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[Unpublished] 1999.  p.This statement regards the Convention on the Rights of the Child in Poland and other Eastern and Central European countries. It discusses initiatives that the participants urge all governments to implement for children's rights and to eliminate child poverty, discrimination, and dangerous work situations.
Contraception Report. 1999 Jan; 9(6): p..A recent WHO-sponsored study has demonstrated that the progestin levonorgestrel, used alone, is a highly effective and well-tolerated form of emergency contraception. With the proportion of pregnancies prevented up to 95% - depending on the timeliness of administration - the levonorgestrel regimen proved more effective than the most commonly used regimen, the Yuzpe method. The Yuzpe method employs a dual-hormone (ethinyl estradiol plus levonorgestrel) approach to preventing pregnancy. Despite the Yuzpe regimen's 75% efficacy rate (a weighted average from 10 studies) the method has been associated with drawbacks. About 50% of users experience nausea and 20% report vomiting, which can reduce patient compliance. (excerpt)
Getting down to business. Expanding the private commercial sector's role in meeting reproductive health needs.
Washington, D.C., Population Action International, 1999. 76 p.Around the world, there is an emerging consensus that private enterprise is the engine of economic growth and development. Market forces are widely accepted as the most dynamic and efficient mechanisms for meeting society's demands for goods and services, especially in the productive economic sectors such as agriculture and industry. Even in the social sectors, where governments have traditionally played a greater role, there is growing recognition that the private for-profit sector can help meet the public's demand for education and health care. In reproductive health, as in other areas of health care, the private sector's potential importance lies in the inadequacy of public funding relative to growing needs. New and innovative approaches involving the private sector are required to bridge this gap between stagnating financial resources and the rapidly increasing demand for reproductive health care. Yet in most developing countries, the private sector is not fulfilling its potential to help meet reproductive health needs, often because governments have not created a sufficiently supportive environment. Developing country governments and international donor agencies do not adequately appreciate the private sector's contribution to reproductive health. Most governments and donors lack awareness of how their own policies and programs either encourage or deter the private sector from playing a larger role in reproductive health. (excerpt)
Potential interventions for the prevention of childhood pneumonia in developing countries: improving nutrition.
American Journal of Clinical Nutrition. 1999 Sep; 70(3):309-320.Acute respiratory infections are the leading cause of childhood death in developing countries. Current efforts at mortality control focus on case management and immunization, but other preventive strategies may have a broader and more sustainable effect. This review, commissioned by the World Health Organization, examines the relations between pneumonia and nutritional factors and estimates the potential effect of nutritional interventions. Low birth weight, malnutrition (as assessed through anthropometry), and lack of breast-feeding appear to be important risk factors for childhood pneumonia, and nutritional interventions may have a sizeable effect in reducing deaths from pneumonia. For all regions except Latin America, interventions to prevent malnutrition and low birth weight look more promising than does breast-feeding promotion. In Latin America, breast-feeding promotion would have an effect similar to that of improving birth weights, whereas interventions to prevent malnutrition are likely to have less of an effect. These findings emphasize the need for tailoring interventions to specific national and even local conditions. (author's)
Geneva, Switzerland, UNAIDS, 1999 May. 145 p. (UNAIDS Best Practice Collection. Key material; UNAIDS/99.26E)Since early in the epidemic, enquiry into the factors influencing HIV-related vulnerability has been recognized as essential for prevention efforts. While much early work focused on the individual determinants of sexual and drug-related risk-taking, increasingly the contextual factors which render some groups more vulnerable than others has come to be recognized. Factors as diverse as age, gender, social position, economic status, cultural norms, beliefs and expectations determine the risks faced, and enable and constrain individuals in their actions. It is now widely recognized that both individual persuasion and social enablement are essential for programme success, and increasing numbers of prevention programmes and activities are designed on this assumption. The recent UNAIDS report Expanding the Global Response to HIV/AIDS Through Focused Action recognizes the importance of such an approach and seeks to encourage its application in countries across the world. Yet knowing how to develop and fine-tune programmes requires insight into the often complex determinants of behaviour in specific cultural settings and contexts. Good quality social enquiry has a key role to play in providing this information and in supporting the development of work that is attuned to the needs of particular groups. (excerpt)
Geneva, Switzerland, UNAIDS, 1999 Jun. 55 p. (UNAIDS/99.29E)We live at a turning point in human history. AIDS spotlights all that is strong and weak in humanity: our vulnerability and fears, as well as our strength and compassion, especially for those more vulnerable, less able, or poorer than ourselves. There is still no cure and no vaccine for AIDS. In 1998, 16 000 individuals were infected with HIV every day, and by year's end over 33 million people, a number that exceeds the entire population of Canada, were living with HIV -- although we estimate that nine-tenths of them are unaware of their infection. Most people with HIV or AIDS have no access to medication, even to relieve their pain and suffering. Over 14 million adults and children have already lost their lives to the disease. These deaths will not be the last -- there is worse to come. Every year AIDS takes new directions: India and South Africa, both relatively untouched only a few years ago, now have among the fastest-growing epidemics in the world. New AIDS epidemics are emerging with frightening speed in Eastern and Central Europe. And sub-Saharan Africa remains the hardest-hit region in the world. Globally, young people -- those who must build the bridges, create national wealth and conduct the research of the future -- experience half of all new HIV infections. In many parts of the world, AIDS is the single greatest threat to economic, social and human development. (excerpt)
Journal of Tropical Pediatrics. 1999 Dec; 45:322.A number of errors of detail appeared in the editorial Improving Severe Malnutrition Case Management in the February 1999 edition of the Journal of Tropical Pediatrics. These could have potentially serious consequences and the errors are regretted. Infection: severely malnourished children invariably have one or more infections. The normal clinical signs, however, are often absent and so all children should be presumed to have silent infection and routinely be given broad-spectrum antibiotics, rather than for prophylaxis as stated. (excerpt)
Journal of Tropical Pediatrics. 1999 Apr; 45(2):64-65.The Joint United Nation Programme on HIV/AIDS (UNAIDS) chose 'Children Living in a World with AIDS' as its theme for the 1997 World AIDS Campaign. The overall aim of the campaign was to create 'an increased understanding of the HIV/AIDS epidemic and its global dimensions, with an emphasis on promoting action and social policies to prevent HIV transmission and to minimise the epidemic's impact on children, their families and their communities'. Among the facts that emerged in the UNAIDS documentation for this campaign were the following: everyday 1000 children become infected with HIV; of the 1.5 million people worldwide who died of AIDS in 1996, 350 000 were children; AIDS may increase infant mortality by as much as 75 per cent and under-5 child mortality by more than 100 per cent in the regions most affected by the disease by the year 2000; 90 per cent of HIV positive children under the age of 15 years are infected through vertical mother to child Transmission; nearly 1 million children are living with HIV and suffer the physical and psychological consequences of infection; over 9 million children are estimated to have lost one or other or both parents to AIDS. (excerpt)
Asia Pacific Journal of Clinical Nutrition. 1999; 8(4):285.Trends in malnutrition continue to deteriorate in Sub-Saharan Africa (SSA) despite global progress made over the past 50 years in improving the basic human development indicators. One of the major contributing factors to this poor nutritional situation in SSA has been the lost decade of the 1980s due to the structural adjustment and debt burdens of most countries. The poor economic situation and social crisis in SSA have resulted in an increase in the number of impoverished people, with the majority of those classified as being middle class in the 1970s moving to upper lower class and lower middle class positions in society. The number of those living on the poverty line, at below US$1 a day, has also increased. The outcome is a decline in the quality of life, mostly among women and children, with malnutrition and its functional impairments as the greatest consequence. Thus, reducing or eradicating poverty represents the main strategy for nutrition improvement in SSA. Several UN conferences have provided a basis for developing new forms of regional support for eradicating malnutrition in Sub-Saharan Africa. The most relevant to nutrition improvement are the World Summit for Children 1990, the United Nations Conference on Environment and Development 1992, International Conference on Nutrition 1992, International Conference on Population and Development 1994, World Summit for Social Development 1995, Beijing 1995 and the World Food Summit 1996. (excerpt)
Manila, Philippines, World Health Organization [WHO], Regional Office for the Western Pacific, STI, HIV and AIDS Focus, 1999.  p.This publication discusses state-of-the-art methods to detect eleven RTI. The types of assay presented fall into several categories and include detection of the organism by direct microscopy, detection of metabolic products, culture, and the detection of specific antibodies, antigens, DNA or RNA. Not all organisms can be detected using all types of assay, nor can all laboratories perform all types of assay. Thus, the methods that are most useful in detecting each organism are summarized, as well as their sampling procedures, sensitivity and specificity, the advantages and disadvantages of laboratory testing, the appropriate level of use, the training and equipment required, the ease of performance, and the indicative cost of reagents (at current rates in the United States of America). Detailed instructions for carrying out each test can be found in the manufacturer’s manual accompanying each test kit and should be strictly adhered to. The sensitivity and specificity of an assay will vary depending on the method used as the standard and the prevalence of the disease in the population tested. The assay sensitivity and specificity figures in this publication are based on a range of values taken from many different sources, including all types of patient population. (excerpt)
UN Chronicle. 1999 Summer; 36(2): p..What does it take to get girls in school and keep them there? This is a key question, as the United Nations and its partners move towards ensuring the right of every child to a basic education. Yet, fully two thirds of the out-of-school children are girls, many of them out of school by virtue of discrimination on the basis of gender alone. With regard to girls' education, progress is being made and experience gained worldwide, and the related knowledge base is expanding greatly. Initial efforts to promote such education focussed on the barriers that served as obstacles. These are fairly well documented now, and there is a growing understanding of the range of technical approaches that can be employed to overcome them according to the particular context. Thus, many successful strategies for addressing girls' education are known and have been documented. (excerpt)
Acta Pædiatrica. Supplement. 1999 Aug; 88(430):1-6.The prevalence of breastfeeding varies very much throughout the world. In some countries, such as in Scandinavia, it is extremely high, whereas it is rather low in many industrialized countries such as northern Italy. In urban areas of many developing countries the prevalence is extremely low, although it may be high in rural areas. For instance, in rural Guinea-Bissau in West Africa it is reported to be 100% at 3 mo of age, and this high prevalence may be explained by the fact that infants who have not been breastfed die before this age. In Sweden the prevalence at 2 mo of age was around 95% in 1945 (including infants fed by milk-mothers) but then gradually dropped until 1972, when it was as low as 20%. However, during the following 10-y period the prevalence gradually increased to around 80%. The main reasons for the decline most probably were that infant formulae, then considered to be safe, became available, that an increasing number of women started to work outside their homes, making formula feeding part of the feminist movement, and finally that no real attempts were made to promote breastfeeding in the maternity wards and well-baby clinics. The reverse trend started in 1972, when the attitude towards breastfeeding changed completely. Well-educated mothers became aware of the new discoveries of the importance of breastfeeding from immunological and nutritional points of view, and organized campaigns. Within a few years, the Swedish parliament passed a law which guaranteed all mothers paid leave from their work (80% of their salary) for 9 mo after childbirth, which has now been increased to 12 mo. The WHO/UNICEF code from 1980, which regulates the marketing of infant formula, has also probably played an important role. After a plateau for the prevalence of breastfeeding between 1982 and 1990, a further increase has taken place, particularly between 6 and 9 mo of age. Whereas the first phase in the increase of the prevalence of breastfeeding was, to a certain extent, the result of the concern of well-educated mothers, the second phase (1990-1998) may, at least partly, be explained by the fact that Swedish maternity wards then implemented the suggestion, launched by WHO/UNICEF, to create "baby-friendly" maternity hospitals with the aim of enabling all women to practise exclusive breastfeeding immediately after birth. Methods to stimulate lactation and proper nutritional suckling behaviour of the newborn were then developed. (author's)
Asian Journal of Andrology. 1999 Jun; 1:7-12.The aim was to present a personal account of the involvement of the World Health Organization (WHO) in the collaborative development in Asia of those areas of andrology concerned with male contraception and reproductive health. The andrology training through workshops and institution support undertaken by the WHO Human Reproduction Programme (HRP) and how they contributed to the strengthening of andrology research in Asia are summarised. The author's experience and the Asian scientific contributions to the global research in the following areas are reviewed: the safety of vasectomy and the development of new methods of vas occlusion; gossypol and its failure to become a safe, reversible male antifertility drug; Tripterygium and whether its pure extracts will pass through the appropriate toxicology and phased clinical studies to become acceptable contraceptive drugs; hormonal methods of contraception for men. The WHO policy of research capacity building through training and institution strengthening, together with the collaboration of Asian andrologists, has created strong National institutions now able to direct their own programmes of research in clinical and scientific andrology. (author's)
South African Journal of Demography. 1999; 7(1):63-71.This paper provides a description of demographic resources available on the Internet. These resources include census data, online databases, and home sites of demographic organizations. The description of demographic Internet resources is divided into five sections: North American demography, international demography, general interest items, health-related sources, and geography-related sources. The paper is followed by two appendices. The first provides a brief introduction to the Internet and to Internet access; the second contains a quick-reference list of Internet sites. Readers who are unfamiliar with the Internet should consider reading Appendix I before proceeding. Because one paper cannot reference every demographic resource on the Internet, this paper should be seen primarily as an attempt to impart enough knowledge for readers to seek out further information on their own, according to their particular research interests. (author's)
Reproductions. 1999 Apr; (2): p..India has several Central and State enactment with regard to children. These legislations pertain to guardianship, adoption, maintenance, custody, child labour and other related issues. Despite these enactment, laws enacted to protect children and their rights are repeatedly violated. Politicians are by and large indifferent towards children, as children do not form part of the Vote Bank. Children should be seen as the subject of rights and not as commodities. Society till recently were silent watchers and the main abettors of crime against children. The situation is gradually changing due to international pressure and awareness generated amongst the public with regard to "child rights." It is essential that a child enjoys an environment conducive to healthy growth and development. An abused child is mal-adjusted for the rest of her life. Dr. (Ms.) Sarla Gotala who headed the Indian delegation to the Stockholm World Congress against the commercial sexual exploitation of children held in 1996 has rightly stated: "We must help create an environment for the child particularly the rightly stated: We must help create and environment for the child particularly the girl child, to grow free without fetters." (excerpt)
MCH News. 1999 May; (11):3-5.The care and protection of children is a practice and ethic rooted deep in the wisdom and culture of all societies’, wrote James P Grant, the previous executive director of UNICEF. He was referring to a deep and universal—but often neglected—knowledge that children are vulnerable. Their situation is closely linked to poverty, and more closely related to social inequality than to general economic hardship. Under apartheid, South African children were exposed to gross human rights violations such as detention and shooting. But the less dramatic, more pervasive, violations of apartheid—such as racial exclusion from most of the land and the economy, and discrimination in health care and education—ultimately did more harm. These ‘softer’ violations have left today’s children with an historical disadvantage as a result of social inequity, underdevelopment and poverty. About 61% of South African children live in poverty and, since families with large numbers of children are more likely to be poor, a disproportionate number live in poor households. (excerpt)
MCH News. 1999 May; (11):6-7.All rights apply to all children without exception, and the State must protect children from any form of discrimination. The State must not violate any right, and must take positive action to promote rights. All actions concerning children should take full account of their best interests. The State is to provide adequate care when parents or others responsible fail to do so. The State must translate the rights in the Convention into reality. The State must respect the rights and responsibilities of parents and the wider family to provide guidance appropriate to the child's evolving capacities. (excerpt)
School. School Intervention Impact Model. Version 2.0, December 1999. A tool to estimate the impact of HIV prevention activities focused on youth in school.
London, England, London School of Hygiene and Tropical Medicine, 1999 Dec. 48 p.A collaborative research project between the UNAIDS and the Health Economics and Financing Programme at the London School of Hygiene and Tropical Medicine has been working since 1994 to develop methodologies to determine the costs and likely impact of five HIV prevention strategies - the strengthening of blood transfusion services, condom social marketing projects, school education, the strengthening of sexually transmitted infections (STI) treatment services, and interventions working with sex workers and their clients. 'HIV Tools: a cost-effectiveness toolkit for HIV prevention' is currently being developed. HIV tools consists of: 1) a set of five simulation models that estimate the impact on HIV and STD transmission of different HIV prevention activities; and 2) guidelines for costing different HIV prevention activities. HIV Tools aims to be a flexible and easy to use product, designed for policy makers, programme managers and AIDS Service Organisations working to address HIV and ST1 transmission. It can be used to estimate the impact, cost and cost-effectiveness of different HIV prevention strategies in different settings. (excerpt)
Promoting the participation of indigenous women in World Bank-funded social sector projects: an evaluation study in Mexico. [Promoción de la participación de las mujeres indígenas en los proyectos del sector social fundados por el Banco Mundial: estudio de evaluación en México]
Washington, D.C., International Center for Research on Women [ICRW], Promoting Women in Development [PROWID], 1999. 4 p. (Report-in-Brief; USAID Cooperative Agreement No. FAO-A-00-95-00030-00)Mexico has long been one of the World Bank’s primary clients and is currently its largest cumulative borrower, with loan commitments of up to $5.5 billion approved for 1997-99 (World Bank 1996). During the past 15 years, the focus of the Bank’s lending program in Mexico has shifted away from structural adjustment towards poverty reduction, a strategy that emphasizes investment in health and education. As elsewhere around the world, gender differences in these sectors in Mexico are prevalent with regard to access to and control over resources and decision-making. Given the multiple roles that women play in production, reproduction, child rearing, and household maintenance, social sector projects that target women generate economic and social benefits both for individuals and countries as a whole. Consequently, the Bank has increasingly funded projects that aim to strengthen the participation and position of women in development. The Bank’s publications, official policies, and project guidelines also acknowledge the importance and benefits of promoting women’s roles and empowerment (Women’s Eyes on the World Bank, U.S. 1997; World Bank 1994, 1995, 1997). However, little has been done to evaluate what resources and opportunities are needed to improve the actual standing and participation of women in both Bank-funded programs and society as a whole. While the Bank launched a Gender Action Plan for Central America and Mexico in 1996, this Plan does not clearly define gender impact and assumes that strategies aimed at communities will affect men and women in similar ways. Further, the Bank’s effectiveness in applying its own guidelines on gender and community participation to policy, project design, and implementation on the ground has not been systematically assessed. (excerpt)
Consultative meeting on "Accelerating an AIDS Vaccine for Developing Countries: Issues and Options for the World Bank", Paris, April 13, 1999.
[Unpublished] 1999. 7 p.The World Bank’s AIDS Vaccine Task Force sponsored a meeting at the World Bank European office in Paris on Tuesday, April 13, 1999, to consult with key shareholders, bilateral and multilateral donors, and representatives from developing countries on ways that the World Bank could accelerate the development of an AIDS vaccine that would be effective and affordable in developing countries. The 32 participants included representatives from the North and South, from AIDS control programs, foreign affairs ministries, and ministries of finance, both technical experts and policy makers. An issues paper, “Accelerating an AIDS vaccine for developing countries: Issues and options for the World Bank”, served as background for the meeting. (excerpt)
Consultative meeting on: "Accelerating an AIDS vaccine for developing countries: issues and options for the World Bank", Regent Hotel, Bangkok, Thailand, Monday, May 24, 1999. Report.
[Unpublished] 1999 Jun 29. 10 p.The World Bank’s AIDS Vaccine Task Force sponsored a meeting in Bangkok at the Regent Hotel on Monday, May 24, to consult with key Thai policymakers on ways that the World Bank could accelerate the development of an AIDS vaccine that is effective and affordable in developing countries. The 26 participants included representatives from the Ministry of Public Health, the National Economic and Social Development Board (NESDB), the Government Pharmaceutical Organization (GPO), the Food and Drug Administration (FDA), and private vaccine industry. On Tuesday, May 25, briefings were held for UN agencies and for non-governmental organizations. An issues paper, “Accelerating an AIDS vaccine for developing countries: Issues and options for the World Bank”, served as background for the meeting. (excerpt)
Accelerating an AIDS vaccine for developing countries: issues and options for the World Bank. Revised draft.
[Unpublished] 1999 Jul 8. 18 p.This paper reviews what the AIDS Vaccine Task Force has learned to date about the nature of the problem of under-investment in an HIV/AIDS vaccine for developing countries, and summarizes some of the approaches under consideration. Its objective is to launch a discussion within the World Bank, and – critically – with its bilateral, multilateral, and developing country partners, on the best course of action for the institution, given its mandate, its comparative advantages in relation to the other agencies involved in the international effort, and the likely effectiveness of alternative measures for accelerating the development of an HIV/AIDS vaccine for developing countries. (excerpt)
Preliminary ideas on mechanisms to accelerate the development of an HIV / AIDS vaccine for developing countries.
[Unpublished] 1999 Jul 28. 11 p.The World Bank is fully committed to combat the AIDS epidemic, and has been doing so since 1986 through four fronts: (a) its lending program; (b) its grants program; (c) policy dialogue; and (d) research. Through its lending program, the Bank has financed 81 AIDS projects and project components in 51 countries for a total of US $989 million. Most funding has been through IDA credits. Projects focus on targeted, cost-effective, and efficacious preventive activities, including: information, education and communication (IEC) for behavior change, condom promotion and distribution, sexually transmitted infection (STI) treatment, blood safety, and for the reduction of mother-to-child transmission. Although the focus has been on prevention of HIV infection, some projects also provide treatment for opportunistic infections, tuberculosis, and malaria. Through its Development Grant Facility (DGF), the Bank has provided financing for the WHO Global Programme on AIDS (GPA, the predecessor of UNAIDS) and UNAIDS in the amount of US $18.0 million since FY 1986. The DGF has also contributed to the International AIDS Vaccine Initiative (IAVI), a private, non-profit organization established in 1996 to ensure the development of safe, effective preventive HIV vaccines for use world-wide, contributing a total of US $1.74 million since its inception. The Bank provided an additional US $400,000 to IAVI through the Global Forum for Health. SIDALAC, a Latin American research initiative on HIV/AIDS, received a US $500,000 grant in 1995, and currently receives earmarked funds through UNAIDS of up to US $430,000 per year. And, through its small grants program, the Bank has financed AIDS-related activities in Africa and Asia for a total of US $56,000. (excerpt)
Manila, Philippines, WHO, Regional Office for the Western Pacific, 1999.  p.It is estimated that more than 700 000 people were living with HIV infection in the Western Pacific Region in 1998, with more than 18 000 new AIDS cases occurring in the same year. In contrast, the cumulative number of HIV diagnoses reported in all countries of the Region was about 100 000 and reported AIDS incidence in 1998 was 3300. This reflects a very high level of under-diagnosis and under-reporting of HIV and AIDS cases in the Region. The number of people living with HIV infection is projected to reach 1 million in 2000, and the yearly number of new cases of AIDS to doubled. Analysis of the trend of the relative proportion in HIV risk exposure based on reported cases in the Region suggests that there have been three waves. First, sexual contact among men was the driving force in the early epidemic in Australia and New Zealand, with rapid decrease in prevalence by the late 1980's. Second, the widespread sharing of equipment among injecting drug users (IDUs), primarily in Malaysia, China and Viet Nam was most important during the late 1980s and early 1990s, eventually leveling off around 40% of reported cases (it should be noted that this mode of transmission is probably over-represented due to the mandatory HIV testing of injecting drug users in rehabilitation centres or prison). Finally, the more recent trend has been a steady increase in the proportion of reported cases associated with heterosexual contact. Transmission of the virus through this mode has been gradually increasing since the beginning of the epidemic and is expected to continue to increase in the future. (excerpt)
Sexually transmitted infections prevalence study methodology. Guidelines for the implementation of STI prevalence surveys.
Manila, Philippines, WHO, Regional Office for the Western Pacific, STI, HIV and AIDS Focus, 1999.  p.Screening, diagnosis and treatment costs for many STI are expensive and likely to exceed the per capita health care budget in many countries. A cost effective public health strategy is the adoption of STI syndromic case management. In order to best apply syndromic case management it is important to know the epidemiology of STI in the community. This protocol has been designed to support local STI prevalence studies. The aim of this study is to obtain STI prevalence information and to strengthen the surveillance capacity. In some settings, this study may also contribute to strengthening of research and laboratory capacity. This protocol provides a framework for conducting an STI prevalence study. Generally this type of study attempts to target several population subgroups from within the community who are characterized by different behavioural and risk profiles. Examples of such subgroups are female sex workers, military recruits and pregnant women. Studies of this type are limited in that they do not represent all major population groups and so will not be a true prevalence study of STI pathogens. However, if used within these limitations these studies provide valuable data on the prevalence of selected STI in the studied populations. This data can be used for planning, refining STI case management programmes, and revising disease prevalence estimates for population subgroups. This protocol describes a standardized survey methodology. This protocol uses a simple, reliable and reproducible study design that can be widely used and implemented at the local level. This prevalence study is designed to collect limited basic demographic information and clinical specimens for laboratory testing of STI. To simplify the study protocol, no risk factor or behavioural questions have been included. The principal investigator in each setting should modify the protocol to suit local needs and capacity. (excerpt)