Factors associated with the acceptability of Lopinavir/Ritonavir formulations among children living with HIV/AIDS attending care and treatment clinics in Mbeya and Mwanza, Tanzania
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ABSTRACT:
SUBMITTER: Jiwa N
PROVIDER: S-EPMC10760675 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:OBJECTIVE:This study was done to determine the patterns of Candida spp. causing vaginitis and associated factors among pregnant women attending antennal clinic in Mwanza, Tanzania. RESULTS:A total of 197 (65.6%) out of 300 non-repetitive swabs had positive growth of Candida spp. Candida albicans 125 (63.4%) was the most predominant isolated specie followed by C. tropicalis 35 (17.8%) and C. glabrata 33 (16.8%). Laboratory confirmed candida vaginitis was independently predicted by douching practices (OR 3.2, 95% CI 1.3-7.5 P = 0.007), history of antibiotics use (OR 1.8, 95% CI 1.02-3.0, P = 0.04) and low social economic status (OR 2.04, 95% CI 1.1-3.7 P = 0.02). About two-third of pregnant women with clinical features of vaginitis attending antenatal clinic in Mwanza, Tanzania were confirmed to have Candida vaginitis mainly caused by Candida albicans.
| S-EPMC6881989 | biostudies-literature
Project description:Anaemia is a global public health issue, disproportionately affecting vulnerable populations such as pregnant women. The aim of this study was to assess the prevalence of anaemia and to identify factors associated with the condition among pregnant women attending antenatal clinics in the Mbeya Region of Tanzania. A cross sectional study was conducted with 420 pregnant women (<28 weeks of gestation) attending antenatal visits in the 7 districts of the Mbeya Region. A structured questionnaire was used to collect demographic information and eating habits using a 24hours dietary recall. A blood sample was collected and tested for hemoglobin content using the HemoCue 201+. Multivariate analysis was performed using standard logistic regression to explore the association between anaemia status with socio-demographic, reproductive and nutritional factors. Overall prevalence of anaemia in pregnant women was 25.5%. Out of 107 pregnant women diagnosed with anaemia and, sixty six had mild anaemia. In a multivariate logistical regression analysis anaemic women was associated with pregnant women coming from lower socio-economic status [adjusted OR = 2.40, 95%CI (1.05, 5.48)]. Moreover, anaemia was less associated with pregnant women who were living in Mbeya district council [adjusted OR = 0.28, 95%CI (0.11, 0.72)], consume at least once a day dark green leafy vegetables [adjusted OR = 0.53, 95% CI (0.30, 0.94)], and vegetable liquid cooking oil [adjusted OR = 0.56, 95% CI (0.34, 0.98)]. The prevalence of anaemia among the pregnant women falls in the category of moderate public health problem according to the WHO classification. Low socio-economic status, consumption of green leafy vegetables and vegetable liquid cooking oil were significantly and independently associated with anaemia during pregnancy. Thus, special attention should be given to pregnant women who are in lower socio-economic status and those not consuming vegetables. Interventions that integrate health and nutrition education in reproductive and child health clinics are needed to combat anaemia.
| S-EPMC10021601 | biostudies-literature
Project description:Lopinavir/ritonavir (LPV/r) is recommended by the World Health Organization as first-line treatment for HIV-infected infants and young children. We performed a composite population pharmacokinetic (PK) analysis on LPV plasma concentration data from 6 pediatric and adult studies to determine maturation and formulation effects from infancy to adulthood. Intensive PK data were available for infants, children, adolescents, and adults (297 intensive profiles/1662 LPV concentrations). LPV PK data included 1 adult, 1 combined pediatric-adult, and 4 pediatric studies (age 6 weeks to 63 years) with 3 formulations (gel-capsule, liquid, melt-extrusion tablets). LPV concentrations were modeled using nonlinear mixed effects modeling (NONMEM v. 7.3; GloboMax, Hanover, Maryland) with a one compartment semiphysiologic model. LPV clearance was described by hepatic plasma flow (QHP ) times hepatic extraction (EH ), with EH estimated from the PK data. Volume was scaled by linear weight (WT/70)1.0 . Bioavailability was assessed separately as a function of hepatic extraction and the fraction absorbed from the gastrointestinal tract. The absorption component of bioavailability increased with age and tablet formulation. Monte Carlo simulations of the final model using current World Health Organization weight-band dosing recommendations demonstrated that participants younger than 6 months of age had a lower area under the drug concentration-time curve (94.8 vs >107.4 μg hr/mL) and minimum observed concentration of drug in blood plasma (5.0 vs > 7.1 μg/mL) values compared to older children and adults. Although World Health Organization dosing recommendations include a larger dosage (mg/m2 ) in infants to account for higher apparent clearance, they still result in low LPV concentrations in many infants younger than 6 months of age receiving the liquid formulation.
| S-EPMC6604805 | biostudies-literature
Project description:The development of formulation approaches to coadminister lopinavir and ritonavir antiretroviral drugs to children is necessary to ensure optimal treatment of human immunodeficiency virus (HIV) infection. It was previously shown that milk-based lipid formulations show promise as vehicles to deliver antimalarial drugs by enhancing their solubilization during the digestion of the milk lipids under intestinal conditions. In this study, we investigate the role of digestion of milk and infant formula on the solubilization behavior of lopinavir and ritonavir to understand the fate of drugs in the gastrointestinal (GI) tract after oral administration. Small angle X-ray scattering (SAXS) was used to probe the presence of crystalline drugs in suspension during digestion. In particular, the impact of one drug on the solubilization of the other was elucidated to reveal potential drug-drug interactions in a drug combination therapy. Our results showed that lopinavir and ritonavir affected the solubilization of each other during digestion in lipid-based formulations. While addition of ritonavir to lopinavir improved the overall solubilization of lopinavir, the impact of lopinavir was to reduce ritonavir solubilization as digestion progressed. These findings highlight the importance of assessing the solubilization of individual drugs in a combined matrix in order to dictate the state of drugs available for subsequent absorption and metabolism. Enhancement in the solubilization of lopinavir and ritonavir in a drug combination setting in vitro also supported the potential for food effects on drug exposure.
| S-EPMC10074382 | biostudies-literature
Project description:Background High-risk sexual behaviors(HRSBs) among young adults are key risk for Sexually Transmitted Infections(STIs), HIV and unplanned pregnancies. WHO has identified the 15-24years age-group as high-risk for STIs. Students at Higher Learning Institutions(HLIs) may be at higher risk because they are free of immediate parental-supervision, are a transient migratory population, probably at peak-years of sexual activity. In Tanzania, information is limited on sexual and preventive behaviours among young adults in HLIs. We describe risky sexual behaviours and preventive practices among young adults attending HLIs in Mbeya-Tanzania. Methods We conducted a cross-sectional study from March2019 to January2020 among randomly selected students aged 18-24years enrolled in HLIs within Mbeya. Probability proportional to size was used to determine total student number from each HLI. We used a self-administered questionnaire to collect information on sexual health education, activity, behaviour and STI knowledge. Results Total of 504students were enrolled with mean age of 21.5(SD 1.74)years. Total of 446(88.5%) students reported ever having had sex. Mean-age at first sex was 18.4years and 9.9% reported sexual debut <15years. A higher proportion of male students(57%) reported sexual debut with non-steady partners than females(37.9%). Lack of condom use at sexual debut was reported by 52% of the participants. Consistent condom use during past 4-weeks was reported at 33% and 16.5% among males and females, respectively. About 1 in 10 students reported forced sex by someone they were dating. Sex under the influence of alcohol was reported by 24% of the students. Nearly 8 in 10 (78.7%) students have heard of STIs, but only 16% were aware STIs can be asymptomatic. Conclusion STI prevention programs need to recognize young adults in HLIs as at-risk population; and advocate targeted messages to minimize risk to acquiring STIs, counseling and support for those experiencing sexual violence, promote condom use and safer-sex negotiation skills.
| S-EPMC10080207 | biostudies-literature
Project description:BackgroundWorldwide, 1.7 million children younger than 15 years were living with HIV in 2021. Only 52% of them had access to antiretrovirals (ARVs). Lack of age-appropriate ARV formulations (i.e. easy to swallow for young infants, acceptable taste) remains the main obstacle to the access to ARVs. Therefore, a strawberry-flavoured Abacavir/Lamivudine/Lopinavir/Ritonavir (30/15/40/10 mg) fixed-dose combination of granules in a capsule (4-in-1) for children living with HIV weighing 3-25 kg was developed.ObjectiveWe assessed caregivers' perceived acceptability of the 4-in-1 compared with previous paediatric ARV formulations and factors influencing acceptability.MethodsThis exploratory qualitative case study embedded in a phase I/II, open-label, randomized cross-over pharmacokinetic, safety and acceptability study (LOLIPOP) was conducted in three sites in Uganda (May 2019-October 2020). Thirty-six children weighing between 3 and 19.9 kg participated in the main study. We purposively sampled caregiver-child dyads according to weight bands, and conducted 20 semi-structured interviews with caregivers and 5 with healthcare providers. We triangulated these results with a quantitative acceptability questionnaire. We analysed interviews inductively using NVivo12 adopting a thematic analysis approach and acceptability questionnaires descriptively to assess concordance between them.ResultsAll caregivers found the 4-in-1 formulation highly acceptable and easier to use than previous formulations (i.e. pellets/tables/syrup). Appealing taste, ease of administration, easy storage and children's acceptance contributed to acceptability despite structural challenges of food shortage and HIV stigma. Visible improvements in children's health and comprehensive and tailored healthcare provider support to overcome initial difficulties such as vomiting increased caregivers' acceptance. Concordant results from questionnaire- and interview-data confirmed high acceptability.ConclusionCaregivers of children in all weight bands in this sample found the 4-in-1 granules highly acceptable compared with the pellets/tablets combination. Healthcare providers' support to caregivers allowed for individual tailoring of drug administration despite challenges such as food shortage. This enabled short-term adherence. These findings informed further practical recommendations.RegistrationClinical trial number: NCT03836833.
| S-EPMC10031622 | biostudies-literature
Project description:BackgroundAntenatal care (ANC) is crucial for reducing maternal morbidity and mortality, especially in low-resource settings. During antenatal care, women are provided with resources for enhancing their dietary diversity, like nutrition education and counseling. Improved nutrition knowledge influences positive nutritional behavior change, like women's improved dietary diversity, which may increase the likelihood of a healthier pregnancy and delivery experience.ObjectiveThis study aim was to assess dietary diversity and associated factors among pregnant women attending antenatal care in the Coast region of Tanzania.MethodsThe descriptive cross-sectional study design was used to assess dietary diversity and associated factors among 338 pregnant women. A semi-structured questionnaire collected information from pregnant women on social demographic characteristics, nutrition knowledge and dietary diversity. Women were classified as having a varied diet if they had consumed at least five of the ten food groups over the previous twenty-four hours. Multivariable logistic regression analyses were used to identify predictors of dietary diversity in pregnant women.ResultsOnly 28% (95% CI: 23.5-33.1) (n = 95) of pregnant women met the minimum dietary diversity, and 18% (95% CI: 13.8-21.9) (n = 59) were considered to have a high level of nutrition knowledge. Living near a health facility (AOR = 1.77, CI 1.02, 3.06), having high nutrition knowledge (AOR = 2.58, 95% CI: 1.36, 4.89), and being pregnant for the first time (AOR = 2.44, 95% CI: 1.09, 5.44) were associated with adequate dietary diversity.ConclusionPregnant women in the study were found to have low knowledge about nutrition and inadequate dietary diversity intake. The findings underscore the need to improve nutrition knowledge provision in antenatal clinics by emphasizing the importance of a diversified and high-quality diet. Healthcare providers in antenatal care clinics should consistently provide nutrition education and counseling to pregnant women and promote their diversified food consumption. Such knowledge may eventually promote healthier pregnancy and child development by curbing the nutritional deficiencies experienced during pregnancy.
| S-EPMC10801968 | biostudies-literature
Project description:The COVID-19 pandemic has claimed over six million lives and caused significant morbidities globally. The development and use of COVID-19 vaccines is a key strategy in ending this. There is a general public hesitancy on vaccine uptake, including pregnant women who are at high risk of severe forms of the disease and death when infected with the virus. To determine the magnitude of hesitancy toward COVID-19 vaccines and the associated factors among pregnant women attending public antenatal clinics in Dar es Salaam. This was a cross-sectional analytical study conducted among 896 pregnant women attending antenatal clinics at public health facilities in Dar es Salaam. A structured interviewer-based questionnaire, in an electronic form, was used. The analysis was done by a multivariable linear regression model using STATA 16 to obtain factors associated with vaccine hesitancy, and P < .05 was considered significant. The proportion of pregnant women with vaccine hesitancy was 45%. Hesitancy was higher among unemployed pregnant women (AOR 2.16 (95% CI 1.36-3.42) and the self-employed group (AOR 1.62 (95% CI 1.07-2.44). It was also higher among pregnant women with poor attitudes to COVID-19 vaccines (AOR 2.44 (95% CI 1.75-3.39) and women who had low perceived benefits of the vaccines (AOR 2.57 (95% CI 1.83-3.60). COVID-19 vaccine-targeted interventions should aim at the provision of knowledge on COVID-19 and the COVID-19 vaccine and address poor attitudes and perceptions that pregnant women have on these vaccines.
| S-EPMC10653711 | biostudies-literature
Project description:BackgroundProtease inhibitor-based antiretroviral therapy may be used in resource-limited settings in persons with human immunodeficiency virus and tuberculosis (HIV-TB). Data on safety, pharmacokinetics/pharmacodynamics (PK/PD), and HIV-TB outcomes for lopinavir/ritonavir (LPV/r) used with rifampin (RIF) or rifabutin (RBT) are limited.MethodsWe randomized adults with HIV-TB from July 2013 to February 2016 to arm A, LPV/r 400 mg/100 mg twice daily + RBT 150 mg/day; arm B, LPV/r 800 mg/200 mg twice daily + RIF 600 mg/day; or arm C, LPV/r 400 mg/100 mg twice daily + raltegravir (RAL) 400 mg twice daily + RBT 150 mg/day. All received two nucleoside reverse transcriptase inhibitors and other TB drugs. PK visits occurred on day 12 ± 2. Within-arm HIV-TB outcomes were summarized using proportions and 95% CIs; PK were compared using Wilcoxon tests.ResultsAmong 71 participants, 52% were women; 72% Black; 46% Hispanic; median age, 37 years; median CD4+ count, 130 cells/mm3; median HIV-1 RNA, 4.6 log10 copies/mL; 46% had confirmed TB. LPV concentrations were similar across arms. Pooled LPV AUC12 (157 203 hours × ng/mL) and Ctrough (9876 ng/mL) were similar to historical controls; RBT AUC24 (7374 hours × ng/mL) and Ctrough (208 ng/mL) were higher, although 3 participants in arm C had RBT Cmax <250 ng/mL. Proportions with week 48 HIV-1 RNA <400 copies/mL were 58%, 67%, and 61%, respectively, in arms A, B, and C.ConclusionsDouble-dose LPV/r+RIF and LPV/r+RBT 150mg/day had acceptable safety, PK and TB outcomes; HIV suppression was suboptimal but unrelated to PK. Faster RBT clearance and low Cmax in 3 participants on RBT+RAL requires further study.
| S-EPMC8366816 | biostudies-literature
Project description:BackgroundVaccine is the cost-effective and reliable public health intervention to combat the emerging COVID-19 pandemic. The vaccination is considered safe and effective at any stage of pregnancy; however, pregnant women show more vaccine hesitation than the general population. This study aims to assess pregnant women's awareness, perception, and acceptability of COVID-19 vaccine attending antenatal clinics.MethodsAn institutional-based cross-sectional analytical study design was used to assess the acceptance of the COVID-19 vaccine and associated factors among pregnant women between Feb-1 to March-30-2022 at antenatal clinics of Bharatpur Chitwan using systematic random sampling. A semi-structured interview schedule was used to collect data from 644 respondents. Collected data were analysed using descriptive and inferential statistics like the Pearson chi-square test and logistic regression analysis.ResultsThe COVID-19 vaccine acceptance was found to be 22% and ethnicity (AOR = 1.826; 95% CI = 1.215-2.745), education level (AOR = 1.773; 95%CI = 1.025-3,068;), history of COVID-19 infection (AOR = 3.63; 95% CI = 1.323-9.956;), number of child (AOR = 5.021; 95% CI 1.989-12.677;), trimester (week of pregnancy) (AOR = 2.437; 95% CI 1.107-5.366) and level of perception (AOR = 2.152; 95% CI 1.109-4.178) were found to be statistically significant for acceptance of COVID-19 vaccine among pregnant mother.ConclusionsIn this study, low levels of vaccine acceptance were found. Several influential factors like occupation, history of COVID-19 infection, number of pregnancies, week of gestation, and level of attitude were found to be significant for acceptance of COVID-19 vaccine among pregnant women. Everyone needs vaccine acceptance to get herd immunity and reduce the COVID-19 infection. But Vaccine hesitancy is one of the significant threats to the COVID-19 rollout and successful pandemic mitigation. Therefore, properly disseminating information and removing misperceptions about the COVID-19 vaccine is necessary to raise the acceptance.
| S-EPMC10016669 | biostudies-literature