UNICEF's contribution to the adoption and implementation of option B+ for preventing mother-to-child transmission of HIV: a policy analysis.

BACKGROUND: Between 2011 and 2013, global and national guidelines for preventing mother-to-child transmission (PMTCT) of HIV shifted to recommend Option B+, the provision of lifelong antiretroviral treatment for all HIV-infected pregnant women. METHODS: We aimed to analyse how Option B+ reached the policy agenda, and unpack the processes, actors and politics that explain its adoption, with a focus on examining UNICEF's contribution to these events. Analysis drew on published articles and other documentation, 30 key informants interviews with staff at UNICEF, partner organisations and government officials, and country case studies. Cameroon, India, South Africa and Zimbabwe were each visited for 5-8 days. Interview transcripts were analysed using Dedoose software, reviewed several times and then coded thematically. RESULTS: A national policy initiative in Malawi in 2011, in which the country adopted Option B+, rather than existing WHO recommended regimens, irrevocably placed the policy on the global agenda. UNICEF and other organisations recognised the policy's potential impact and strategically crafted arguments to support it, framing these around operational considerations, cost-effectiveness and values. As 'policy entrepreneurs', these organisations vigorously promoted the policy through a variety of channels and means, overcoming concerted opposition. WHO, on the basis of scanty evidence, released a series of documents towards the policy's endorsement, paving the way for its widespread adoption. National-level policy transformation was rapid and definitive, distinct from previous incremental policy processes. Many organisations, including UNICEF, facilitated these changes in country, acting individually, or in concert. CONCLUSIONS: The adoption of the Option B+ policy marked a departure from established processes for PMTCT policy formulation which had been led by WHO with the support of technical experts, and in which recommendations were developed following shifts in evidence. Rather, changes were spurred by a country-level initiative, and a set of strategically framed arguments that resonated with funders and country-level actors. This bottom-up approach, supported by normative agencies, was transformative. For UNICEF, alignment between the organisation's country focus and the policy's underpinning values, enabled it to work with partners and accelerate widespread policy change.

Preparation of sugar-salt solutions.

Correct measurement techniques are essential for the preparation of oral rehydration solutions but dangerous or ineffective solutions may also result from the inherent variability of the method and ingredients. This paper describes an experimental study conducted in Zimbabwe to compare the reliability of three methods for measuring sugar and salt in a 750 ml bottle of water: (i) 6 level teaspoons of sugar and half a level teaspoon of salt, (ii) 3 heaped teaspoons of sugar and half a level teaspoon of salt and (iii) 3 level measures of sugar and salt with a double-ended spoon. The teaspoon and 750 ml bottle methods produced reliable results. Heaped teaspoons of sugar gave more reproducible sucrose concentrations than level teaspoons . The double-ended spoon was not more reliable and gave disquietingly high sodium concentrations with refined salt. Under field conditions the level teaspoon method gave more variable results but still within acceptable limits. It is concluded that a domestic teaspoon and a standard 750 ml bottle can be recommended for the preparation of home-based oral rehydration solutions in rural Zimbabwe.

PIP: Incorrect measurement of the ingredients of oral rehydration solution can result in an ineffective or even dangerous treatment. An experimental study was conducted in Zimbabwe to compare the reliability of 3 methods for measuring sugar and salt in a 750 ml bottle of water: 1) 6 level teaspoons of sugar and 1/2 a level teaspoon of salt; 2) 3 heaped teaspoons of sugar and a 1/2 level teaspoon of salt; and 3) 3 level measures of sugar and salt with a double-ended spoon. A total of 120 solutions were prepared by extension workers; both brown and white sugar and coarse and refined salt were used for each of the 3 measuring methods. In addition, 82 village women prepared a sugar-salt solution following the 1st method in their homes with their own utensils. Most reliable results were produced by the teaspoon and 750 ml bottle methods. Heaped teaspoons of sugar gave more reproducible sucrose concentrations than level teaspoons. The double-ended spoon was not more reliable and gave alarmingly high sodium concentrations when refined salt was used. Under field conditions, the level teaspoon method gave more variable results, but still within acceptable limits (a range of 45-131 mmol/1 for the sucrose and 15-76 mmol/1 for the sodium). Differences due to variability in the coarseness and density of the salt were negligible and no difference was found in terms of the type of sugar used. It is concluded that a domestic teaspoon and standard fruit cordial bottle, which together with sugar and salt are available in most Zimbabwean households, can be recommended for the preparation of home-based oral rehydration solutions in rural areas.

Home-based oral rehydration therapy in rural Zimbabwe.

A study was carried out in four rural areas of Zimbabwe to assess the acceptability, feasibility and accuracy of sugar-salt solutions and to investigate the action taken during a recalled episode of diarrhoea in a child. Only 5% of respondents gave the child a sugar-salt solution at home during the described illness yet a majority (52%) claimed knowledge of oral rehydration techniques. A great variety of recipes were described; 46% of respondents knew a recipe for a solution containing sugar and salt and 12% were able to describe the standard recipe for sugar-salt solutions. Those who knew a recipe for a sugar-salt solution were asked to prepare a sample for chemical analysis; of those who prepared a sample, 26% prepared a solution having both sucrose and sodium concentrations within the safe and effective ranges. Surprisingly therefore, 12% (26% X 46%) of rural adults were able to prepare a safe and effective oral rehydration solution, despite the fact that there is as yet no concerted programme for the promotion of home-based oral rehydration therapy in Zimbabwe. The standard method of preparation was taught to all respondents who had no previous knowledge of sugar-salt solutions. Recall of the standard method was good; after a period of 11 to 26 days 64% of respondents remembered the correct recipe and 84% prepared a solution having both sucrose and sodium concentrations in the safe and effective ranges. 92% of all households had a teaspoon, sugar and salt and 88% had all the required items: a 750 ml bottle, a teaspoon, sugar and salt. It is concluded that home-based oral rehydration therapy using sugar-salt solutions is an acceptable and feasible strategy for the early management of acute diarrhoea in rural Zimbabwe.

PIP: The acceptability, feasibility, and accuracy of sugar-salt solutions and household practices related to the management of infantile diarrhea were investigated in 4 diverse rural areas of Zimbabwe. 52% of the 402 study respondents claimed knowledge of oral rehydration treatment and 46% were able to provide a recipe for sugar-salt solution. 12% of those who volunteered recipes were correct about the various measurements (6 teaspoons of sugar and 1/2 teaspoon of salt in a 750 ml bottle of water). All respondents who indicated knowledge of an oral rehydration solution were asked to demonstrate its preparation; chemical analysis revealed that 26% prepared a solution having sucrose and sodium concentrations within a safe and effective range. Respondents who had no previous knowledge of oral rehydration therapy were instructed in the preparation of the standard sugar-salt solution. At follow-up 11-26 days after this instruction, 64% remembered the correct recipe and 84% prepared an effective solution. 88% of the households included in the survey had all the items required to prepare sugar-salt rehydration solution. Despite the high level of awareness of oral rehydration among respondents, only 5% gave their child such a solution during the most recent episode of diarrhea; 53% took the child to a health facility and 28% administered traditional remedies. Thus, vigorous educational efforts are needed to build on this knowledge base and promote the actual use of sugar-salt solution. To date, there has been no concerted program in rural Zimbabwe for the promotion of home-based oral rehydration therapy.

Careseeking for illness in young infants in an urban slum in India.

Illness in infants in the first two months of life can take a precipitous life-threatening course, and requires timely and appropriate medical assessment and management. We conducted a focused ethnographic study of illness in young infants and associated careseeking practices in an urban slum in New Delhi, India, in order to identify the constraints in securing effective care for severe illness in this age group. The findings suggest that maternal recognition of illness is not a limiting factor in the use of health care services for sick young infants in this setting. Mothers respond to a number of important signs of illness, including changes in the young infant's sleeping or feeding behavior, and they are usually prompt in seeking care outside the home. They are not able, however, to discriminate among the many sources of health care available in this setting, and give preference to local unqualified private practitioners. Most practitioners, including qualified medical practitioners, display critical failures in the assessment and management of sick young infants. The continuity and effectiveness of care is further compromised by the caretakers' expectations of rapid cure, which result in discontinued treatment courses and frequent changes in practitioners, and by their reluctance to seek hospital care. The implications of these findings for the design of programs to reduce young infant mortality are discussed. In particular, the feasibility and acceptability of hospital referrals according to current program guidelines are called into question.

Perceptions of childhood diarrhoea and its treatment in rural Zimbabwe.

In the course of a study on the acceptability and feasibility of home-based oral rehydration therapy in rural Zimbabwe, information was collected on attitudes and beliefs about diarrhoea and on action taken in response to an episode of diarrhoea in a child. Diarrhoea was found to be a perceived threat at community and family level and numerous possible causes of diarrhoea were described which were assigned to two broad classes: (1) 'physical' causes, such as a polluted environment, diet and teething and (2) 'social and spiritual' causes such as those associated with a depressed fontanelle. These domains were not, however, mutually exclusive; 76% of the described episodes of diarrhoea were attributed to 'physical' causes, 15% to 'social and spiritual' causes and 8% to a combination of both. Reported utilization rates of the formal health services were unexpectedly high. In contrast, we recorded a low demand for indigenous herbalists (n'angas). Home management was common and comprised the administration of indigenous herbal remedies, of sugar and salt solutions, of over-the-counter drugs or of enemas. These remedies were given on their own or alongside the treatment prescribed by a health worker. A number of variables were examined to assess their influence on health-seeking behaviour: perceived cause and severity of the illness, socio-demographic characteristics of the respondent or child and accessibility of the health services.(ABSTRACT TRUNCATED AT 250 WORDS)

Indigenous plant remedies in Zimbabwe.

Two household surveys undertaken in Zimbabwe between 1981 and 1983 revealed extensive use of indigenous plant remedies in the home-management of childhood diarrhoea and many adult illnesses. Names of the local plants, trees and shrubs are listed, together with the part of the plant used and the type of condition treated. The usage of medicinal plants underscores the need for further study of indigenous pharmacopoeias and the therapeutic properties of plants. The role of indigenous plant remedies within local health care systems is also worthy of closer investigation.

Breast feeding in the first six months.

PIP: Virtually all mothers in developing countries tend to supplement breast milk with water or teas, often during the infant's 1st week, thinking that these fluids have therapeutic effects. Moreover many physicians encourage this practice. It is unnecessary and could adversely affect infant health. Exclusively breast fed infants are less likely to suffer from diarrhea. For example, studies in the Philippines and Peru show that 6 month old breast fed infants who also received other fluids suffered from diarrhea at twice the rate of those who were exclusively breast fed. Further a study in Brazil reveals that these infants were more likely to die than those who only received breast milk. Moreover infants who received fluids other than breast milk consume less breast milk and breast feed for shorter duration than exclusively breast fed infants. In Brazil, breast fed infants who received supplements in the 1st days of life were 2 times as likely to not breast feed after 3 months than exclusively breast fed infants. Thus growth in infants who receive water or teas will not be optimal. Another benefit of breast feeding that supplements erode include increased birth intervals. Moreover research consistently shows that healthy infants who receive enough breast milk to meet their energy needs also receive enough fluid to meet their requirements, even in hot and dry environments. Improved maternity services following delivery increases exclusive breast feeding rates during the 1st few weeks of life. These services include telling all pregnant women how and why to breast feed, helping mothers start breast feeding soon after delivery, rooming in 24 hours/day, encouraging breast feeding on demand, and giving no other fluids, except for required medications. Further working mothers should have the right to breast feed. Support groups and health workers should encourage mothers to exclusively breast feed for the 1st 6 months.^ieng

Interventions for the control of diarrhoeal diseases among young children: chemoprophylaxis.

A number of situations place young children at increased risk of diarrhoea. Among these, the best documented in developing countries is contact with a diarrhoea case in a family or household. The most common application of chemoprophylaxis in developing countries is to prevent cholera or shigellosis among household contacts of known cases. There is little evidence that chemoprophylaxis is effective in reducing diarrhoea morbidity and mortality, except perhaps in travellers. Theoretical calculations in this paper (based on optimistic assumptions) suggest that chemoprophylaxis of household contacts of known cholera cases in Bangladesh might reduce overall diarrhoea incidence rates in children under 5 years of age by 0.02-0.06% and diarrhoea mortality rates by 0.4-1.2%. Chemoprophylaxis of household contacts of known shigellosis cases might reduce overall diarrhoea incidence rates by 0.15-0.35% and diarrhoea mortality rates by 0.3-0.7% in the same age group. The correct identification of index cases of cholera and shigellosis, followed by the rapid distribution of drugs to their household contacts, requires skills and resources that are scarce in the developing countries. Chemoprophylaxis can contribute to the widespread emergence and dissemination of antimicrobial resistance. The available evidence suggests that chemoprophylaxis is not feasible in many settings and that, even if successfully implemented, it is not a cost-effective intervention for national diarrhoeal diseases control programmes.

Interventions for the control of diarrhoeal diseases among young children: rotavirus and cholera immunization.

PIP: The potential effects of rotavirus and cholera immunization (with an improved vaccine) on diarrhea morbidity and mortality among young children are reviewed using data from field studies and theoretical calculations. In developing countries, rotavirus may be responsible for about 6% of all diarrhea episodes and 20% of all diarrhea deaths in children under age 5. In industrial countries, these proportions may be higher. Rotavirus immunization may reduce overall diarrhea morbidity rates by 2-3% and diarrhea mortality rates by 6-10% among children under 5 in developing countries, depending on vaccine efficacy and program coverage. The impact of improved cholera vaccines depends on the prominence of cholera as a cause of diarrhea, and this varies greatly from country to country. Taking the extreme example of Bangladesh, where cholera is endemic and may account for about 0.4% of all diarrhea episodes and 8% of all diarrhea deaths in children under 5 years of age, cholera immunization might reduce overall diarrhea morbidity rates by 0.06-0.13% and diarrhea mortality rates by 1-2% among these children. The similar incidence rates in industrial and developing countries suggest that rotavirus diarrhea may not be controlled by improvements in water supply, sanitation, or hygiene. Control may depend on the widespread use of an effective vaccine. (author's)^ieng

Ethical challenges in efficacy trials of vaginal microbicides for HIV prevention.

This paper discusses some of the ethical challenges raised by advanced clinical trials designed to assess the safety and efficacy of vaginal microbicides in protecting women from HIV infection. The ethical principles that guide clinical research involving human subjects require that all participants in such trials be provided available measures known to reduce the risk of HIV infection. However, this will reduce the ability of the study to assess the protective effect of the test microbicide. In addition, providing extensive services to trial participants may be construed as an undue inducement if the study is being conducted among vulnerable groups such as sex workers or women from disadvantaged communities. Suggestions are provided to resolve this dilemma in the planning and implementation of HIV prevention services for trial participants.

Issues in the design and interpretation of studies to evaluate the impact of community-based interventions.

Increasingly, epidemiologists are faced with the need to evaluate the impact of an intervention that is delivered at the level of a community or cluster of individuals, rather than at the individual level. This has profound implications for the design and interpretation of a study to evaluate its impact. We start by discussing the issues arising in the extension of the randomized double-blind controlled trial methodology to the evaluation of interventions delivered to clusters of individuals, or to whole communities, where the unit of randomization is a cluster of individuals rather than an individual. We then consider alternative approaches to design, discuss their relative strengths and weaknesses and present a framework of design options. Finally we propose a pragmatic approach to evaluation design in this setting. We believe that the answer lies in the judicious selection of different design elements, combined in such a way that when the evidence from each is presented together, a clear picture of the impact of the intervention emerges. We illustrate this using an example from the recent literature.

The magnitude of the global problem of diarrhoeal disease: a ten-year update.

In order to update global estimates of diarrhoeal morbidity and mortality in developing countries, we carried out a review of articles published from 1980 to the present and calculated median estimates for the incidence of diarrhoea and diarrhoeal mortality among under-5-year-olds. The incidence of diarrhoea obtained (2.6 episodes per child per year) was virtually the same as that estimated by Snyder & Merson in 1982, while the global mortality estimate was lower (3.3 million deaths per year; range, 1.5-5.1 million). The mortality estimate is based on a small number of active surveillance and prospective studies, and thus associated with a large degree of uncertainty, reflecting the weakness of the global database. However, many surveys reporting reductions in mortality in several locations are consistent with a decreased estimate for mortality. More accurate execution of WHO survey methods, including population-based sampling in representative locations, and repeat surveys every 5 years, are needed to monitor the progress of diarrhoeal disease control programmes and trends in diarrhoeal morbidity and mortality over time.

Research steps in the development and evaluation of public health interventions.

Presented is a conceptual framework for planning intervention-related research. Altogether, nine steps in the process of developing and evaluating public health interventions are specified. This process is dynamic and iterative, and all steps are not always required, or need follow in sequence. The framework can be used to set research priorities by verifying where there is sufficient knowledge to move forward and by identifying critical information gaps. It can also help select appropriate research designs, as each step is characterized by certain types of studies. Greater effort is required to move beyond descriptive epidemiological and behavioural studies, to intervention studies. Field trials of public health interventions require particular attention as they are often neglected, despite their significance for public health policy and practice.

Syndromic management of vaginal discharge among women in a reproductive health clinic in India.

OBJECTIVES: To examine the performance of the syndromic approach in the management of vaginal discharge among women attending a reproductive health clinic in New Delhi, India. METHODS: Women who sought services from the clinic and who had a complaint of vaginal discharge were interviewed, underwent a pelvic examination, and provided samples for laboratory investigations of bacterial vaginosis, candidiasis, syphilis, trichomoniasis, and Chlamydia trachomatis and Neisseria gonorrhoeae infections. Data analysis focused on the prevalence of infection and on the performance of the algorithm recommended by the national authorities for the management of vaginal discharge. RESULTS: The most common infection among 319 women was bacterial vaginosis (26%). At least one sexually transmitted infection was detected in 21.9% of women. The prevalence of C trachomatis infection was 12.2%; trichomoniasis 10%; syphilis 2.2%; N gonorrhoeae was not isolated. An algorithm based on risk assessment and speculum assisted clinical evaluation was not helpful in predicting cervical infections associated with C trachomatis (sensitivity 5% and PPV 9%). This algorithm was sensitive (95%) though not specific (22%) in selecting women for metronidazole therapy effective against bacterial vaginosis or trichomoniasis, and overtreatment was a problem (PPV 38%). The sensitivity, specificity, and PPV of this algorithm for the treatment of candidiasis were 46%, 98%, and 88% respectively. The cost per case assessed using the algorithm was $2 and the cost per infection correctly treated was $4.25. CONCLUSIONS: The prevalence of cervical infection associated with C trachomatis was high among these "low risk" women. The syndromic approach is not an efficient tool for detecting this condition, and alternative approaches to evaluation and intervention are required. The syndromic management of vaginal discharge among women seeking family planning and other reproductive health services should focus on vaginal infections, thus enhancing quality of care and addressing women's concerns about their health.