Adherence Self-Management and the Influence of Contextual Factors Among Emerging Adults With Human Immunodeficiency Virus.

BACKGROUND: Maintaining adherence to antiretroviral therapy (ART) is a significant challenge for human immunodeficiency virus (HIV)-infected racial and ethnic minority adolescents and young adults (youth). Given the consequences of suboptimal ART adherence, there is a pressing need for an expanded understanding of adherence behavior in this cohort. OBJECTIVES: As part of an exploratory sequential, mixed-methods study, we used qualitative inquiry to explore adherence information, motivation, and behavioral skills among HIV-infected racial and ethnic minority youth. Our secondary aim was to gain an understanding of the contextual factors surrounding adherence behavior. METHODS: The information-motivation-behavioral skills model (IMB model) was applied to identify the conceptual determinants of adherence behavior in our target population, along with attention to emergent themes. In-depth, individual, semistructured interviews, including open-ended questions with probes, were conducted with a convenience sample of HIV-infected racial and ethnic minority youth (ages 16-29 years), receiving ART and with evidence of virologic failure (i.e., detectable HIV viral load). New participants were interviewed until information redundancy was reached. Qualitative interviews were digitally recorded, transcribed verbatim, and analyzed using Atlas.ti (v8). Directed content analysis was performed to generate categories and broad themes. Coding was initially conceptually driven (IMB model) and shifted to a data-driven approach, allowing for the discovery of key contextual factors that influence adherence behavior in this population. Methodological rigor was ensured by member checks, an audit trail, thick descriptive data, and triangulation of data sources. RESULTS: Twenty racial and ethnic minority participants (mean age = 24.3 years, 55.0% male) completed interviews. We found adherence information was understood in relation to HIV biomarkers; adherence motivation and behavioral skills were influenced by stigma and social context. We identified five primary themes regarding ART self-management: (a) emerging adulthood with a chronic illness, (b) stigma and disclosure concerns, (c) support systems and support deficits, (d) mental and behavioral health risks and challenges, and (e) mode of HIV transmission and perceptions of power and control. DISCUSSION: Key constructs of the IMB model were applicable to participating HIV-infected youth yet did not fully explain the essence of adherence behavior. As such, we recommend expansion of current adherence models and frameworks to include known contextual factors associated with ART self-management among HIV-infected racial and ethnic minority youth.

Stress-induced cardiomyopathy: not always apical ballooning.

Apical ballooning (takotsubo syndrome) mimics acute myocardial infarction with transient apical dyskinesia and normal coronary arteries. It is often precipitated by emotional or physical stress. The prevalence of this syndrome has been increasing, probably because it is now more frequently recognized. Multiple theoretical hypotheses have been developed to explain its genesis, but the mechanism remains unclear. Rarely, cases of apical sparing and other wall motion involvement have been cited. We collected data on 12 patients who had acute myocardial infarction and normal coronary arteries with abnormal wall motion that had completely healed on repeat studies. Five patients had typical apical ballooning, and the other 7 had wall motion abnormalities in other segments. We determined that stress-induced cardiomyopathy can involve any wall of the myocardium and is not always apical ballooning.

Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial.

OBJECTIVE: Women need products that protect against both pregnancy and sexually transmitted infections, including human immunodeficiency virus (HIV). The acid buffering gel is a nondetergent spermicide that may provide this dual protection by reinforcing normal vaginal acidity to inactivate both sperm and acid-sensitive sexually transmitted pathogens. The objective of this study was to assess the gel's contraceptive effects, safety, and acceptability. METHODS: We conducted a multicenter, randomized, double-masked, noninferiority study at 11 centers, comparing 621 women who used an acid buffering gel plus diaphragm with 300 women who used a nonoxynol-9 spermicide plus diaphragm for 6 months. A double-masked study extension followed 234 women for an additional 6 months of use. RESULTS: The 6-month pregnancy rate per hundred women was 10.1% (95% confidence interval [CI] 7.1-13.1%) for acid buffering gel and 12.3 (95% CI 7.7-16.9) for nonoxynol-9 spermicide users. The difference in rates was -2.2% with a 95% CI -7.7 to 3.3%. Consistent and correct use 6-month pregnancy rates were 4.7% for acid buffering gel and 6.1% for nonoxynol-9 spermicide users, calculated from those cycles where diary entries indicated such use. Adverse events and acceptability were similar between the two groups. Pregnancy probabilities were similar between groups participating in the 12-month study extension. CONCLUSION: An acid buffering gel used with a diaphragm is a safe, acceptable contraceptive with efficacy comparable to that of a common commercial spermicide with diaphragm. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00065858 LEVEL OF EVIDENCE: I.

Key Considerations in the Transition to Risk-Based Monitoring.

In the 2 years since publication of the European Medicines Agency's "Reflection Paper on Risk Based Quality Management in Clinical Trials" and US Food and Drug Administration's "Draft Guidance for Industry: Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring," the methodologies, products, and services for risk-based monitoring have proliferated and diversified. The biopharmaceutical industry can choose from a variety of general approaches and specific practices. This article provides a framework to assist biopharmaceutical companies in selecting and implementing a risk-based monitoring approach or selecting a service provider. The framework includes discussion of different approaches to source data verification but also discusses other important dimensions of risk-based monitoring: individualization of the monitoring approach for each study; error detection and correction, including but not limited to source data verification; real-time quality management; error prediction and prevention; and adoption and implementation.

Suspected vasculitis in an adolescent female with cardiomyopathy, myocardial infarction, and heart failure requiring heart transplantation.

A 15-year-old girl presented with dilated cardiomyopathy, positive cardiac markers, and electrocardiogram changes suggestive of acute coronary syndrome. Coronary angiography showed giant dilated coronary arteries. Pathological evidence for cardiomyopathy with acute myocardial infarction was present in the explanted heart. Further investigation suggested evidence for a systemic vasculitis: polyangiitis overlap syndrome.

ST-segment elevation myocardial infarction: recommendations on triage of patients to heart attack centers: is it time for a national policy for the treatment of ST-segment elevation myocardial infarction?

Despite substantial progress in the diagnosis and treatment of acute ST-segment elevation myocardial infarction (STEMI), implementation of this knowledge into routine clinical practice has been variable. It has become increasing clear that primary percutaneous coronary intervention (PCI) is the preferred method of reperfusion if it can be performed in a timely manner. Recent European data suggest that transfer for direct PCI may also be preferable to fibrinolytic therapy. We believe it is time to establish a national policy for treatment of patients with STEMI to develop a coordinated system of care similar to that of the level 1 trauma system.