Faculty Bibliography

BACKGROUND: Few effective community-based interventions exist to increase HIV testing and uptake of antiretroviral therapy (ART) in pregnant women in hard-to-reach resource-limited settings. We assessed whether delivery of an intervention through churches, the Healthy Beginning Initiative, would increase uptake of HIV testing in pregnant women compared with standard health facility referral. METHODS: In this cluster randomised trial, we enrolled self-identified pregnant women aged 18 years and older who attended churches in southeast Nigeria. We randomised churches (clusters) to intervention or control groups, stratified by mean annual number of infant baptisms (<80 vs >/=80). The Healthy Beginning Initiative intervention included health education and on-site laboratory testing implemented during baby showers in intervention group churches, whereas participants in control group churches were referred to health facilities as standard. Participants and investigators were aware of church allocation. The primary outcome was confirmed HIV testing. This trial is registered with ClinicalTrials.gov, identifier number NCT 01795261. FINDINGS: Between Jan 20, 2013, and Aug 31, 2014, we enrolled 3002 participants at 40 churches (20 per group). 1309 (79%) of 1647 women attended antenatal care in the intervention group compared with 1080 (80%) of 1355 in the control group. 1514 women (92%) in the intervention group had an HIV test compared with 740 (55%) controls (adjusted odds ratio 11.2, 95% CI 8.77-14.25; p<0.0001). INTERPRETATION: Culturally adapted, community-based programmes such as the Healthy Beginning Initiative can be effective in increasing HIV screening in pregnant women in resource-limited settings. FUNDING: US National Institutes of Health and US President's Emergency Plan for AIDS Relief.

INTRODUCTION: Self-monitoring of blood pressure is effective in reducing blood pressure in hypertension. However previous meta-analyses have shown a considerable amount of heterogeneity between studies, only part of which can be accounted for by meta-regression. This may be due to differences in design, recruited populations, intervention components or results among patient subgroups. To further investigate these differences, an individual patient data (IPD) meta-analysis of self-monitoring of blood pressure will be performed. METHODS AND ANALYSIS: We will identify randomised trials that have compared patients with hypertension who are self-monitoring blood pressure with those who are not and invite trialists to provide IPD including clinic and/or ambulatory systolic and diastolic blood pressure at baseline and all follow-up points where both intervention and control groups were measured. Other data requested will include measurement methodology, length of follow-up, cointerventions, baseline demographic (age, gender) and psychosocial factors (deprivation, quality of life), setting, intensity of self-monitoring, self-monitored blood pressure, comorbidities, lifestyle factors (weight, smoking) and presence or not of antihypertensive treatment. Data on all available patients will be included in order to take an intention-to-treat approach. A two-stage procedure for IPD meta-analysis, stratified by trial and taking into account age, sex, diabetes and baseline systolic BP will be used. Exploratory subgroup analyses will further investigate non-linear relationships between the prespecified variables. Sensitivity analyses will assess the impact of trials which have and have not provided IPD. ETHICS AND DISSEMINATION: This study does not include identifiable data. Results will be disseminated in a peer-reviewed publication and by international conference presentations. CONCLUSIONS: IPD analysis should help the understanding of which self-monitoring interventions for which patient groups are most effective in the control of blood pressure.

BACKGROUND: Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR. DISCUSSION: Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system.

BACKGROUND: Clinical trial evidence suggests poorer outcomes in blacks compared with whites when treated with an angiotensin-converting enzyme (ACE) inhibitor-based regimen, but this has not been evaluated in clinical practice. OBJECTIVES: This study evaluated the comparative effectiveness of an ACE inhibitor-based regimen on a composite outcome of all-cause mortality, stroke, and acute myocardial infarction (AMI) in hypertensive blacks compared with whites. METHODS: We conducted a retrospective cohort study of 434,646 patients in a municipal health care system. Four exposure groups (Black-ACE, Black-NoACE, White-ACE, White-NoACE) were created based on race and treatment exposure (ACE or NoACE). Risk of the composite outcome and its components was compared across treatment groups and race using weighted Cox proportional hazard models. RESULTS: Our analysis included 59,316 new users of ACE inhibitors, 47% of whom were black. Baseline characteristics were comparable for all groups after inverse probability weighting adjustment. For the composite outcome, the race treatment interaction was significant (p = 0.04); ACE use in blacks was associated with poorer cardiovascular outcomes (ACE vs. NoACE: 8.69% vs. 7.74%; p = 0.05) but not in whites (6.40% vs. 6.74%; p = 0.37). Similarly, the Black-ACE group had higher rates of AMI (0.46% vs. 0.26%; p = 0.04), stroke (2.43% vs. 1.93%; p = 0.05), and congestive heart failure (3.75% vs. 2.25%; p < 0.0001) than the Black-NoACE group. However, the Black-ACE group was no more likely to develop adverse effects than the White-ACE group. CONCLUSIONS: ACE inhibitor-based therapy was associated with poorer cardiovascular outcomes in hypertensive blacks but not in whites. These findings confirm clinical trial evidence that hypertensive blacks have poorer outcomes than whites when treated with an ACE inhibitor-based regimen.

Cardiovascular disease (CVD) is a major contributor to the growing public health epidemic in chronic diseases. Much of the disease and disability burden from CVDs are in people younger than the age of 70 years in low- and middle-income countries, formerly "the developing world." The risk of CVD is heavily influenced by environmental conditions and lifestyle variables. In this article we review the scope of the CVD problem in low- and middle-income countries, including economic factors, risk factors, at-risk groups, and explanatory frameworks that hypothesize the multifactorial drivers. Finally, we discuss current and potential interventions to reduce the burden of CVD in vulnerable populations including research needed to evaluate and implement promising solutions for those most at risk.

BACKGROUND: Human papillomavirus (HPV) has not been studied among homeless women in the United States. We assessed knowledge and attitudes regarding HPV infection and the HPV vaccine among homeless women. METHODS: We enrolled 300 homeless women age 19 to 65 residing in multiple New York City shelters from 2012 to 2014. We used a national survey to collect HPV data. RESULTS: Mean age was 44.7 +/- 12.16 years. The majority were Black, heterosexual, and single; 50.6% were smokers. Almost all HPV knowledge and attitudes data were considerably below the national averages; 41.9% never heard of HPV. Only 36.5% knew that HPV is a sexually transmitted disease; 41.5% knew that HPV causes cervical cancer; and only 19.5% and 17.3% received provider counseling regarding HPV testing and vaccine, respectively. Among participants, 65.4% reported that they would vaccinate their eligible daughters for HPV. Lower rates of up-to-date Pap tests were associated with a lack of knowledge regarding relationship between HPV and abnormal Pap test (p < .01). CONCLUSIONS: We recommend improved HPV counseling by providers during any clinical encounter to reduce missed opportunities, coupled with employing patient teaching coach or navigators to improve health literacy and to connect patients to services regarding HPV and cervical cancer.

PURPOSE: Millions of homeless Americans have lower cancer screening and higher cancer mortality rates. We explored perspectives and perceptions regarding cancer and cancer screening among homeless. METHODS: Using random and criteria sampling, we conducted in-depth semi-structured interviews with 50 homeless adults from New York City's (NYC) shelters and shelter-based clinics. RESULTS: Mean age was 51.66 years with average 2.03 years of homelessness; 33/50 were older than 50. Only a small number of participants had their recommended cancer screening. Contrary to general assumptions and despite significant barriers, the homeless were concerned about cancer, believed their risk of cancer is higher compared to the general population, and generally considered screening a high priority during homelessness. While they acknowledged several individual- and systems-level barriers, they welcomed targeted measures to address their multi-level barriers. Suggested strategies included active counseling by providers, health education or reminders via mHealth strategies or face-to-face in shelters, addressing potential providers' prejudice and biases regarding their priorities, incentives, and patient navigators or coach to help navigating the complex cancer screening process. CONCLUSIONS: There are gaps in effective cancer screening despite adequate attitude and perceptions among homeless. The health system needs to shift from addressing only basic care to a more equitable approach with accessible and acceptable opportunities for preventive cancer care for the homeless.

INTRODUCTION: In sub-Saharan Africa (SSA), an estimated 74.7 million individuals are hypertensive. Reducing the growing burden of hypertension in sub-Saharan Africa will require a variety of strategies one of which is identifying the extent to which actions originating at the health systems level improves optimal management and control. METHODS AND RESULTS: We conducted a narrative synthesis of available papers examining health systems factors influencing optimal hypertension in SSA. Eligible studies included those that analyzed the impact of health systems on hypertension awareness, treatment, control and medication adherence. Twenty-five articles met the inclusion criteria and the narrative synthesis identified the following themes: 1) how physical resources influence mechanisms supportive of optimal hypertension control; 2) the role of human resources with enabling and/or inhibiting hypertension control goals; 3) the availability and/or use of intellectual resources; 4) how health systems financing facilitate and/or compromise access to products necessary for optimal hypertension control. CONCLUSION: The findings highlight the need for further research on the health systems factors that influence management and control of hypertension in the region.

BACKGROUND: Among US medical schools, demand for Global Health (GH) programs continues to grow. At the same time, cultural competency training has become a priority for medical students who will care for an increasingly diverse US patient population. We describe a pilot period for a new GH Selective designed to introduce medical students to global medicine and enhance culturally-sensitive communication skills. METHODS: As a 4-week clinical clerkship, the GH Selective was offered annually over a three-year period to a total of 33 students. Activities included clinical assignments, cultural competency and clinical skills simulations, patient case discussions in tropical medicine, journal clubs, and lectures. Faculty assessments of student performance and student evaluations of course content were focused on 6 course objectives, adapted from standardized GH objectives. RESULTS: For each offering of the GH Selective, at least 40 faculty members and fellows volunteered over 200 teaching hours from 11 medical school departments. Student feedback was consistently positive through competency-based curricular evaluations. As a result of its successes, the course is now offered on a biannual basis. DISCUSSION: Experiential, student-centered teaching employed in this course proved successful as an introduction to delivery of evidence-based and culturally sensitive GH. Special emphasis on working with standardized patients in interdisciplinary and cross-cultural simulations provided students with clinical skills applicable for care provided both locally and on international rotations. CONCLUSION: With a special emphasis on cross-cultural sensitivity, this pilot elective trained future practitioners in fund of knowledge, clinical skills, and service delivery methods in GH.