Publications by authors named "Yvonne Lewis"

18 Publications

  • Page 1 of 1

Pharmacokinetics and brain sigma 1 (σ1) receptor occupancy of MR309, a selective σ1 receptor antagonist.

Br J Clin Pharmacol 2021 Jun 22. Epub 2021 Jun 22.

Mundipharma Research Limited, Cambridge, UK.

Background And Purpose: Preclinical studies of MR309, a selective sigma1 receptor (σ1R) antagonist, support a potential role in treating neuropathic pain. We report two studies that provide insight into the pharmacokinetics (PK) and brain σ1R binding of MR309.

Experimental Approach: Steady-state PK of MR309 (400 mg QD and 200 mg BID for 10 days; EudraCT 2015-001818-99 [PK study]) and the relationship between MR309 plasma exposure and brain σ1R occupancy (EudraCT 2017-000670-11 [PET study]) were investigated in healthy volunteers. Positron emission tomography (PET) using the σ1R ligand [ C]SA4503 was conducted at baseline, 2h and 8h after a single dose of MR309 (200-800 mg). The relationship between brain σ1R occupancy and MR309 exposure was explored using data-driven model fitting.

Key Results: MR309 was well tolerated, brain σ1R occupancy ranged between 30.5% and 74.9% following single-dose MR309 (n=7). MR309 BID provided a plasma PK profile with less fluctuation than QD dosing (n=16). MR309 200 mg BID yielded average steady state plasma concentrations between 2000 and 4000 ng/mL in the PK study, which corresponded to an estimated brain σ1R occupancy of 59-74%.

Conclusions And Implications: MR309 200 mg BID dose was below the 75% σ1R occupancy threshold expected to elicit maximal antinociceptive effect as observed in neuropathic pain models. Further investigations of MR309 for neuropathic pain will require higher brain σ1R occupancy, and establish the optimal dose by elucidating the clinical impact of a broad range of brain σ1R occupancy across different neuropathic pain indications.
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http://dx.doi.org/10.1111/bcp.14952DOI Listing
June 2021

Test-retest variability and reference region-based quantification of F-BCPP-EF for imaging mitochondrial complex I in the human brain.

J Cereb Blood Flow Metab 2021 04 5;41(4):771-779. Epub 2020 Jun 5.

Invicro LLC, Boston, MA, USA.

Mitochondrial complex I (MC-I) is an essential regulator of brain bioenergetics and can be quantified in the brain using PET radioligand F-BCPP-EF. Here we evaluate the test-retest reproducibility of F-BCPP-EF in humans, and assess the use of a non-invasive quantification method (standardised uptake value ratio - SUVR). Thirty healthy volunteers had a 90-min dynamic F-BCPP-EF scan with arterial blood sampling, five of which received a second scan to be included in the test-retest analysis. Time-activity curves (TAC) were analysed using multilinear analysis 1 (MA1) and the two-tissue compartment model (2TC) to estimate volumes of distribution (V). Regional SUVR-1 values were calculated from the 70 to 90-min TAC data using the centrum semiovale as a pseudo reference region, and compared to kinetic analysis-derived outcome measures. The mean absolute test-retest variability of V ranged from 12% to 18% across regions. Both DVR-1and SUVR-1 had improved test-retest variability in the range 2%-7%. SUVR-1 was highly correlated with DVR-1 (r = 0.97,  = 30). In conclusion, F-BCPP-EF has suitable test-retest reproducibility and can be used to quantify MC-I in clinical studies.
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http://dx.doi.org/10.1177/0271678X20928149DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983506PMC
April 2021

The Continuum of Community Engagement in Research: A Roadmap for Understanding and Assessing Progress.

Prog Community Health Partnersh 2019 ;13(4):427-434

Background: The past two decades have been marked by increased community involvement in the research process. Community-engaged research (CEnR) is increasingly promoted in the literature, and academic programs with a community-academic partnership focus. Community-based participatory research (CBPR) is an approach to frame equitable community involvement in research and is a critical component of the CEnR continuum. As with CEnR, noted benefits of using CBPR expressed in the literature, which include enhancing the relevance and application of the research data, expertise to complex problems at all stages of research, overcoming community distrust, and improving community health. This article presents a community engagement (CE) model that includes seven defined designations for CEnR. In addition, this model includes equity indicators and contextual factors for consideration at the various levels of engagement along the continuum.

Methods: The CE model described in this article combines the principles of CE and CBPR in conjunction with a continuum model. The continuum integrates a focus on health equity and contextual factors providing perspectives from both community and academic partners at each point of engagement.

Conclusions: A broadly defined CEnR continuum will allow researchers, community members and organizations to readily identify 1) where they are on the continuum of CEnR, 2) appropriate access points to enter the continuum based on existing contextual factors, and 3) actions to promote progression on the continuum. Funders have the opportunity to specify the appropriate level of CE needed to accomplish the goals of their identified priorities.
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http://dx.doi.org/10.1353/cpr.2019.0064DOI Listing
August 2020

Serotonin release measured in the human brain: a PET study with [C]CIMBI-36 and d-amphetamine challenge.

Neuropsychopharmacology 2020 04 12;45(5):804-810. Epub 2019 Nov 12.

Department of Clinical Neuroscience and Neuroimaging, Brighton and Sussex Medical School, University of Sussex, Brighton, BN1 9QU, UK.

Positron emission tomography (PET) enables non-invasive estimation of neurotransmitter fluctuations in the living human brain. While these methods have been applied to dopamine and some other transmitters, estimation of 5-hydroxytryptamine (5-HT; Serotonin) release has proved to be challenging. Here we demonstrate the utility of the novel 5-HT2A receptor agonist radioligand, [C]CIMBI-36, and a d-amphetamine challenge to evaluate synaptic 5-HT changes in the living human brain. Seventeen healthy male volunteers received [C]CIMBI-36 PET scans before and 3 h after an oral dose of d-amphetamine (0.5 mg/kg). Dynamic PET data were acquired over 90 min, and the total volume of distribution (V) in the frontal cortex and the cerebellum derived from a kinetic analysis using MA1. The frontal cortex binding potential (BP) was calculated as (V/V) - 1. ∆BP = 1 - (BP post-dose/BP baseline) was used as an index of 5-HT release. Statistical inference was tested by means of a paired Students t-test evaluating a reduction in post-amphetamine [C]CIMBI-36 BP. Following d-amphetamine administration, [C]CIMBI-36 BP was reduced by 14 ± 13% (p = 0.002). Similar effects were observed in other cortical regions examined in an exploratory analysis. [C]CIMBI-36 binding is sensitive to synaptic serotonin release in the human brain, and when combined with a d-amphetamine challenge, the evaluation of the human brain serotonin system in neuropsychiatric disorders, such as major depression and Parkinson's disease is enabled.
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http://dx.doi.org/10.1038/s41386-019-0567-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7075951PMC
April 2020

Characterization of 3 PET Tracers for Quantification of Mitochondrial and Synaptic Function in Healthy Human Brain: F-BCPP-EF, C-SA-4503, and C-UCB-J.

J Nucl Med 2020 01 19;61(1):96-103. Epub 2019 Jul 19.

Hamamatsu Photonics, Hamamatsu City, Shizuoka, Japan.

Mitochondrial complex 1 is involved in maintaining brain bioenergetics; σ-1 receptor responds to neuronal stress; and synaptic vesicle protein 2A reflects synaptic integrity. Expression of each of these proteins is altered in neurodegenerative diseases. Here, we characterize the kinetic behavior of 3 PET radioligands-F-BCPP-EF, C-SA-4503, and C-UCB-J-for the measurement of mitochondrial complex 1, σ-1 receptor, and synaptic vesicle protein 2A, respectively, and determine appropriate analysis workflows for their application in future studies of the in vivo molecular pathology of these diseases. Twelve human subjects underwent dynamic PET scans with each radioligand, including associated arterial blood sampling. A range of kinetic models was investigated to identify an optimal kinetic analysis method for each radioligand and a suitable acquisition duration. All 3 radioligands readily entered the brain and yielded heterogeneous uptake consistent with the known distribution of the targets. The optimal models determined for the regional estimates of volume of distribution were multilinear analysis 1 (MA1) and the 2-tissue-compartment model for F-BCPP-EF, MA1 for C-SA-4503, and both MA1 and the 1-tissue-compartment model for C-UCB-J. Acquisition times of 70, 80, and 60 min for F-BCPP-EF, C-SA-4503, C-UCB-J, respectively, provided good estimates of regional volume of distribution values. An effect of age was observed on F-BCPP-EF and C-UCB-J signal in the caudate. These ligands can be assessed for their potential to stratify patients or monitor the progression of molecular neuropathology in neurodegenerative diseases.
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http://dx.doi.org/10.2967/jnumed.119.228080DOI Listing
January 2020

The Church Challenge: A community-based multilevel cluster randomized controlled trial to improve blood pressure and wellness in African American churches in Flint, Michigan.

Contemp Clin Trials Commun 2019 Jun 2;14:100329. Epub 2019 Feb 2.

Division of Public Health, College of Human Medicine, Michigan State University, 200 E 1st St, Flint, MI, 48502, USA.

Chronic disease carries high morbidity and mortality in the United States, with large racial and ethnic disparities observed in chronic disease. Physical activity and healthy food are vital for chronic disease prevention yet challenging to access in economically distressed areas. Public health prevention efforts have become particularly prominent within faith-based organizations over the last three decades. This manuscript describes the protocol of the Church Challenge, a multilevel cluster-randomized controlled nutrition and physical activity trial across 24 churches to reduce blood pressure by 6 mmHg among 576 residents in Flint, MI. The Church Challenge was developed using community-based participatory approaches and is rooted in a church-based program developed by and for primarily African-American Flint church congregations. This three-level intervention addresses health at the community (level 3), church (level 2), and individual (level 1) to reduce blood pressure, reduce chronic disease risk, and promote health equity and wellbeing in Flint. Churches are randomized in a 1:1 ratio to a 16-week physical activity and nutrition program or a 4-session health and wellness workshop. Flint is not a unique community but has a history of traumatic community wide events; even now, the public health infrastructure continues to be a challenge and distract residents from focusing on their health. This trial is highly significant and innovative because it uses a combination of evidence-based practices simultaneously supporting health behavior change for individuals and their faith organizations, and evaluates multilevel efforts to sustain long-term health promotion activities in vulnerable communities like Flint.
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http://dx.doi.org/10.1016/j.conctc.2019.100329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402374PMC
June 2019

Sustainable community engagement in a constantly changing health system.

Learn Health Syst 2018 Jul 12;2(3). Epub 2018 Mar 12.

Healthy Flint Research Coordinating Center.

Engaging patients and communities is invaluable for achieving a patient-centered learning health system. Based on lessons learned in genomic and public health public engagement efforts of our community based organizations in Flint, Michigan, we offer a continuum model for distinguishing various levels of community engagement and recommendations for approaching community, patient and public engagement for healthcare systems that are expanding uses of health information.
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http://dx.doi.org/10.1002/lrh2.10053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6054482PMC
July 2018

A study of the focal adhesion kinase inhibitor GSK2256098 in patients with recurrent glioblastoma with evaluation of tumor penetration of [11C]GSK2256098.

Neuro Oncol 2018 11;20(12):1634-1642

NIHR UCLH Clinical Research Facility, University College London Hospitals NHS Foundation Trust, London, UK.

Background: GSK2256098 is a novel oral focal adhesion kinase (FAK) inhibitor. Preclinical studies demonstrate growth inhibition in glioblastoma cell lines. However, rodent studies indicate limited blood-brain barrier (BBB) penetration. In this expansion cohort within a phase I study, the safety, tolerability, pharmacokinetics (PK), and clinical activity of GSK2256098 were evaluated in patients with recurrent glioblastoma. Biodistribution and kinetics of [11C]GSK2256098 were assessed in a substudy using positron-emission tomography (PET).

Methods: Patients were treated with GSK2256098 until disease progression or withdrawal due to adverse events (AEs). Serial PK samples were collected on day 1. On a single day between days 9 and 20, patients received a microdose of intravenous [11C]GSK2256098 and were scanned with PET over 90 minutes with parallel PK sample collection. Response was assessed by MRI every 6 weeks.

Results: Thirteen patients were treated in 3 dose cohorts (1000 mg, 750 mg, 500 mg; all dosed twice daily). The maximum tolerated dose was 1000 mg twice daily. Dose-limiting toxicities were related to cerebral edema. Treatment-related AEs (>25%) were diarrhea, fatigue, and nausea. Eight patients participated in the PET substudy, with [11C]GSK2256098 VT (volume of distribution) estimates of 0.9 in tumor tissue, 0.5 in surrounding T2 enhancing areas, and 0.4 in normal brain. Best response of stable disease was observed in 3 patients, including 1 patient on treatment for 11.3 months.

Conclusions: GSK2256098 was tolerable in patients with relapsed glioblastoma. GSK2256098 crossed the BBB at low levels into normal brain, but at markedly higher levels into tumor, consistent with tumor-associated BBB disruption. Additional clinical trials of GSK2256098 are ongoing.
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http://dx.doi.org/10.1093/neuonc/noy078DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231205PMC
November 2018

Investigation of the Brain Biodistribution of the Lipoprotein-Associated Phospholipase A (Lp-PLA) Inhibitor [F]GSK2647544 in Healthy Male Subjects.

Mol Imaging Biol 2017 02;19(1):153-161

GlaxoSmithKline, Neurosciences, Clinical Unit Cambridge, Addenbrooke's Hospital, Cambridge, CB2 0GG, UK.

Purpose: GSK2647544 is a potent and specific inhibitor of lipoprotein-associated phospholipase A (Lp-PLA), which was in development as a potential treatment for Alzheimer's disease (AD). In order to refine therapeutic dose predictions and confirm brain penetration, a radiolabelled form of the inhibitor, [F]GSK2647544, was manufactured for use in a positron emission tomography (PET) biodistribution study.

Procedures: [F]GSK2647544 was produced using a novel, copper iodide (Cu(I)) mediated, [F]trifluoromethylation methodology. Healthy male subjects (n = 4, age range 34-42) received an oral dose of unlabelled GSK2647544 (100 mg) and after 2 h an intravenous (iv) injection of [F]GSK2647544 (average injected activity and mass were 106 ± 47 MBq and 179 ± 55 μg, respectively) followed by dynamic PET scans for 120 min. Defined regions of interest (ROI) throughout the brain were used to obtain regional time-activity curves (TACs) and compartmental modelling analysis used to estimate the primary outcome measure, whole brain volume of distribution (V). Secondary PK and safety endpoints were also recorded.

Results: PET dynamic data were successfully obtained from all four subjects and there were no clinically significant variations of the safety endpoints. Inspection of the TACs indicated a relatively homogenous uptake of [F]GSK2647544 across all the ROIs examined. The mean whole brain V was 0.56 (95 % CI, 0.41-0.72). Secondary PK parameters, C (geometric mean) and T (median), were 354 ng/ml and 1.4 h, respectively. Metabolism of GSK2647544 was relatively consistent across subjects, with 20-40 % of the parent compound [F]GSK2647544 present after 120 min.

Conclusions: The study provides evidence that GSK2647544 is able to cross the blood brain barrier in healthy male subjects leading to a measurable brain exposure. The administered doses of GSK2647544 were well tolerated. Exploratory modelling suggested that a twice-daily dose of 102 mg, at steady state, would provide ~80 % trough inhibition of brain Lp-PLA activity.

Trial Registration: Clintrials.gov: NCT01924858.
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http://dx.doi.org/10.1007/s11307-016-0982-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5209404PMC
February 2017

Determination of [(11)C]PBR28 binding potential in vivo: a first human TSPO blocking study.

J Cereb Blood Flow Metab 2014 Jun 19;34(6):989-94. Epub 2014 Mar 19.

1] Centre for Neuroimaging Sciences, Institute of Psychiatry, King's College London, London, UK [2] Imanova, Centre for Imaging Sciences, London, UK.

Positron emission tomography (PET) targeting the 18 kDa translocator protein (TSPO) is used to quantify neuroinflammation. Translocator protein is expressed throughout the brain, and therefore a classical reference region approach cannot be used to estimate binding potential (BPND). Here, we used blockade of the TSPO radioligand [(11)C]PBR28 with the TSPO ligand XBD173, to determine the non-displaceable volume of distribution (VND), and hence estimate the BPND. A total of 26 healthy volunteers, 16 high-affinity binders (HABs) and 10 mixed affinity binders (MABs) underwent a [(11)C]PBR28 PET scan with arterial sampling. Six of the HABs received oral XBD173 (10 to 90 mg), 2 hours before a repeat scan. In XBD173-dosed subjects, VND was estimated via the occupancy plot. Values of BPND for all subjects were calculated using this VND estimate. Total volume of distribution (VT) of MABs (2.94±0.31) was lower than VT of HABs (4.33±0.29) (P<0.005). There was dose-dependent occupancy of TSPO by XBD173 (ED50=0.34±0.13 mg/kg). The occupancy plot provided a VND estimate of 1.98 (1.69, 2.26). Based on these VND estimates, BPND for HABs is approximately twice that of MABs, consistent with predictions from in vitro data. Our estimates of [(11)C]PBR28 VND and hence BPND in the healthy human brain are consistent with in vitro predictions. XBD173 blockade provides a practical means of estimating VND for TSPO targeting radioligands.
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http://dx.doi.org/10.1038/jcbfm.2014.46DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4050243PMC
June 2014

Racism, health status, and birth outcomes: results of a participatory community-based intervention and health survey.

J Urban Health 2011 Feb;88(1):84-97

Prevention Research Center of Michigan, University of Michigan School of Public Health, Ann Arbor, MI, USA.

Many community-based participatory research (CBPR) partnerships address social determinants of health as a central consideration. However, research studies that explicitly address racism are scarce in the CBPR literature, and there is a dearth of available community-generated data to empirically examine how racism influences health disparities at the local level. In this paper, we provide results of a cross-sectional, population-based health survey conducted in the urban areas of Genesee and Saginaw Counties in Michigan to assess how a sustained community intervention to reduce racism and infant mortality influenced knowledge, beliefs, and experiences of racism and to explore how perceived racism is associated with self-rated health and birth outcomes. We used ANOVA and regression models to compare the responses of intervention participants and non-participants as well as African Americans and European Americans (N = 629). We found that intervention participants reported greater acknowledgment of the enduring and differential impact of racism in comparison to the non-intervention participants. Moreover, survey analyses revealed that racism was associated with health in the following ways: (1) experiences of racial discrimination predicted self-rated physical health, mental health, and smoking status; (2) perceived racism against one's racial group predicted lower self-rated physical health; and (3) emotional responses to racism-related experiences were marginally associated with lower birth-weight births in the study sample. Our study bolsters the published findings on perceived racism and health outcomes and highlights the usefulness of CBPR and community surveys to empirically investigate racism as a social determinant of health.
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http://dx.doi.org/10.1007/s11524-010-9530-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3042077PMC
February 2011

Integrating women's human rights into global health research: an action framework.

J Womens Health (Larchmt) 2010 Nov 25;19(11):2091-9. Epub 2010 Oct 25.

Center for Research on Women and Gender, University of Illinois at Chicago, Chicago, Illinois 60608, USA.

This article uses Scale of Change theory as a framework to guide global health researchers to synergistically target women's health outcomes in the context of improving their right to freedom, equity, and equality of opportunities. We hypothesize that health researchers can do so through six action strategies. These strategies include (1) becoming fully informed of women's human rights directives to integrate them into research, (2) mainstreaming gender in the research, (3) using the expertise of grass roots women's organizations in the setting, (4) showcasing women's equity and equality in the organizational infrastructure, (5) disseminating research findings to policymakers in the study locale to influence health priorities, and (6) publicizing the social conditions that are linked to women's diseases. We explore conceptual and logistical dilemmas in transforming a study using these principles and also provide a case study of obstetric fistula reduction in Nigeria to illustrate how these strategies can be operationalized. Our intent is to offer a feasible approach to health researchers who, conceptually, may link women's health to social and cultural conditions but are looking for practical implementation strategies to examine a women's health issue through the lens of their human rights.
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http://dx.doi.org/10.1089/jwh.2010.2119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3004131PMC
November 2010

Community-based organizational capacity building as a strategy to reduce racial health disparities.

J Prim Prev 2010 Apr;31(1-2):31-9

Department of Health Behavior & Health Education, School of Public Health, University of Michigan, 1415 Washington Heights, 3806 SPH I, Ann Arbor, MI 48109-2029, USA.

One of the biggest challenges facing racial health disparities research is identifying how and where to implement effective, sustainable interventions. Community-based organizations (CBOs) and community-academic partnerships are frequently utilized as vehicles to conduct community health promotion interventions without attending to the viability and sustainability of CBOs or capacity inequities among partners. Utilizing organizational empowerment theory, this paper describes an intervention designed to increase the capacity of CBOs and community-academic partnerships to implement strategies to improve community health. The Capacity Building project illustrates how capacity building interventions can help to identify community health needs, promote community empowerment, and reduce health disparities.
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http://dx.doi.org/10.1007/s10935-010-0202-zDOI Listing
April 2010

Mapping a message for faith leaders: encouraging community health promotion with local health data.

Health Promot Pract 2010 Nov 24;11(6):837-44. Epub 2009 Jan 24.

Prevention Research Center of Michigan, University of Michigan, Ann Arbor, MI 48109, USA.

This study reports the use of a community-based health survey to share local health information with faith leaders. Geographical information systems software identified survey respondents within 2 km (1.25 miles) of places of worship. Results were tabulated for the community surrounding each place of worship and were compared with city- and county-level data. Faith leaders were presented with community-specific reports describing the health attributes of residents who lived in the surrounding area, in order to assist with the identification issues of concern and opportunities to develop health ministries to address these issues. Faith leaders were encouraged to share this information with members of their faith community and develop means of obtaining additional information on the people of interest. We believe that engaging faith leaders with neighborhood-specific health information will be critical in providing an understanding of the importance of their voice in improving health outcomes of their faith community, the surrounding neighborhood, and the community at large. Our goal is to empower faith leaders to understand personal and community health issues and to act as a conduit for health-related information and health promotion at a local level. Church health teams developed an HIV and sexually transmitted infection prevention program for African American adolescents and young adults.
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http://dx.doi.org/10.1177/1524839908328995DOI Listing
November 2010

Community engagement in Prevention Research: The Centers for Disease Control and Prevention's Prevention Research Centers' National Community Committee.

Prog Community Health Partnersh 2009 ;3(1):73-81

Center for Disease Control and Prevention, GA, USA.

The Prevention Research Centers (PRC) Program of the Centers for Disease Control and Prevention (CDC) supports prevention research using community-based participatory research (CBPR) and other community engagement approaches. This paper describes the development of the PRC's National Community Committee (NCC), how the committee strengthened the national program's commitment to CBPR, the impact the committee's activities have had on national initiatives, and the lessons learned from supporting a national community approach in a prevention research program. Community representatives from each PRC's community committee were invited to share and exchange resources, knowledge, and skills to guide the national program. As a result, the NCC was developed. By embracing diversity, building capacity among members, and offering co-learning opportunities, the NCC helped to strengthen the practice of CBPR. The committee's activities helped to ensure community participation at the program's national level and led to involvement in other prevention research initiatives external to the PRC program. Program and committee leaders maintained a shared vision and increased community members' skills. The PRC NCC has taken the concept of community partnership to a national level and has changed the way some community members understand their role in research.
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http://dx.doi.org/10.1353/cpr.0.0047DOI Listing
January 2011

Translating recommendations into reality: community voices.

Prev Chronic Dis 2007 Jul 15;4(3):A45. Epub 2007 Jun 15.

YMCA of the USA, 1101 17th St NW, Ste 705, Washington, DC 20036, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1955405PMC
July 2007

A birth records analysis of the Maternal Infant Health Advocate Service program: a paraprofessional intervention aimed at addressing infant mortality in African Americans.

Ethn Dis 2004 ;14(3 Suppl 1):S102-7

University of Michigan, School of Public Health/Genesee County Health Department, Flint, Michigan 48502, USA.

Recognizing that no single intervention was likely to eliminate racial disparities, the Genesee County REACH 2010 partnership, utilizing both "bench" science and "trench" knowledge, developed 13 broad-based, multi-faceted interventions to eliminate infant mortality. This article provides highlights from a recent birth records comparison analysis of the Maternal Infant Health Advocate Service (MIHAS) intervention, and is solely based on the records of 111 MIHAS clients, and a random sample of 350 African-American women residing in Flint, Michigan. The MIHAS clients were more likely than the comparison sample not to have graduated from high school (56% vs 35%, respectively, P<.0001). The MIHAS clients were more likely to report at least some smoking during pregnancy (20% vs 15%, respectively, P<.05). However, after controlling for age and education, these results were no longer statistically significant. In terms of birth outcomes, the comparative odds of MIHAS clients delivering a low birth-weight infant are 1.124 (95% CI: 0.620-2.038); the odds of their delivering an infant at 37 weeks or earlier are 1.032 (0.609-1.749). Although the MIHAS clients did not have statistically better birth outcomes than those of the general African-American population in Flint, the MIHAS clients did not demonstrate the outcomes one would expect, given their higher level of risk. Based on this analysis, the MIHAS intervention may have brought its clients "up to par" with the general community on several birth outcomes.
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December 2005
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