Response to "Being prepared to evaluate pregnancy PrEP".
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ABSTRACT:
SUBMITTER: Dettinger JC
PROVIDER: S-EPMC6929148 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
Publications
Response to "Being prepared to evaluate pregnancy PrEP".
Dettinger Julia C JC Kinuthia John J Pintye Jillian J Baeten Jared M JM John-Stewart Grace G
Journal of the International AIDS Society 20191201 12
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| EMPIAR-10937 | biostudies-other
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| S-EPMC11332121 | biostudies-literature
Project description:IntroductionWomen who choose to conceive a baby with a partner living with HIV or a partner whose HIV serostatus is unknown in HIV-endemic settings need prevention strategies to mitigate HIV acquisition during conception and pregnancy.Methods and analysisWe are conducting a single-arm longitudinal study offering oral tenofovirdisoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) for periconception use to 350 HIV-uninfected women in KwaZulu-Natal, South Africa. PrEP is offered as part of woman-centred safer conception programme that promotes couples-based HIV counselling and testing, antiretroviral therapy for partners who are HIV-infected, treatment for sexually transmitted infections and safer conception strategies, such as limiting condomless sex to peak fertility. We enrol HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a partner living with HIV or of unknown serostatus, and personal or partner plans for pregnancy in the next 12 months. We follow enrolled women for 12 months. Women who become pregnant are followed through pregnancy outcome, independent of their decisions regarding PrEP use. The primary objective of the study is to evaluate the uptake of and adherence to PrEP during the periconception period and pregnancy. Secondary outcomes include the uptake of other safer conception strategies. We also measure clinical outcomes including HIV seroconversion rates and pregnancy and infant outcomes. Finally, we will explore conduct and evaluate qualitative interviews in 25 participants to further inform our conceptual framework for periconception PrEP uptake and adherence among HIV-exposed women in South Africa.Ethics and disseminationThe protocol has been approved by the Human Research Ethics Committee at the University of the Witwatersrand (Johannesburg, South Africa) and the Institutional Review Board of Partners Healthcare (Boston, Massachusetts, USA). Study findings will be made available to interested participants. Results will be presented to local health officials and stakeholders at meetings. Investigators will share the results at meetings and in manuscripts. De-identified quantitative data will be made available.Trial registration numberThe protocol is registered with the South African Health Products Regulatory Agency (SAHPRA, formerly known as the Medicine Controls Council, MCC#20170131) and ClinicalTrials.gov (NCT03194308); Pre-results.
| S-EPMC6661571 | biostudies-literature
Project description:IntroductionActive disease in inflammatory bowel disease patients during pregnancy is associated with poor maternal and fetal outcomes. Objective evaluation of disease activity is a core strategy in IBD, and during pregnancy noninvasive modalities are preferred. We aimed to evaluate feasibility and accuracy of intestinal ultrasound (IUS) to objectify disease activity throughout pregnancy.MethodsPregnant patients with known IBD were included and followed throughout pregnancy for clinical disease activity, with fecal calprotectin (FCP) and with IUS every trimester. Feasibility of IUS was assessed for all colonic segments and terminal ileum (TI). Intestinal ultrasound outcomes to detect active disease and treatment response were compared with clinical scores combined with FCP.ResultsIn total, 38 patients (22 CD, 16 UC) were included, with 27 patients having serial IUS. Feasibility of IUS decreases significantly in third trimester for TI (first vs third trimester: 91.3% vs 21.7%, P < .0001) and sigmoid (first vs third trimester: 95.6% vs 69.5%, P = .023). Intestinal ultrasound activity showed moderate to strong correlation with clinical activity (r = 0.60, P < .0001) and FCP (r = 0.73, P < .0001). Throughout pregnancy, IUS distinguished active from quiescent disease with 84% sensitivity and 98% specificity according to FCP combined with clinical activity. IUS showed disease activity in >1 segment in 52% of patients and detected treatment response with 80% sensitivity and 92% specificity.ConclusionsIUS is feasible and accurate throughout pregnancy, although visualization of the sigmoid and TI decreases in the third trimester. IUS provides objective information on disease activity, extent, and treatment response, even during second and third trimester, and offers a noninvasive strategy to closely monitor patients during pregnancy.
| S-EPMC9247844 | biostudies-literature
Project description:INTRODUCTION:The World Health Organization, while recommending pre-exposure prophylaxis (PrEP) for HIV-negative pregnant and postpartum women in HIV high-burden settings, advocates for continued safety evaluation of PrEP in this population. METHODS:The PrEP Implementation in Young Women and Adolescents (PrIYA) program delivered PrEP to pregnant and postpartum women integrated within routine maternal and child health clinics (MCH) at 16 sites in Western Kenya. PrEP exposure and perinatal outcome data were collected among women obtaining postnatal services during programme evaluation. PrEP use was self-reported and confirmed with clinical records. Perinatal outcomes including gestational age at birth, birthweight, congenital malformations and infant growth outcomes were abstracted from clinical records for mother-infant pairs attending the six week visit. Associations between infant outcomes and maternal prenatal PrEP use were assessed using univariate and multivariate logistic and linear regression. RESULTS:The PrIYA evaluation identified 1530 postpartum mother-infant pairs with data on prenatal PrEP exposure: 206 with prenatal PrEP use, 1324 without. Median maternal age was 24 years in both groups. PrEP users (any reported PrEP use) were significantly more likely to report HIV risk factors such as: intimate partner violence, sexually transmitted infections and having a partner with positive or unknown HIV status. Most mothers initiated PrEP during the second trimester (n = 116, 57%) and used PrEP for more than one month (n = 110, 58%). The mean birthweight was 3.3 kg and gestational age at birth was 38.5 weeks in both groups. There were no major differences between PrEP exposed and unexposed infants in rates of preterm birth and low birthweight. There were no congenital malformations identified in the PrEP-exposed group and five reported in the PrEP unexposed group. At six weeks postpartum, infants in both groups had similar growth. No differences in infant outcomes were found by duration PrEP exposure, trimester of PrEP initiation, a subset analysis of women 15 to 24 years old or in multivariate analyses. This analysis demonstrates that monitoring of infant outcomes is feasible within large-scale programmatic implementation of PrEP among pregnant and postpartum populations. CONCLUSIONS:Pregnancy outcomes and early infant growth did not differ by PrEP exposure.
| S-EPMC6733245 | biostudies-literature
Project description:Human gut microbiota from pre and post-PrEP specimens
| PRJEB29018 | ENA
Project description:Non-targeted analysis (NTA) methods are increasingly used to discover contaminants of emerging concern (CECs), but the extent to which these methods can support exposure and health studies remains to be determined. EPA's Non-Targeted Analysis Collaborative Trial (ENTACT) was launched in 2016 to address this need. As part of ENTACT, 1269 unique substances from EPA's ToxCast library were combined to make ten synthetic mixtures, with each mixture containing between 95 and 365 substances. As a participant in the trial, we first performed blinded NTA on each mixture using liquid chromatography (LC) coupled with high-resolution mass spectrometry (HRMS). We then performed an unblinded evaluation to identify limitations of our NTA method. Overall, at least 60% of spiked substances could be observed using selected methods. Discounting spiked isomers, true positive rates from the blinded and unblinded analyses reached a maximum of 46% and 65%, respectively. An overall reproducibility rate of 75% was observed for substances spiked into more than one mixture and observed at least once. Considerable discordance in substance identification was observed when comparing a subset of our results derived from two separate reversed-phase chromatography methods. We conclude that a single NTA method, even when optimized, can likely characterize only a subset of ToxCast substances (and, by extension, other CECs). Rigorous quality control and self-evaluation practices should be required of labs generating NTA data to support exposure and health studies. Accurate and transparent communication of performance results will best enable meaningful interpretations and defensible use of NTA data. Graphical abstract ᅟ.
| S-EPMC6469933 | biostudies-literature
Project description:Background: Pregnant and postpartum women in high HIV prevalent regions are at increased HIV risk. Oral pre-exposure prophylaxis (PrEP) can decrease HIV incidence reducing infant HIV infections. Understanding healthcare worker (HCW) beliefs about PrEP prior to national roll-out is critical to supporting PrEP scale-up. Methods: We conducted 45 semi-structured interviews among a range of HCW cadres with and without PrEP provision experience purposively recruited from four clinics in Kenya to compare their views on prescribing PrEP during pregnancy and postpartum. Interviews were analysed using a conventional content analysis approach to identify key influences on PrEP acceptability and feasibility. Results: All HCWs perceived PrEP as an acceptable and feasible HIV prevention strategy for pregnant and postpartum women. They believed PrEP meets women's needs as an on-demand, female-controlled prevention strategy that empowers women to take control of their HIV risk. HCWs highlighted their role in PrEP delivery success while acknowledging how their knowledge gaps, concerns and perceived PrEP implementation challenges may hinder optimal PrEP delivery. Conclusion: HCWs supported PrEP provision to pregnant and postpartum women. However, counseling tools to address risk perceptions in this population and strategies to reduce HCW knowledge gaps, concerns and perceived implementation barriers are required.
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Project description: Not available
| S-EPMC11421954 | biostudies-literature