after 24 months on ART for HIV-2 patients and 169 cells/mm(3) for dually seropositive patients. Of 551 HIV-2 patients on ART, 5.8% died and 10.2% were lost to follow-up during the median time on ART of 2.4 years, IQR (0.7-4.3)., Conclusions: This large multi-country study of HIV-2 and HIV-1/HIV-2 dual infection in West Africa suggests that routine clinical care is less than optimal and that management and treatment of HIV-2 could be further informed by ongoing studies and randomized clinical trials in this population.

Objective: We assessed the effect of HIV status disclosure on retention in care from initiation of antiretroviral therapy (ART) among HIV-infected children aged 10 years or more in Cote d'Ivoire, Mali and Sénégal., Methods: Multi-centre cohort study within five paediatric clinics participating in the IeDEA West Africa collaboration. HIV-infected patients were included in this study if they met the following inclusion criteria: aged 10-21 years while on ART; having initiated ART ≥ 200 days before the closure date of the clinic database; followed ≥ 15 days from ART initiation in clinics with ≥ 10 adolescents enrolled. Routine follow-up data were merged with those collected through a standardized ad hoc questionnaire on awareness of HIV status. Probability of retention (no death or loss-to-follow-up) was estimated with Kaplan-Meier method. Cox proportional hazard model with date of ART initiation as origin and a delayed entry at date of 10th birthday was used to identify factors associated with death or loss-to-follow-up., Results: 650 adolescents were available for this analysis. Characteristics at ART initiation were: median age of 10.4 years; median CD4 count of 224 cells/mm³ (47% with severe immunosuppression), 48% CDC stage C/WHO stage 3/4. The median follow-up on ART after the age of 10 was 23.3 months; 187 adolescents (28.8%) knew their HIV status. The overall probability of retention at 36 months after ART initiation was 74.6% (95% confidence interval [CI]: 70.5-79.0) and was higher for those disclosed compared to those not: adjusted hazard ratio for the risk of being death or loss-to-follow-up = 0.23 (95% CI: 0.13-0.39)., Conclusion: About 2/3 of HIV-infected adolescents on ART were not aware of their HIV status in these ART clinics in West Africa but disclosed HIV status improved retention in care. The disclosure process should be thus systematically encouraged and organized in adolescent populations.

Background: With 2.1 million HIV-infected children in 2008 in the world, especially in sub-Saharan Africa, the paediatric HIV/AIDS care remains an important public health challenge and is principally based on cotrimoxazole prophylaxis and antiretroviral treatments. This paper aims to review the effectiveness of cotrimoxole prophylaxis and antiretroviral treatment in HIV-infected children in Africa, specifically mortality and treatment outcomes., Methods: In two times, we searched the online databases PubMed™ and Scopus™ for articles and abstracts published in English and French between January 2004 and November 2009, with the following terms : « HIV » and « Africa » and ["paediatric" or "children" or "child"] and ["mortality" or "survival"] and ["cotrimoxazole" or "prophylaxis"] at the first time, « HIV » and « Africa » and ["paediatric" or "children" or "child"] and ["mortality" or "survival"] and ["antiretroviral"] and ["treatment" or "therapy"] at the second time. Longitudinal studies on HIV-infected children under cotrimoxazole prophylaxis or antiretroviral treatment were selected when survival outcomes were reported., Results: The probability of death was significantly reduced by 43% where children received cotrimoxazole prophylaxis compared to placebo. Compared to the survival without treatment, the benefit of antiretroviral therapy on HIV-infected children survival was evident in all publications but early mortality was observed within the six first months of antiretroviral treatment. Over fifty percent of deaths occurred in this period. Severe malnutrition, anaemia and lower CD4% were identified as mortality predicting factors in both children received cotrimoxazole prophylaxis or treated by antiretroviral therapy., Discussion: Better knowledge of determinants of early mortality for these children are important to optimized their survival and improve their quality of care and life. Finally, the beneficial effect of cotrimoxazole prophylaxis when associated with antiretroviral treatment has not been reported and need to be exploring in detail for more information., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

The objective of this study was to investigate for the first time tenofovir (TFV) pharmacokinetics in plasma and peripheral blood mononuclear cells (PBMCs) of the neonate. HIV-1-infected pregnant women received two tablets of tenofovir disoproxil fumarate (TDF; 300 mg) and emtricitabine (FTC; 200 mg) at onset of labor and then one tablet daily for 7 days postpartum. A single dose of 13 mg/kg of body weight of TDF was administered to 36 neonates within 12 h of life after the HIV-1-infected mothers had been administered two tablets of TDF-emtricitabine at delivery. A total of 626 samples collected within the 2 days after the drug administration were measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and analyzed by a population approach. In the neonate, the median TFV plasma area under the curve and minimal and maximal concentrations, respectively, were 3.73 mg/liter · h and 0.076 and 0.29 mg/liter. In PBMCs, TFV concentrations were detectable in all fetuses, whereas tenofovir diphosphate (TFV-DP) was quantifiable in only two fetuses, suggesting a lag in appearance of TFV-DP. The median TFV-DP neonatal concentration was 146 fmol/10⁶ cells (interquartile range [IQR], 53 to 430 fmol/10⁶ cells); two neonates had very high TFV-DP concentrations (1,530 and 2963 fmol/10⁶ cells). The 13-mg/kg TDF dose given to neonates produced plasma TFV and intracellular active TFV-DP concentrations similar to those in adults. This dose should be given immediately after birth to reduce the delay before the active compound TFV-DP appears in cells.

Our objective was to investigate neonatal emtricitabine (FTC) plasma and intracellular pharmacokinetics. The study was designed as a phase I/II prospective trial in two sequential steps evaluating the combination of tenofovir disoproxil fumarate (TDF) and FTC for the prevention of mother-to-child-transmission (PMTCT) of HIV. HIV-1-infected pregnant women received two tablets of TDF (300 mg) and FTC (200 mg) at onset of labor and then one tablet daily for 7 days postpartum. Based on the data obtained in the first part of the Tenofovir/Emtricitabine in Africa and Asia (TEmAA) Study, single doses of 2 mg/kg of FTC and 13 mg/kg of TDF were given to the neonates within 12 h after birth. A total of 540 FTC plasma concentrations and 44 active intracellular phosphorylated metabolite FTC-TP concentrations were taken from the 36 enrolled women and their neonates. Concentrations were measured by the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and analyzed by a population approach. The proposed dose obtained by simulations based on plasma drug concentrations was confirmed. However, median FTC-TP exposures were, respectively, 5.9 and 6.8 times higher in the fetus and the neonate than in the adult. High FTC-TP concentrations were observed in the four children who had serious adverse events (SAEs), but the link between FTC-TP concentrations and SAEs in children was not formally identified. The exposure to the active form of FTC was high in neonates despite plasma drug concentrations equivalent to those in adults. Our results are similar to those obtained with zidovudine or lamivudine.

The aim was to evaluate emtricitabine (FTC) and tenofovir (TFV) neonatal ingestion through breast milk. Median TFV and FTC breast milk doses represented 0.03% and 2%, respectively, of the proposed oral infant doses. Neonatal simulated plasma concentrations were extremely low for TFV but between the half-maximal inhibitory concentration and the adult minimal expected concentration for FTC. The rare children who will acquire HIV despite TDF-FTC therapy will need to be monitored for viral resistance acquisition.

The aim of the present study was to describe the nevirapine (NVP) pharmacokinetics (PK) in pregnant women and their neonates and to evaluate the transplacental drug transfer and administration scheme for the prevention of mother-to-child transmission. Thirty-eight HIV-1-infected pregnant women were administered one tablet of NVP (200 mg) and two tablets of tenofovir-emtricitabine (Truvada) at the initiation of labor. Children were given NVP syrup (2 mg/kg of body weight) as a single dose (sdNVP) on the first day of life. By pair, NVP concentrations were measured in 11 maternal, 1 cord blood, and 2 neonatal plasma samples and analyzed by a population approach. A one-compartment model was used for mothers and neonates; the absorption rate constants for mothers and neonates were 0.95 h(-1) (intersubject variability, 111%) and 0.39 h(-1), respectively; the apparent elimination clearances were 1.42 liter·h(-1) (intersubject variability, 22%) and 0.035 liter·h(-1), respectively; and apparent volumes of distribution were 87.3 liters (intersubject variability, 25%) and 5.65 liters, respectively. An effect compartment was linked to maternal circulation by mother-to-cord and cord-to-mother rate constants of 1.10 h(-1) and 1.43 h(-1), respectively. Placental transfer, expressed as the fetal-to-maternal area under the curve ratio, was 75%. Neonates had a very long half-lives (110 h) compared to adults. In the 38 mothers, the simulated median individual predicted time during which the NVP concentration remained above the half-maximal inhibitory concentration (IC(50)) was 13.2 days (range, 12 to 19.2 days). Thus, the administration of tenofovir-emtricitabine for at least 3 weeks after delivery should be considered to prevent the emergence of resistant viruses. The neonate must receive sdNVP immediately after birth when the infant is born less than 30 min after maternal drug intake to keep NVP concentrations above the IC(50).

Objective: Viral resistance occurs with a high frequency after single-dose nevirapine. We aimed to evaluate the tolerance and resistance profiles of a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) given to HIV-1-infected delivering women and their newborns., Design: An open-label phase I/II trial in Cambodia, Côte d'Ivoire and South Africa., Methods: HIV-1-infected pregnant women received zidovudine from the enrollment until the beginning of labor, when single-dose nevirapine and two tablets of TDF/FTC were given. One daily tablet of TDF/FTC was then administered for 7 days postpartum. All infants received single-dose nevirapine with single-dose TDF (13 mg/kg) and single-dose FTC (2 mg/kg) and 1 week of zidovudine. Mothers and infants were followed for 2 months. Serious adverse events, kinetic of maternal plasma HIV-1 RNA, pediatric HIV infection and genotypic resistance and viral subtype were assessed., Results: Thirty-six HIV-1-infected pregnant women were enrolled: median age 28 years (interquartile range: 26-31 years), median CD4 cell count 462 cells/μl (interquartile range: 376-632) and median HIV-1 RNA 3.7 log10 copies/ml (interquartile range: 2.95-4.11). Two infants had clinical serious adverse events, including one who died (neonatal sepsis). One transient grade 3 neutropenia and two grade 3/4 hyperbilirubinemia were also reported in neonates. One HIV pediatric in-utero infection was diagnosed (2.8%; 95% confidence interval 0-15.4%). Genotypic viral resistance to nevirapine was detected in one mother out of 34 (2.9%) at one month postpartum, but was also detectable at enrollment., Conclusion: The combination of TDF/FTC to delivering women and their neonates appears well tolerated and to minimize the occurrence of nevirapine viral resistance.

Background: Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis., Methods: The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups., Discussion: The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies., Trial Registration: Current Controlled Trials ISRCTN15334496.

Objective: Viral resistance occurs with high frequency after single-dose nevirapine. We aimed to evaluate the safety and resistance profiles of a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) in HIV-1-infected pregnant women and their newborns., Design: An open-label phase I/II trial in Côte d'Ivoire, Cambodia and South Africa., Methods: Women received antenatal zidovudine, intrapartum single-dose nevirapine and two tablets of TDF/FTC and one daily tablet of TDF/FTC during the 7 days postpartum. Their infants received single-dose nevirapine and zidovudine for 1 week. Serious adverse events (SAEs), kinetic of maternal plasma HIV-1 RNA viral load, genotypic resistance at 28 days postpartum and paediatric HIV-1 infection at 3, 28 and 45 days of life were assessed., Results: Thirty-eight HIV-1-infected pregnant women were enrolled (19 in Abidjan, 12 in Phnom Penh and seven in Soweto) with a median CD4 cell count of 450 cells/microl and median viral load of 4.08 log10 copies/ml. Women received TDF/FTC 4.9 h in median before delivery. Biological SAEs occurred in nine women. Among 39 live births, nine infants had clinical SAEs, including four deaths, and two developed severe anaemia. These SAEs were not likely to be related to TDF/FTC. Maternal viral load decreased by a median of 0.90 log10 copies/ml at 2 days postpartum and returned to baseline value at 28 days. No intrapartum HIV transmission was reported. No genotypic resistance mutation to zidovudine, nevirapine, FTC or TDF was detected., Conclusion: The TDF/FTC combination was well tolerated in delivering women and exposed newborns. Nevirapine viral resistance appears to have been avoided by the intrapartum and 7-day postpartum TDF/FTC regimen.

The objectives of this study were to evaluate emtricitabine (FTC) pharmacokinetics in pregnant women and their neonates and to determine the optimal prophylactic dose for neonates after birth to prevent mother-to-child transmission of human immunodeficiency virus (HIV). A total of 38 HIV-infected pregnant women were administered tenofovir disoproxyl fumarate (300 mg)-FTC (200 mg) tablets-two tablets at the initiation of labor and one daily for 7 days postpartum. By pair, 11 maternal, one cord blood, and two neonatal FTC concentrations were measured using a high-performance liquid chromatography-tandem mass spectrometry validated method and analyzed by a population approach. Model and mean estimates (interpatient variability) were a two-compartment model for mothers, with an absorption rate constant of 0.54 h(-1) (61%), apparent elimination and intercompartmental clearances of 23.2 (17%) and 6.04 liters x h(-1), and apparent central and peripheral volumes of 127 and 237 liters, respectively; an effect compartment linked to maternal circulation for cord blood and a neonatal compartment disconnected, after delivery, with a 10.6-h half-life (30%). After the 400-mg FTC administration, the median population area under the concentration-time curve and the minimal and maximal plasma FTC concentrations in pregnant women were 14.3 mg x liter(-1) x h and 1.68 and 0.076 mg/liter, respectively. At delivery, median (range) predicted maternal and cord blood FTC concentrations were, respectively, 1.16 (0.14 to 1.99) and 0.72 (0.05 to 1.19) mg x liter(-1). We concluded that the 400-mg FTC administration in pregnant women produces higher exposition than does the 200-mg administration in other adults, at steady state. FTC was shown to have good placental transfer (80%). Administering 1 mg FTC/kg as soon as possible after birth or 2 mg/kg 12 h after birth should produce neonatal concentrations comparable to the concentrations observed in adults.

Purpose of Review: With the large international mobilization against HIV/AIDS, more HIV-infected people in resource-limited settings have access to antiretroviral therapy, including pregnant women. The relevance of simplified prophylactic antiretroviral regimens for the prevention of mother-to-child transmission of HIV may become questionable due to their lower efficacy and their higher risk of inducing viral resistance than fully suppressive antiretroviral therapy., Recent Findings: Field implementation of current recommendations, impact of prophylactic regimens on subsequent antiretroviral therapy response and possible new indications of antiretroviral therapy in pregnant women will be reviewed in this paper., Summary: Prophylactic antiretroviral prevention of mother-to-child transmission regimens reached only 10% of the HIV-infected pregnant women in 2006, who were usually offered single-dose nevirapine only. The operational links between antenatal care and antiretroviral therapy programmes can now be documented and demonstrate good results in terms of safety and efficacy. The negative impact of single-dose nevirapine exposure on subsequent first-line antiretroviral therapy appears worse for mothers with advanced HIV disease at the time of delivery and short interval before antiretroviral therapy initiation. Strengthening the links between antenatal care and antiretroviral therapy programmes is critical for antiretroviral therapy-eligible HIV-infected pregnant women in terms of prevention of mother-to-child transmission and subsequent antiretroviral therapy response. The breastfeeding period could be a new indication for antiretroviral therapy in this population.

Background: Single-dose nevirapine (NVP) is the main option for the prevention of mother-to-child transmission (PMTCT) of HIV-1 in countries with limited resources. However, the use of single-dose NVP results in HIV-1 viral resistance which could compromise the success of subsequent treatment of mother and child with antiretroviral combinations that include non-nucleosidic-reverse-transcriptase inhibitors. This systematic review and meta-analysis of summarized data aimed to estimate the proportion of mothers and children with NVP resistance mutations detected in plasma samples 4-8 weeks postpartum after single-dose NVP use for PMTCT., Methods: Systematic search of electronic databases (MEDLINE, PASCAL) and conference proceedings (1997 to February 2006). Inclusion of all studies, without design, place or language restrictions, meeting the following criteria: use of single-dose NVP; viral genotyping performed with standard sequence analyses, between 4 and 8 weeks postpartum, in plasma samples; available public report; report of mothers' median baseline plasma HIV-1 RNA levels. Data extraction by two independent reviewers using a standardized form created for this purpose. Logistic random effect models to obtain pooled estimates. Univariable and multivariable meta-regression to explore sources of heterogeneity., Results: The pooled estimate of NVP resistance prevalence was 35.7% [95% confidence interval (CI) 23.0-50.6] in women in 10 study arms using single-dose NVP +/- other antepartum antiretrovirals and 4.5% (CI 2.1-9.4) in three study arms providing also postpartum antiretrovirals (adjusted odds ratio 0.08; CI 0.04-0.16). The corresponding estimates in children were 52.6% (CI 37.7-67.0) in seven study arms using single-dose NVP only and 16.5% (CI 8.9-28.3) in eight study arms combining single-dose NVP with other antiretrovirals., Conclusions: Single-dose NVP is widely used for PMTCT in resource-poor settings, but the burden of viral resistance is high in both women and children. It is substantially lower in studies providing additional postpartum antiretrovirals. The clinical implications of these findings should be further investigated.

Child health in developing countries is a public health priority both at the national and international level. The World Health Organization, UNICEF and other technical partners have developed The Integrated Management of Childhood Illness (IMCI) strategy to reduce child mortality and improve child health and development through a holistic approach. By the end of 2002, 109 countries among which 17 in the region of the Americas and Caribbean had adopted and implemented this strategy,. In this region, Haiti presents the highest mortality rate for under-fives. Every year, more than 138,000 children die of diseases such as malaria, pneumonia, diarrhea, measles and perinatal complications. Malnutrition contributes to a high percentage of these deaths. It is recognised that the mortality due to these diseases can be prevented. To fight this burden, Haiti officially adopted the IMCI strategy in 1997. The objectives of this paper are, after a general overview of the IMCI strategy, to describe Haiti's child health and analyse the achievements of the first steps of implementing the IMCI strategy in Haiti. The methodology used was a standardised literature review and a qualitative survey based on semi-structured interviews of national and local health authorities involved in the implementation of the IMCI strategy in Haiti. Main results show a limited impact of the first and second phase of implementation in the country. The key factors for this have been limited economical and human resources. A unequal distribution of existing resources between the different IMCI strategy components especially community and family practices, has limited adequate coverage. Isolated actions in favour of child health as well as a lack of co-ordinated interventions between the various actors have been among the barriers for an adequate implementation of this strategy. We recognise that the approach used here is not a formal evaluation on the implementation of IMCI in Haiti. Nevertheless, we hope this article will contribute to draw the attention of national and international public health decision-makers on the difficulties of implementing this strategy in Haiti and in this way, improve child health in the country.