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Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial

Ezeanolue, Echezona E; Obiefune, Michael C; Yang, Wei; Obaro, Stephen K; Ezeanolue, Chinenye O; Ogedegbe, Gbenga G
BACKGROUND:A total of 22 priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available prevention of mother-to-child HIV transmission (PMTCT) interventions. Finding new approaches to increase HIV testing among pregnant women is necessary to realize the WHO/ President's Emergency Plan for AIDS Relief (PEPFAR) goal of eliminating new pediatric infections by 2015. METHODS:This cluster randomized trial tests the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) versus a clinic-based approach on the rates of HIV testing and PMTCT completion among a cohort of church attending pregnant women. Recruitment occurs at the level of the churches and participants (in that order), while randomization occurs only at the church level. The trial is unblinded, and the churches are informed of their randomization group. Eligible participants, pregnant women attending study churches, are recruited during prayer sessions. HBI is delivered by trained community health nurses and church-based health advisors and provides free, integrated on-site laboratory tests (HIV plus hemoglobin, malaria, hepatitis B, sickle cell gene, syphilis) during a church-organized 'baby shower.' The baby shower includes refreshments, gifts exchange, and an educational game show testing participants' knowledge of healthy pregnancy habits in addition to HIV acquisition modes, and effective PMTCT interventions. Baby receptions provide a contact point for follow-up after delivery. This approach was designed to reduce barriers to screening including knowledge, access, cost and stigma. The primary aim is to evaluate the effect of HBI on the HIV testing rate among pregnant women. The secondary aims are to evaluate the effect of HBI on the rate of HIV testing among male partners of pregnant women and the rate of PMTCT completion among HIV-infected pregnant women. DISCUSSION/CONCLUSIONS:Results of this study will provide further understanding of the most effective strategies for increasing HIV testing among pregnant women in hard-to-reach communities. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov, NCT01795261.
PMCID:3700826
PMID: 23758933
ISSN: 1748-5908
CID: 3035432

Beyond medications and diet: alternative approaches to lowering blood pressure: a scientific statement from the american heart association

Brook, Robert D; Appel, Lawrence J; Rubenfire, Melvyn; Ogedegbe, Gbenga; Bisognano, John D; Elliott, William J; Fuchs, Flavio D; Hughes, Joel W; Lackland, Daniel T; Staffileno, Beth A; Townsend, Raymond R; Rajagopalan, Sanjay
Many antihypertensive medications and lifestyle changes are proven to reduce blood pressure. Over the past few decades, numerous additional modalities have been evaluated in regard to their potential blood pressure-lowering abilities. However, these nondietary, nondrug treatments, collectively called alternative approaches, have generally undergone fewer and less rigorous trials. This American Heart Association scientific statement aims to summarize the blood pressure-lowering efficacy of several alternative approaches and to provide a class of recommendation for their implementation in clinical practice based on the available level of evidence from the published literature. Among behavioral therapies, Transcendental Meditation (Class IIB, Level of Evidence B), other meditation techniques (Class III, Level of Evidence C), yoga (Class III, Level of Evidence C), other relaxation therapies (Class III, Level of Evidence B), and biofeedback approaches (Class IIB, Level of Evidence B) generally had modest, mixed, or no consistent evidence demonstrating their efficacy. Between the noninvasive procedures and devices evaluated, device-guided breathing (Class IIA, Level of Evidence B) had greater support than acupuncture (Class III, Level of Evidence B). Exercise-based regimens, including aerobic (Class I, Level of Evidence A), dynamic resistance (Class IIA, Level of Evidence B), and isometric handgrip (Class IIB, Level of Evidence C) modalities, had relatively stronger supporting evidence. It is the consensus of the writing group that it is reasonable for all individuals with blood pressure levels >120/80 mm Hg to consider trials of alternative approaches as adjuvant methods to help lower blood pressure when clinically appropriate. A suggested management algorithm is provided, along with recommendations for prioritizing the use of the individual approaches in clinical practice based on their level of evidence for blood pressure lowering, risk-to-benefit ratio, potential ancillary health benefits, and practicality in a real-world setting. Finally, recommendations for future research priorities are outlined.
PMID: 23608661
ISSN: 0194-911x
CID: 667462

The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH): From theory to clinical trial implementation

Boutin-Foster, Carla; Scott, Ebony; Rodriguez, Anna; Ramos, Rosio; Kanna, Balavenkatesh; Michelen, Walid; Charlson, Mary; Ogedegbe, Gbenga
This paper describes the application of a translational research model in developing The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH), a theoretically-based, randomized controlled trial. TRIUMPH targets blood pressure control among African-Americans with hypertension in a community health center and public hospital setting. TRIUMPH applies positive affect, self-affirmation, and motivational interviewing as strategies to increase medication adherence and blood pressure control. A total of 220 participants were recruited in TRIUMPH and are currently being followed. This paper provides a detailed description of the theoretical framework and study design of TRIUMPH and concludes with a critical reflection of the lessons learned in the process of implementing a health behavior intervention in a community-based setting. TRIUMPH provides a model for incorporating the translational science research paradigm to conducting pragmatic behavioral trials in a real-world setting in a vulnerable population. Lessons learned through interactions with our community partners reinforce the value of community engagement in research.
PMCID:4128940
PMID: 23403073
ISSN: 1551-7144
CID: 288092

Are there consequences of labeling patients with prehypertension? An experimental study of effects on blood pressure and quality of life

Spruill, Tanya M; Feltheimer, Seth D; Harlapur, Manjunath; Schwartz, Joseph E; Ogedegbe, Gbenga; Park, Youngjun; Gerin, William
OBJECTIVE: The prehypertension classification was introduced to facilitate prevention efforts among patients at increased risk for hypertension. Although patients who have been told that they have hypertension report worse outcomes than unaware hypertensives, little is known about whether or not prehypertension labeling has negative effects. We evaluated the effects of labeling individuals with prehypertension on blood pressure and health-related quality of life three months later. METHODS: One hundred adults (aged 19 to 82 [mean=40.0] years; 54% women; 64% racial/ethnic minorities) with screening blood pressure in the prehypertensive range (120-139/80-89mmHg) and no history of diagnosis or treatment of elevated blood pressure were randomly assigned to either a "Labeled" group in which they were informed of their prehypertension, or an "Unlabeled" group in which they were not informed. Subjects underwent office blood pressure measurement, 24-hour ambulatory blood pressure monitoring and completed self-report questionnaires at baseline and at three months. RESULTS: Multilevel mixed effects regression analyses indicated that changes in the white coat effect, office blood pressure, mean daytime ambulatory blood pressure, and physical and mental health did not differ significantly between the two groups. Adjusting for age, sex, race/ethnicity and body mass index did not affect the results. CONCLUSION: These findings suggest that labeling patients with prehypertension does not have negative effects on blood pressure or quality of life. Additional research is needed to develop approaches to communicating with patients about their blood pressure that will maximize the clinical and public health impact of the prehypertension classification.
PMCID:3631319
PMID: 23597332
ISSN: 0022-3999
CID: 304942

The Counseling Older Adults to Control Hypertension (COACH) trial: Design and methodology of a group-based lifestyle intervention for hypertensive minority older adults

Ogedegbe, Gbenga; Fernandez, Senaida; Fournier, Leanne; Silver, Stephanie A; Kong, Jian; Gallagher, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A
The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12months. The secondary outcomes are blood pressure control at 12months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination.
PMCID:3805359
PMID: 23462343
ISSN: 1551-7144
CID: 315932

Translating basic behavioral and social science research to clinical application: The EVOLVE mixed methods approach

Peterson, Janey C; Czajkowski, Susan; Charlson, Mary E; Link, Alissa R; Wells, Martin T; Isen, Alice M; Mancuso, Carol A; Allegrante, John P; Boutin-Foster, Carla; Ogedegbe, Gbenga; Jobe, Jared B
[Correction Notice: An Erratum for this article was reported in Vol 81(2) of Journal of Consulting and Clinical Psychology (see record 2012-29655-001). In the article a citation and reference were mistakenly omitted. Under the heading "Case Study: TBSRC," subheading "Positive affect," the first sentence should have read: "Positive affect (PA) is a mild feeling state induced by small events, such as receiving a small, unexpected gift, seeing a few minutes of comedy, or receiving a report of success on a small task (Ashby, Valentin, & Turken, 2002)." The corresponding reference is: Ashby, F., Valentin, V., & Turken, U. (2002). The effects of positive affect and arousal on working memory and executive attention: Neurobiology and computational models. In S. Moore & M. Oaksford (Eds.), Emotional Cognition: From Brain to Behaviour (pp. 245-287). Amsterdam: John Benjamins. All versions of this article have been corrected.] Objective: To describe a mixed-methods approach to develop and test a basic behavioral science-informed intervention to motivate behavior change in 3 high-risk clinical populations. Our theoretically derived intervention comprised a combination of positive affect and self-affirmation (PA/SA), which we applied to 3 clinical chronic disease populations. Method: We employed a sequential mixed methods model (EVOLVE) to design and test the PA/SA intervention in order to increase physical activity in people with coronary artery disease (post-percutaneous coronary intervention [PCI]) or asthma (ASM) and to improve medication adherence in African Americans with hypertension (HTN). In an initial qualitative phase, we explored participant values and beliefs. We next pilot tested and refined the intervention and then conducted 3 randomized controlled trials with parallel study design. Participants were randomized to combined PA/SA versus an informational control and were followed bimonthly for 12 months, assessing for health behaviors and interval medical events. Results: Over 4.5 years, we enrolled 1,056 participants. Changes were sequentially made to the intervention during the qualitative and pilot phases. The 3 randomized controlled trials enrolled 242 participants who had undergone PCI, 258 with ASM, and 256 with HTN (n = 756). Overall, 45.1% of PA/SA participants versus 33.6% of informational control participants achieved successful behavior change (p = .001). In multivariate analysis, PA/SA intervention remained a significant predictor of achieving behavior change (p < .002, odds ratio = 1.66), 95% CI [1.22, 2.27], controlling for baseline negative affect, comorbidity, gender, race/ethnicity, medical events, smoking, and age. Conclusions: The EVOLVE method is a means by which basic behavioral science research can be translated into efficacious interventions for chronic disease populations. (PsycINFO Database Record (c) 2013 APA, all rights reserved).
PMCID:3578179
PMID: 22963594
ISSN: 0022-006x
CID: 264112

Obstructive sleep apnea and cardiovascular disease in blacks: A call to action from the Association of Black Cardiologists

Olafiranye, Oladipupo; Akinboboye, Olakunle; Mitchell, Judith E; Ogedegbe, Gbenga; Jean-Louis, Girardin
Obstructive sleep apnea (OSA) has emerged as a new and important risk factor for cardiovascular disease (CVD). Over the last decade, epidemiologic and clinical research has consistently supported the association of OSA with increased cardiovascular (CV) morbidity and mortality. Such evidence prompted the American Heart Association to issue a scientific statement describing the need to recognize OSA as an important target for therapy in reducing CV risk. Emerging facts suggest that marked racial differences exist in the association of OSA with CVD. Although both conditions are more prevalent in blacks, almost all National Institutes of Health-funded research projects evaluating the relationship between OSA and CV risk have been conducted in predominantly white populations. There is an urgent need for research studies investigating the CV impact of OSA among high-risk minorities, especially blacks. This article first examines the evidence supporting the association between OSA and CVD and reviews the influence of ethnic/racial differences on this association. Public health implications of OSA and future directions, especially regarding minority populations, are discussed.
PMCID:4144432
PMID: 23537962
ISSN: 0002-8703
CID: 288102

Association of racial disparities in the prevalence of insulin resistance with racial disparities in vitamin D levels: National Health and Nutrition Examination Survey (2001-2006)

Williams, Stephen K; Fiscella, Kevin; Winters, Paul; Martins, David; Ogedegbe, Gbenga
We tested the hypothesis that racial differences in vitamin D levels are associated with racial disparities in insulin resistance between blacks and whites. Among 3628 non-Hispanic black and white adults in the National Health and Nutrition Examination Survey from 2001 to 2006, we examined the association between race and insulin resistance using the homeostasis assessment model for insulin resistance. We conducted analyses with and without serum 25-hydroxyvitamin D (25[OH]D). We adjusted for age, sex, educational level, body mass index, waist circumference, physical activity, alcohol intake, smoking, estimated glomerular filtration rate, and urinary albumin/creatinine ratio. Blacks had a lower mean serum 25(OH)D level compared with whites (14.6 [0.3] ng/mL vs 25.6 [0.4] ng/mL, respectively; P < .0001). Blacks had a higher odds ratio (OR) for insulin resistance without controlling for serum 25(OH)D levels (OR, 1.67; 95% confidence interval, 1.26-2.20). The association was not significant (OR, 1.28; 95% confidence interval, 0.90-1.82) after accounting for serum 25(OH)D levels. The higher burden of insulin resistance in blacks compared with whites may be partially mediated by the disparity in serum 25(OH)D levels.
PMCID:3649515
PMID: 23602243
ISSN: 0271-5317
CID: 348652

Heart Failure Associated Hospitalizations in the United States

Blecker, Saul; Paul, Margaret; Taksler, Glen; Ogedegbe, Gbenga; Katz, Stuart
OBJECTIVE: We sought to characterize temporal trends in hospitalizations with heart failure as a primary or secondary diagnosis. BACKGROUND: Heart failure patients are frequently admitted for both heart failure and other causes. METHODS: Using the Nationwide Inpatient Sample (NIS), we evaluated trends in heart failure hospitalizations between 2001 and 2009. Hospitalizations were categorized as either primary or secondary heart failure hospitalizations based the location of heart failure in the discharge diagnosis. National estimates were calculated using the sampling weights of the NIS. Age- and gender-standardized hospitalization rates were determined by dividing the number of hospitalizations by the United States population in a given year and using direct standardization. RESULTS: The number of primary heart failure hospitalizations in the United States decreased from 1,137,944 in 2001 to 1,086,685 in 2009, while secondary heart failure hospitalizations increased from 2,753,793 to 3,158,179 over the same period. Age- and gender-adjusted rates of primary heart failure hospitalizations decreased steadily over 2001-2009, from 566 to 468 per 100,000 people. Rates of secondary heart failure hospitalizations initially increased, from 1370 to 1476 per 100,000 from 2001-2006, then decreased to 1359 per 100,000 in 2009. Common primary diagnoses for secondary heart failure hospitalizations included pulmonary disease, renal failure, and infections. CONCLUSIONS: Although primary heart failure hospitalizations declined, rates of hospitalizations with a secondary diagnosis of heart failure were stable in the past decade. Strategies to reduce the high burden of hospitalizations of heart failure patients should include consideration of both cardiac disease and non-cardiac conditions.
PMCID:3838728
PMID: 23500328
ISSN: 0735-1097
CID: 254852

The Nigerian antihypertensive adherence trial: a community-based randomized trial

Adeyemo, Adebowale; Tayo, Bamidele O; Luke, Amy; Ogedegbe, Olugbenga; Durazo-Arvizu, Ramon; Cooper, Richard S
BACKGROUND:: Research in industrialized countries has demonstrated that a key factor limiting the control of hypertension is poor patient adherence and that the most successful interventions for long-term adherence employ multiple strategies. Very little data exist on this question in low-income countries, wherein medication-taking behavior may be less well developed. METHOD:: We conducted a treatment adherence trial of 544 patients [mean age approximately 63 years, mean blood pressure (BP) approximately 168/92 mmHg] with previously untreated hypertension in urban and rural Nigeria. Eligible participants were randomized to one of two arms: clinic management only, or clinic management and home visits. Both interventions included three elements: a community based, nurse-led treatment program with physician backup; facilitation of clinic visits and health education; and the use of diuretics and a beta blocker as needed. After initial diagnosis, the management protocol was implemented by a nurse with physician backup. Participants were evaluated monthly for 6 months. RESULTS:: Medication adherence was assessed with pill count and urine testing. Drop-out rates, by treatment group, ranged from 12 to 28%. Among participants who completed the 6-month trial, overall adherence was high ( approximately 77% of participants took >98% of prescribed pills). Adherence did not differ by treatment arm, but was better at the rural than the urban site and among those with higher baseline BP. Hypertension control (BP <140/90 mmHg) was achieved in approximately 66% of participants at 6 months. CONCLUSION:: This community-based intervention confirms relatively modest default rates compared with industrialized societies, and suggests that medication adherence can be high in developing world settings in clinic attenders.
PMCID:3530610
PMID: 23137954
ISSN: 0263-6352
CID: 210142