Measuring Adherence by Visual Inspection of Returned Empty Gel Applicators in the CAPRISA 004 Microbicide Trial

In the CAPRISA 004 trial, adherence was estimated as the proportion of reported sex acts covered by two gel doses, which was assessed by counting returned empty gel applicators. The returned empty applicators were inspected visually in a standardized manner for residue on the outside of the applicator, as an indicator of vaginal insertion. Over 15 months, spanning 11,839 study visits by 838 women, a total of 59,800 returned empty applicators were inspected. By visual assessment, 77.5 % of these applicators appeared to have been inserted. To test the accuracy of the assessment we fitted a Cox model and found that the risk for HIV infection was doubled when less than half of the returned empty applicators had been assessed as not inserted in the vagina. Visual inspection enhanced both the accuracy of the adherence measurement and aided identification of mechanical problems with applicator use experienced by women in the trial.     

EAACI position paper on diet diversity in pregnancy,infancy and childhood: Novel concepts and implications for studies in allergy and asthma

To fully understand the role of diet diversity on allergy outcomes and to set standards for conducting research in this field, the European Academy of Allergy and Clinical Immunology Task Force on Diet and Immunomodulation has systematically explored the association between diet diversity and allergy outcomes. In addition, a detailed narrative review of information on diet quality and diet patterns as they pertain to allergic outcomes is presented. Overall, we recommend that infants of any risk category for allergic disease should have a diverse diet, given no evidence of harm and some potential association of benefit in the prevention of particular allergic outcomes. In order to harmonize methods for future data collection and reporting, the task force members propose relevant definitions and important factors for consideration, when measuring diet diversity in the context of allergy. Consensus was achieved on practice points through the Delphi method. It is hoped that the definitions and considerations described herein will also enable better comparison of future studies and improve mechanistic studies and pathway analysis to understand how diet diversity modulates allergic outcomes.     

Functional performance study of an adapted design of the woman’s condom: a crossover,noninferiority, randomized clinical trial

Objectives: We aimed to assess the functional performance and safety of a modified Woman’s Condom (WC2) against the existing FC2 female condom.

Study design: This randomized clinical trial enrolled 287 women in one South African site. The primary outcome of the study was the rate of female condom failure. Participants were asked to use five of each female condom type and to collect information on use in a condom log at home and were interviewed after use of each FC type.

Results: Noninferiority was demonstrated for the WC2 with respect to the reference condom FC2 for all condom functions. The WC2 was found to be superior to the FC2 reference condom for clinical failure (p?=?.000), total female condom failure (p?=?.001), misdirection (p?=?.000) and slippage (p?=?.004).

Conclusion: The WC2 female condom performs as well as the FC2 female condom and offers good stability during use.

Implications: Results from this study will inform further refinement of this female condom design, resulting in a new and potentially less expensive Woman’s Condom.     

Primary health care in Swaziland: is it working?

A historical picture of health services in Swaziland and an analysis of primary health care services from 1983 to 1995 are presented. The paper gives background information on health and health services, including education and training of health workers and health status indicators. Evaluations of the primary health care strategy since its inception in 1983 are discussed. Successes are identified and areas where improvement is needed to achieve the WHO goal of'Health For All'are suggested.     

Serine residues 338 and 339 in the carboxyl-terminal tail of the type II gonadotropin-releasing hormone receptor are critical for beta-arrestin-independent internalization

Cloned mammalian type II GnRH receptors have a carboxyl-terminal tail in contrast to the mammalian type I GnRH receptors, which uniquely lack a carboxyl-terminal tail. Because this domain mediates internalization of many serpentine receptors, the internalization pathway of the marmoset monkey type II GnRH receptor and the functional role of the carboxyl-terminal tail in internalization was studied. The internalization pathway of the type II GnRH receptor was investigated in COS-1 cells by coexpressing G protein-coupled receptor kinases (GRKs), dynamin-1, and beta-arrestins. Internalization of the receptor requires GRKs and dynamin but does not require beta-arrestin. The type II GnRH receptor can also internalize via beta-arrestin in the presence of exogenous beta-arrestins, suggesting that the receptor can use two distinct internalization pathways. Receptor internalization appears to occur via clathrin-coated pits and caveolae because disruption of either structure inhibits internalization. Progressive truncations of the carboxyl-terminal tail identified a region containing serine residues 338 and 339 as critical for receptor internalization. Substitution of these serine residues with alanine residues inhibited internalization, whereas substitutions with glutamic acid residues rescued internalization. Furthermore, a dominant-negative GRK2 did not inhibit internalization of receptors having these serine substitutions, although it inhibited internalization of the wild-type receptor. These results together identify serine residues 338 and 339 in the carboxyl-terminal tail as critical for internalization of the type II GnRH receptor and suggest that these residues undergo phosphorylation by GRKs. However, neither of these residues, nor the carboxyl-terminal tail, is required for beta-arrestin-dependent internalization.     

Inequities in access to health care in South Africa

Achieving equitable universal health coverage requires the provision of accessible, necessary services for the entire population without imposing an unaffordable burden on individuals or households. In South Africa, little is known about access barriers to health care for the general population. We explore affordability, availability, and acceptability of services through a nationally representative household survey (n = 4668), covering utilization, health status, reasons for delaying care, perceptions and experiences of services, and health-care expenditure. Socio-economic status, race, insurance status, and urban-rural location were associated with access to care, with black Africans, poor, uninsured and rural respondents, experiencing greatest barriers. Understanding access barriers from the user perspective is important for expanding health-care coverage, both in South Africa and in other low- and middle-income countries.