Are there adverse consequences of quizzing during informed consent for HIV research?

INTRODUCTION: While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand. METHODS: Enrolment procedures included an informed consent comprehension quiz. An informed consent survey followed. RESULTS: 525 participants completed the informed consent survey (Heng County, China»255, Xinjiang, China»229, Chiang Mai, Thailand»41). Mean age was 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). In multivariate analysis, lower educational level was associated with not minding the quizzing (6e10 yrs vs 0e5 yrs: OR»0.27, p»0.03; more than 11 yrs vs 0e5 yrs: OR»0.18, p»0.03). There were also site differences (Heng County vs Xinjiang) in feeling anxious (OR»0.07; p»<0.01), not minding (OR»0.26; p»0.03), being bored (OR»0.25; p»0.01) and not finding the questions easy (OR»0.10; p»<0.01). CONCLUSIONS: Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent. TRIAL REGISTRATION: clinicaltrials.gov number NCT00270257.

The process of HIV status disclosure to HIV-positive youth in Kinshasa, Democratic Republic of the Congo.

As access to HIV/AIDS treatment increases in sub-Saharan Africa, greater attention is being paid to HIV-infected youth. Little is known about how HIV-positive youth are informed of their HIV infection. As part of a larger formative study informing a treatment program in Kinshasa, Democratic Republic of the Congo, semi-structured interviews were conducted with 19 youth (10-21 years) who had previously been told their HIV status and 21 caregivers who had disclosed the youth's HIV status to the youth. Questions explored youth's and caregivers' experiences of and immediate reactions to disclosure. Youth's median age at disclosure was 15 years old, with a range of 10-18 years based on caregiver reports (n=21) and from 10-19 years based on youth reports (n=18). The most common reasons spontaneously given for disclosing were the child's adherence to their treatment regimen (5/16), the need of the child to protect her/himself or stay healthy (5/16), the child's increasing age (4/16) and so that the child would know why they are suffering (3/16). Most youth (16/19) were surprised to learn of their diagnosis; 50% (8/16) wondered about the infection's origins. A large majority felt that it is better for them to know their HIV status (88%; 15/17). HIV care and treatment programs must be prepared to address the psychosocial needs of youth and their caregivers during the disclosure process.

Patient and provider perspectives on implementation models of HIV counseling and testing for patients with TB.

SETTING: TB clinics in Kinshasa, Democratic Republic of Congo. OBJECTIVES: To identify an acceptable approach to human immunodeficiency virus (HIV) counseling and testing (CT) for patients with tuberculosis (TB) from health care worker (HCWs) and patient perspectives. DESIGN: A qualitative evaluation was conducted of three models of routine provider-initiated HIV CT: off-site referral to a freestanding voluntary counseling and testing (VCT) center, on-site referral for HIV CT at the primary health care center to which the TB clinic belongs and HIV CT by the TB nurse. RESULTS: Incorporating HIV CT into routine TB care was supported by HCWs (96%) and patients (99%). The trusting patient-provider relationship was a primary reason why most HCWs (74%) and patients (68%) preferred the HIV CT by TB nurse model. Patients also cited continuity of care and potential optimisation of the management of HIV co-infected patients as reasons. Some patients and HCWs were concerned about confidentiality issues (HIV status documentation and privacy of counseling) and the potential difficulty of refusing routine HIV CT when it was offered by TB nurses. Some HCWs also expressed worry about the increased workload. CONCLUSION: Qualitative data provided insight into reasons for the high uptake observed of routine HIV CT offered by TB nurses and identified potential concerns when implementing this model.

Hantavirus pulmonary syndrome in the Americas: the early years.

The initial recognition of hantavirus pulmonary syndrome (HPS) as a new disease associated with a cluster of acute respiratory deaths among American Indians in the southwestern United States in 1993 bears little resemblance to the current understanding of this syndrome. HPS is now recognized as a zoonotic disease that has been endemic throughout the Americas for at least 40 years and that is closely linked to population densities and virus dynamics among a specific subfamily of rodents. The classic disease description has also been markedly broadened to include a spectrum of illness that ranges from asymptomatic infection to fulminate cardiorespiratory failure. Clinical variants with hemorrhagic or prominent renal manifestations have also been recognized. Prevention efforts have been targeted at minimizing peri-domestic contact with rodents and their excreta and improving clinical recognition of infection. This paper describes the pathogenesis underlying the profound cardiorespiratory compromise, person-to-person transmission reported in South America, and viable treatment modalities.

[Registry of genetic and malformative diseases in the province of Macerata]. / Registro delle malattie genetiche e malformative della provincia di Macerata.

OBJECTIVES: The aim of this epidemiological research is to evaluate the prevalence of genetic diseases and malformative syndromes in paediatric population living in the Macerata county. MATERIAL AND METHODS: All the data were collected through a careful analysis of a specific questionnaire sent to all the family paediatricians. RESULTS: 23,379 children living in Macerata county, aged 0 to 9 years, were evaluated (93.8% of all this paediatric population). Among those were found N 400 cases of genetic diseases and malformative syndromes: Malformations Tot.N. 255 cases (63.3% of the reported cases); Malformative Syndromes Tot. N. 55 cases (27.8% of the reported cases); Endocrinology and Metabolic Diseases Tot. N. 41 cases (10.3% of the reported cases); Osteochondrodysplasia Tot. N. 22 cases (5.7% of the reported cases); Other Tot. N. 28 cases (7.0% of the reported cases); Male population was found more affected than female: M/F ratio = 1.4. The analysis of the data showed an increasing trend in detecting these pathological conditions, consistent with the increase in geographic altitude (3 areas considered): 0-100 meter = 0.88%; 100-600 m.a.s. = 1.34%; over 600 m.a.s. = 1.88%. CONCLUSION: The knowledge of the number of children affected by genetic and malformative diseases in the Macerata county is relevant in order to establish a Genetic Service with the aim to better support the medical assistance of these patients and counselling service for the families.