Dataset Information

Understanding and optimizing brain health in HIV now: protocol for a longitudinal cohort study with multiple randomized controlled trials.

ABSTRACT: Chronic HIV infection commonly affects both cognition and mental health, even with excellent systemic viral control. The causes of compromised brain health are likely to be a multi-factorial combination of HIV-related biological factors, co-morbidities such as aging and cerebrovascular disease, and the erosion of coping skills, physical health, and social supports resulting from the strains of living with a chronic illness.This study aims to provide a better understanding of the relationship between cognitive complaints, depression, and objectively measured cognitive impairment in HIV, and of the key factors, whether biological or personal, which relate to these presentations and to their evolution over time. Characterization of this heterogeneity will permit more focused pathophysiological studies, and allow more targeted interventions. The project makes extensive use of Web-based research and health care delivery tools, aiming to provide cost-effective, "clinic ready" tools to improve brain health in HIV. This project has two overarching aims, reflecting our dual goals of understanding and improving brain health in HIV, focusing on cognitive impairment, its contributors and consequences. The objectives are to contribute evidence for the validity of a brief brain health assessment, to estimate the extent to which HIV-related cognition-relevant clinical factors and patient-centered outcomes inter-relate and evolve over time, allowing identification of the mechanisms underpinning longitudinal change in brain health and to contribute evidence for the feasibility, effectiveness potential, acceptability, and underlying mechanisms of promising interventions for optimizing brain health. We adopt a cohort multiple randomized control trials design. A total of 900 participants will be characterized prospectively over a 27-month period to answer questions about the evolution of outcomes of interest. All participants will be offered basic brain health self-management information. Sub-groups will participate in pilot studies of specific, more intensive interventions to provide pragmatic evidence for feasibility, effectiveness, and comparative effectiveness.This work will provide needed estimates of the burden, heterogeneity, evolution, and mechanisms underlying compromised brain health in HIV, and test a range of promising non-pharmacological interventions. This is an on-going study; the trials nested within this cohort that are currently recruiting participants were registered on 7 October 2015 (Clinicaltrials.gov NCT02571504 and NCT02571595).

SUBMITTER: Mayo NE

PROVIDER: S-EPMC4712501 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Understanding and optimizing brain health in HIV now: protocol for a longitudinal cohort study with multiple randomized controlled trials.

Mayo Nancy E NE Brouillette Marie-Josée MJ Fellows Lesley K LK

BMC neurology 20160114

<h4>Background</h4>Chronic HIV infection commonly affects both cognition and mental health, even with excellent systemic viral control. The causes of compromised brain health are likely to be a multi-factorial combination of HIV-related biological factors, co-morbidities such as aging and cerebrovascular disease, and the erosion of coping skills, physical health, and social supports resulting from the strains of living with a chronic illness.<h4>Methods/design</h4>This study aims to provide a be ...[more]

PMID: 26762403

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Project description:BackgroundIt is critical to identify children living with HIV and initiate lifesaving antiretroviral treatment (ART) early. The Pediatric Accelerated Case Finding Effort focused on contact elicitation and HIV testing of ART clients' biological children. We describe HIV testing and seropositivity rates following the initiative and gaps along the index testing cascade to inform pediatric HIV case finding optimization.MethodsThis mixed-methods study involved collecting monthly data on index testing outcomes, including elicitation (identifying biological children < 15 years), HIV testing and linkage to treatment from March 2020 to July 2021 in 35 facilities in Kinshasa. Data were summarized and presented for the first month (as a baseline proxy) and the entire study period. Qualitative data were collected from 14 healthcare workers participating in in-depth interviews and 33 community health workers in four focus group discussions. Audio recordings were transcribed and translated from Lingala or French into English and coded using MAXQDA software. Data were thematically analyzed according pediatric case finding barriers and strategies.ResultsAt baseline (March 2020), among 3337 eligible female index clients, 1634 (49.0%) underwent elicitation to identify children with unknown HIV status. By July 2021, all eligible clients (n = 11,734) had contacts identified. Of the contacts, 9871/11,848 (83.3%) were HIV-tested. Of contacts tested, 662 (6.7%) were diagnosed as HIV-positive, with 535 (80.8%) age 5-14 years; 99.5% initiated treatment. Providers attributed gaps in HIV testing primarily to testing refusals for children due to non-disclosure among parents and logistical or financial obstacles to transportation for tracing. COVID-19 movement restrictions and exposure fears also limited provider interactions for testing. Provider-implemented strategies included transport reimbursement, extensive counseling and alternative approaches to child testing for parents in sero-discordant relationships.ConclusionsFollowing intensified efforts around pediatric case finding, we found a high HIV positivity yield of 6.7% among previously undiagnosed children, with 81% of them aged ≥5 years. While elicitation improved over time, contact tracing for HIV testing remained the largest gap, missing opportunities to reach 17% of undiagnosed children. Ensuring adequate resources for tracing and HIV testing and supporting disclosure among couples, while emphasizing elicitation of ART clients' biological children can help to optimize pediatric case finding.

Project description:BACKGROUND:Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of "Advancing People of Color in Clinical Trials Now!" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE:This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS:ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS:We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS:ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. TRIAL REGISTRATION:ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17589.

Project description:IntroductionPregnancy induces significant physiological and cardiometabolic changes, and is associated with alterations in the maternal microbiota. Increasing rates of prepregnancy obesity, metabolic abnormalities and reduced physical activity, all impact negatively on the microbiota causing an imbalance between the commensal microorganisms (termed dysbiosis), which may drive complications, such as gestational diabetes or hypertensive disorders. Considerable work is needed to define the inter-relationships between the microbiome, nutrition, physical activity and pregnancy outcomes. The role of the microbiota during pregnancy remains unclear. The aim of the study is to define microbiota signatures longitudinally throughout pregnancy and the first year post birth, and to identify key clinical and environmental variables that shape the female microbiota profile during and following pregnancy.Methods and analysisThe Microbiome Understanding in Maternity Study (MUMS) is an Australian prospective longitudinal cohort study involving 100 mother-infant pairs. Women are enrolled in their first trimester and followed longitudinally. Assessment occurs at <13+0, 20+0-24+6 and 32+0-36+6 weeks gestation, birth and 6 weeks, 6 months and 12 months postpartum. At each assessment, self-collected oral, vaginal and faecal samples are collected with an additional postpartum skin swab and breastmilk sample. Each infant will have oral, faecal and skin swab samples collected. Measurements include anthropometrics, body composition, blood pressure, serum hormonal and metabolic parameters and vaginal pH. Dietary intake, physical activity and psychological state will be assessed using validated self-report questionnaires, and pregnancy and infant outcomes recorded. Parametric and non-parametric hypothesis tests will be used to test the association between high-risk and low-risk pregnancies and their outcomes.Ethics and disseminationThe study received the following approval: South Eastern Sydney Local Health District Research Ethics Committee (17/293 (HREC/17/POWH/605). Results will be made available to the participants of MUMS, their families and the funding bodies; in the form of a summary document. Results for the greater maternity care community and other researchers will be disseminated through conferences, local, national and international presentations and peer-reviewed publications.Trial registration numberACTRN12618000471280 (prospectively registered).

Project description:Introduction: Unexplained heterogeneity in outcomes following pediatric traumatic brain injury (TBI) is one of the most critical barriers to the development of effective prognostic tools and therapeutics. The addition of personal biological factors to our prediction models may account for a significant portion of unexplained variance and advance the field toward precision rehabilitation medicine. The overarching goal of the Epigenetic Effects on Pediatric Traumatic Brain Injury Recovery (EETR) study is to investigate an epigenetic biomarker involved in both childhood adversity and postinjury neuroplasticity to better understand heterogeneity in neurobehavioral outcomes following pediatric TBI. Our primary hypothesis is that childhood adversity will be associated with worse neurobehavioral recovery in part through an epigenetically mediated reduction in brain-derived neurotrophic factor (BDNF) expression in response to TBI. Methods and analysis: EETR is an observational, prospective, longitudinal concurrent cohort study of children aged 3-18 years with either TBI (n = 200) or orthopedic injury (n = 100), recruited from the UPMC Children's Hospital of Pittsburgh. Participants complete study visits acutely and at 6 and 12 months postinjury. Blood and saliva biosamples are collected at all time points-and cerebrospinal fluid (CSF) when available acutely-for epigenetic and proteomic analysis of BDNF. Additional measures assess injury characteristics, pre- and postinjury child neurobehavioral functioning, childhood adversity, and potential covariates/confounders. Recruitment began in July 2017 and will occur for ~6 years, with data collection complete by mid-2023. Analyses will characterize BDNF DNA methylation and protein levels over the recovery period and investigate this novel biomarker as a potential biological mechanism underlying the known association between childhood adversity and worse neurobehavioral outcomes following pediatric TBI. Ethics and dissemination: The study received ethics approval from the University of Pittsburgh Institutional Review Board. Participants and their parents provide informed consent/assent. Research findings will be disseminated via local and international conference presentations and manuscripts submitted to peer-reviewed journals. Trial Registration: The study is registered with clinicaltrials.org (ClinicalTrials.gov Identifier: NCT04186429).

Project description:IntroductionLittle is known about the effects of universal test and treat (UTT) policies on HIV care outcomes among youth living with HIV (YLHIV). Moreover, there is a paucity of information regarding when YLHIV are most susceptible to disengagement from care under the newest treatment guidelines. The longitudinal HIV care continuum is an underutilized tool that can provide a holistic understanding of population-level HIV care trajectories and be used to compare treatment outcomes across groups. We aimed to explore effects of the UTT policy on longitudinal outcomes among South African YLHIV and identify temporally precise opportunities for re-engaging this priority population in the UTT era.MethodsUsing medical record data, we conducted a retrospective cohort study among youth aged 18-24 diagnosed with HIV from August 2015-December 2018 in nine health care facilities in South Africa. We used Fine and Gray sub-distribution proportional hazards models to characterize longitudinal care continuum outcomes in the population overall and stratified by treatment era of diagnosis. We estimated the proportion of individuals in each stage of the continuum over time and the restricted mean time spent in each stage in the first year following diagnosis. Sub-group estimates were compared using differences.ResultsA total of 420 YLHIV were included. By day 365 following diagnosis, just 23% of individuals had no 90-or-more-day lapse in care and were virally suppressed. Those diagnosed in the UTT era spent less time as ART-naïve (mean difference=-19.3 days; 95% CI: -27.7, -10.9) and more time virally suppressed (mean difference = 17.7; 95% CI: 1.0, 34.4) compared to those diagnosed pre-UTT. Most individuals who were diagnosed in the UTT era and experienced a 90-or-more-day lapse in care disengaged between diagnosis and linkage to care or ART initiation and viral suppression.ConclusionsImplementation of UTT yielded modest improvements in time spent on ART and virally suppressed among South African YLHIV- however, meeting UNAIDS' 95-95-95 targets remains a challenge. Retention in care and re-engagement interventions that can be implemented between diagnosis and linkage to care and between ART initiation and viral suppression (e.g., longitudinal counseling) may be particularly important to improving care outcomes among South African YLHIV in the UTT era.

Dataset Information

Understanding and optimizing brain health in HIV now: protocol for a longitudinal cohort study with multiple randomized controlled trials.

Publications

Understanding and optimizing brain health in HIV now: protocol for a longitudinal cohort study with multiple randomized controlled trials.

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