Plenary Presentations
The opening plenary began with presentations on the current status of ITM programs: a review of bednet trials and the experience of ITMs in Africa.* Five additional presentations were given on the four conference themes: demand, access, affordability, and appropriate use. Following the plenary, the conference divided into small work groups to consider the themes in depth and to relate them to the programming process. Chapter III summarizes the main output of the work groups; this Chapter summarizes the formal presentations.
Review of Bednet Trials:
Mosquito nets are not a new idea since they have been used for thousands of years already, but the idea to combine them with a residual insecticide goes back to World War II. In the late 1970s, pyrethroids, which are safe for home use, became available, and they made it possible to envisage widespread use of the treated materials.
In the 1980s, ITMs were put through a series of successive testing phases, comparable to the development of other health interventions. Phase 1 studies confirmed the safety of ITMs and their impact on vector insects.
Phase 2 trials were small-scale trials often focusing more on the entomological than on the disease impact. Finally, Phase 3 clinical trials were started in the mid-1980s to assess impact on malaria at the community level.
In all these trials the safety and side-effects of ITM were always assessed as well. In the late 1980s, a first trial in The Gambia demonstrated a substantial impact on all-cause child mortality. This encouraging result led WHO/TDR to launch and support four additional large-scale trials with mortality as the primary outcome (in The Gambia, Burkina Faso, Ghana, and Kenya).
With the results of these trials being available, it is now time to move on to Phase 4 with work on the effectiveness of ITMs (as opposed to their efficacy) and their long-term impact. The crucial area of operationalization and operational research is also becoming a major focus for implementation and research.
The current review of all Phase 3 trials has been carried out using the standardized methodological criteria of the Cochrane Collaboration, a large international initiative aiming at reviewing the effects of health care interventions. Bednets and curtains were lumped together as "nets," and no distinction was made between the different pyrethroid insecticides. However, the analysis has been stratified according to the type of control group (either no nets or untreated nets). Results were further separated into areas with stable malaria transmission (Entomological Inoculation Rate - EIR < 1, essentially Africa and Papua New Guinea) and areas with unstable transmission (EIR < 1, rest of Asia and Latin America).
For the latter group, results were divided into impact against P. falciparum and P. vivax. Trial outcomes included essentially impact on all-cause child mortality and incidence of clinical malaria episodes. All trials except one assessed impact under trial conditions (efficacy) rather than under program (Areal world@) conditions (effectiveness). The data for this review are detailed on the CD-ROM of the Cochrane Collaboration (Reference: C. Lengeler, Insecticide-treated bednets and curtains for malaria control. The Cochrane Library, Oxford, Update software, 1998).
Figure 1 summarizes the results of the five trials with overall mortality as the main outcome. Four trials were randomized and controlled while the first trial in The Gambia (Alonso et al.) was not randomized. In the two Gambian trials, the control group used untreated nets, while the intervention group had their nets treated. In the three other countries, the control group did not have any net. In the trial settings, there was a wide range of transmission, and the relative protective efficacy (calculated as the percentage of mortality reduction) clearly decreased with increasing malaria transmission.
As a result of this decrease there has been some discussion as to whether the reductions in mortality achieved in Ghana and especially in Burkina Faso were sufficient to justify the large resources needed to implement an ITM program. This question can be answered by looking at the absolute reduction in mortality, as given by the rate difference; this shows directly the number of deaths that can be avoided per year for every 1,000 children protected by ITMs. It is apparent from Figure 1 that the absolute impact is rather similar in the four later trials, while it is much higher (over 17 deaths avoided per year per 1,000 children protected) in the first Gambian trial.
This apparent paradox is essentially explained by the fact that mortality increases strongly with increasing transmission (as can be seen from the rates in the control group). Summing the available data shows that overall there is a reduction of 19% in child mortality. This translates into 5.6 deaths averted per year and per 1000 children protected (Figure 2).
The impact of ITMs on the incidence of clinical episodes of malaria is shown in Figure 3 (control group: no nets) and in Figure 4 (control group: untreated nets). For stable malaria areas, treated nets work very well. In Africa there was a 46% (controls: no nets) and 37% (control group: untreated nets) reduction in the number of clinical episodes. In Asia and Latin America there was a 60% and 33% reduction against P. falciparum and a 45% and 14% reduction against P. vivax. To some extent, the difference in the results between the two groups of controls shows the impact of untreated nets on their own.
The results presented above document the high public health benefits of ITMs and call for their rapid implementation on a large scale in malarious areas.
Two main research issues remain currently:
The impact of ITMs under program (Areal-life") conditions as opposed to scientific trials
The long-term impact of ITMs in areas of very high transmission (EIR>100) because of the problem of delayed acquisition of immunity. No hard data exist currently on this question, and programs implemented in such zones should include a good monitoring component. However, on the basis of current evidence there is no reason for halting the implementation of ITM programs.
Four conclusions can be drawn from this review of insecticide-treated net trials:
TMs have a substantial impact on child mortality in Africa (5.6 deaths averted per 1,000 protected children per year). With 80 million children under age five in Africa, 400,000 deaths could be saved
The relative impact seems to decrease with increasing transmission (from 29% to 14 %) but this effect is not seen with absolute impact
ITMs have a substantial impact on mild disease episodes, with nearly a halving of clinical episodes in Africa
The impact within programs and long-term effects still need to be assessed.
Overview of Bednet Experience in Africa: Summary of the Presentation by Deogratias Barakamfitrye (WHO)
Case fatality rates for malaria are as high as 40% in some places. Malaria causes 1.5 to 2.7 million deaths per year. Seventy-three percent of the population lives in malaria endemic areas; 18 % in epidemic-prone areas. Malaria is responsible for $1.7 to 2 billion in economic losses every year.
ITMs are one of five components of the Regional Malaria Control Strategy:
Case management Personal protection (ITMs) Epidemic forecasting, early detection, and control Monitoring, evaluation, and operational research Integration of activities within primary health care. Malaria control plays a key role among African public health initiatives. It is part of child survival and integrated management of childhood illnesses. There the challenge is to improve care-seeking behavior for fever, improve home management of fever, improve compliance with malaria treatment, and promote the use of ITMs. Malaria control is also part of efforts to control emerging and re-emerging infections. Anti-microbial resistance-the decreasing efficacy of drugs-and the small number of new drugs are serious problems.
Successful prevention through the use of ITMs could decrease demand for drugs and perhaps slow development of resistance, if associated with appropriate treatment and compliance. Finally, malaria control is related to the promotion of safe motherhood. Chemoprophylaxis and use of ITMs are recommended for pregnant women.
Experience with the use of bednets is limited in Africa. Gambia is the only country in which ITMs have been used on a wide scale. Other projects are pilots or small-scale. Of the 42 malaria endemic countries, 25 are promoting the use of ITMs, but coverage is low. ITMs are expensive and not widely available. Because experience is limited, we still don't know if ITMs are effective in all settings and if they reduce mortality or shift it (or both).
The challenge is to make the transition from efficacy trials to sustainable community-based interventions. This will require that ITMs be available, affordable, and acceptable to potential users. Above all, it is necessary to carefully monitor the resistance of the vectors to insecticides used on ITMs. Hopefully, this conference will be the beginning of a strong public-private partnership to address malaria, the most important killer in Africa.
Conference Themes
Demand Creation: Summary of the Presentations by Marcia Griffith (The Manoff Group) and John Berman (Population Services International)Marcia Griffith
As we move from efficacy trials to programs, an important issue is creating demand for insecticides and netting. What is demand creation? Our overall goal is to create a culture of ITM use, like the culture of breastfeeding. If demand creation has been successful, people will (1) try an ITM and (2) continue to use it, and (3) use will spread until all participate equably in an ITM culture.
Creating demand focuses on consumers or potential consumers. Their needs and desires must be recognized, understood, and catered to. When it is successful, demand creation enhances the effectiveness and cost-effectiveness of programs. Money and effort spent on infrastructure-in this case on supply of nets and insecticides-without providing for effective demand may be wasted. Trial and sustained use are driven by both supply and demand.
The two basic elements of demand creation are formative research (or market research) and communications. Experts in these two areas can provide ITM programs with a creative spark and can think strategically.
Formative research is consumer-based research. It should be conducted before programs are designed. It allows epidemiologic needs to be balanced with consumer needs, clarifies trade-offs in consumers- minds, and provides information for a host of decisions. Among these are decisions on consumer differences/audience segments, characteristics and price of the product, the best private/public mix for the market and delivery strategy, and the most appropriate communication strategy.
Research will provide information on people's perceptions and beliefs about mosquitoes, malaria (how they define the disease), control mechanisms and trade-offs, and insecticides, as well as their use of preventive measures and cultural norms, such as sleeping patterns. Research will also help planners to understand the nature of people's contact with commercial markets, communications media, and public and community programs related to malaria control.
The techniques of formative research are usually qualitative. They include in-depth interviews, focus group discussions, and user-non-user comparisons. TIPs (trials of improved products) can provide a wealth of information.
When formative research is complete, a communications strategy can be designed. Such a strategy should attempt to (1) remove resistance to taking the desired action and (2) heighten motivation for taking action. Consumers should be provided with information about the product and treatment and proper use. Communication strategies can also be directed at the policy level, to advocate for ITMs with public and private leaders.
In the demand creation cycle, the consumer informs decisions on the product, delivery, pricing, and proper use and then communication disseminates these decisions. This cycle must repeat itself as experience is gained and as the program moves from the trial stage to sustained use.
John Berman
National-level issues include knowledge of other demand-creation programs (are their messages compatible with the proposed program?), level of donor and government support, and information about the registration process for the insecticide, including how long it will take, or verification that the insecticide has been registered. Finally, information is needed on private sector involvement: who are the vendors, what volume do they operate at, what are their prices, what is the source of their goods, are they subject to taxes and other duties?
Rather than using one approach exclusively, it is wise to strive for a mix.
It is also wise to strive for a mix when deciding whether to create demand for malaria control on the one hand or a good night's sleep on the other. It does not have to be an either-or proposition. If consumers understand the transmission mechanism and the way in which treated nets can limit transmission, they may be more likely to buy and treat nets for themselves and their children. If consumers value a good night's sleep, and if a treated net reduces biting, this will also motivate them to buy and treat nets. However, the good-night's-sleep motivation might not lead to nets being used for children.
There are pros and cons for the two basic approaches to creating demand: mass media versus interpersonal communication, as shown in Box 2-1 below: (below.)
Box 2-1: Two Approaches to Creating Demand
| Mass Media | Interpersonal |
|
PROS
everyone hears the same radio spot. | PROS
(question and answer). CONS |
Demand creation experience in other areas, particularly family planning and HIV/AIDS, can be relevant to ITMs. The principles of the process are the same: identification of a target market, development of a message strategy to motivate the target market, and use of a wide range of communications channels.
Experience with large-scale commercial ITM social marketing programs is extremely limited. It may be too early for "lessons learned." However, we do know that in areas where there are significant levels of nuisance bites, selling bednets at reasonable prices is easy. We also know that the transition from free dipping to cost recovery can be difficult. We need more experience. We need to start new and scale up existing operational programs in order to gain experience with demand creation for and distribution of nets and insecticide treated materials.
Accessibility:Summary of the Presentation by Trevor Penhallrick (Group Africa)
The following description of the distribution chain in sub-Saharan Africa is based on information about Nigeria, Uganda, Kenya, Tanzania, Zambia, Malawi, and Zimbabwe, all Anglophone countries in the malaria zone. The population in these countries is still largely rural, as shown in Figure 5. A large percentage of the population subsists on less than one U.S. dollar per day, as shown below:| Nigeria 28.9% Kenya 50.2% Uganda 50% Zambia 84.6% Zimbabwe 41% (No data are available for Tanzania and Malawi.) |
There are few buses and trucks per 1,000 people compared with developed-country levels. There are 223 buses and trucks per 1,000 people in the United States and about 36 in Germany. The number of buses and trucks per 1,000 people for the seven countries ranges from 1.1 for Uganda to 7.4 for Zambia. The same discrepancy exists in railroad miles per 100 people. In Germany there are 6.95 miles per 100 people; in the United States 5.13. The range for the seven sub-Saharan countries is from .21 miles for Nigeria to 1.49 for Zimbabwe. Miles of railroad per 100 square miles range from .3 in Zambia to 1.3 in Malawi, compared with 4.2 in Germany and 38 in the United States. Miles of road per square mile range from .08 in Zambia to .37 for Zimbabwe, compared with 2.9 in Germany and 1.1 in the United States. But in Africa only a fraction of the roads are paved: 28% in Nigeria (the highest) down to 4% in Tanzania. In Germany 99% of the roads are paved; in the United States, 89%.
Figure 6 shows the channels of distribution in developed countries. Essentially the flow is from manufacturer or importer to wholesaler, retailer, and finally consumer. In some instances agents, sales representatives, and storage depots may be involved. For perishables the process may be short-circuited.
"Looking at distribution channels in Africa the conclusion is: there is a system and it works. If it ain't broke, don't fix it."
Trevor Penhallrick
This distribution plan can be affected by local conditions and may have to be adjusted. Factors as diverse as perceived standards of response, precision, consistency, urgency, competition, service, and communication will impact the distribution plan.
In adjusting the paradigm for Africa, issues around service and communication do confront us. These include:
The administrative process of getting goods Finance-largely on a cash basis Bureaucracy-some countries are looking for ways to reduce bureaucracy Security-many people are poor and tempted to pilfer Physical movement of goods Who moves the goods The profile of grocery products The profile of retail distribution The photographs demonstrate how goods are moved in Africa.[see additonal photos]
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Numerous methods of moving goods are shown: a truck with a tarpaulin, a brand-name truck moving product out by going around the distribution chain, people moving goods on carts or on their heads, and buses used to carry many products.
In essence they show that the channels of distribution in Africa are the same as everywhere else, except for the addition of hawker, as shown in Figure 7 below. There is a system and it works; don't tamper with it. But be aware of outstanding issues:
Channels of Distribution In Africa
Channels of Distribution in Africa
Availability (supply chain support) Affordability of product and distribution Acceptability (product must be relevant to the communities).
Affordability:
Affordability is a key aspect of a successful ITM program. Demand and availability are necessary elements, but they are not sufficient for success. If people cannot afford the nets and insecticides, then the program won't succeed.
People must have the means to purchase them and must regard them as a household priority. However, we should not create a situation in which people switch resources needed for food or other essentials so that they can obtain bednets. Subsidies may be used, but if ITM use is to be sustainable, people must pay a substantial amount toward nets and insecticides.
If bednets are not affordable, alternative materials could be impregnated with insecticides-curtains, for example. Perhaps a transition phase is needed in which programs begin with insecticides, not with bednets.
Benefits to be expected from use of ITMs are reductions in mortality, in time lost from work, in treatment costs, in expenditures on prevention, in funeral expenditures, and in pressure on drugs and development of drug resistance. ITMs may also reduce head lice and offer some protection from snakes.
A reasonable estimate of the cost of a large-scale ITM program is based on the following assumptions:
Country of 12 million people
Average of 3 people per bed
Cost of net = $4 (excluding local distribution)
Useful life of net = 4 years
Nets dipped twice a year
Annual cost of dipping = $0.50
Nets introduced over 4 years.
Thus, the cost of the program may be calculated:
4 million nets would be required Cost of nets for first year (1 million X $4) = $4 million Cost of dipping nets (4 million X $0.50 X twice a year) = $2 million Total cost = $6 million Annual per capita cost ($6 million ) 12 million) = $0.50. In addition, local distribution costs, including profit, must be added. (In Tanzania, adding these costs increased the cost of the net from $3.60-$4.20 to $5.40-$6.40.)
Setting prices is a difficult task, one in which a number of factors should be considered. The objectives of the program will definitely come into play, particularly in decisions about subsidies. In addition, consideration must be given to the amount people are able and willing to pay (this is often quite a lot), the sensitivity of demand to price changes, access to other sources of funds that can be used for subsidies, and the effect of pricing (and subsidies) on long-term sustainability and equity.
The product may have to be distributed initially for free so that people can see its value; subsequently people will have to pay. This was done in Gambia. When people had to pay, there was an initial drop in the number of ITMs distributed, but the number gradually increased.
Affordability may be assessed through market and user surveys, household expenditure surveys, and willingness-to-pay studies, although the latter may be difficult to conduct for a new product whose use and benefits people don't understand. In making these assessments, seasonality of cash availability must be taken into consideration. Often cash is low at the peak mosquito season. Other considerations include household responsibilities for purchasing goods, size of households and sleeping patterns, household expenditure priorities, and the availability of credit schemes or other payment options.
A subsidy is an artificial incentive for lowering the cost of a good. Subsidies can help assure that the nets are being used by targeted groups, but they also have the potential to reduce the customer base for commercial sales.
Payment options can make it more feasible for a family to afford ITMs. Payment may be in-kind rather than cash. Credit schemes or pre-payment plans can also be used.
Several lessons about affordability can be drawn from the experience in Gambia and Senegal. In Gambia, there was a substantial decline in dipping after charges were introduced (from 80+% to 16%, depending on the community). More recent data show that, in villages where insecticide was available, 45% of the women using bednets with one or more children under five had treated their nets. Availability was the problem: a move away from dipping days to open dipping increased the dipping rate. In Senegal, after charges were introduced for dipping ($0.80 for cotton and $0.40 for nylon nets), treatment fell by two-thirds. Moving from subsidy to cost-recovery eroded good will.
The following year, an experiment was conducted in three villages. In the first, people paid full price when they dipped; there the dipping rate was 40%. In the second, people paid the full price, but payment was delayed; there the dipping rate was 75%. In the third, the dipping price was subsidized so that people paid only $0.10 per net; in this case the dipping rate was 80%. (Source for Senegal data: Giancarlo, 1990)
Aside from subsidies, other options exist for reducing costs. Planners of ITM programs should explore alternatives for reducing costs through purchasing in bulk and warehousing and through improved manufacturing, packaging and distribution.
The challenge is to ensure that ITMs are widely used throughout sub-Saharan Africa, especially by those at greatest risk of developing malaria, and that the available resources for malaria control are used as wisely as possible.
Appropriate Use:
The aim of this conference is to develop ITM strategies for the real world. The days of controlled trials of ITM efficacy are over-where most of the inhabitants of a village would use impregnated nets because they were given them without charge. The search now is for sustainable solutions. This means that target populations will have to make the effort to procure nets, curtains, dipping, and re-dipping for themselves. Whatever the type of program (health service based, NGO supported, commercial venture, etc.), people will have to go to a lot of trouble to get and maintain ITMs.
Buying or getting nets and curtains, maintaining them, washing them, getting them dipped and re-dipped will require not only time and money, but also a lot of determination. If people cannot be offered something that they can use easily and effectively, that is available, affordable and attractive, the ITM program will fail. In other words, instead of trying to bend people's behaviors to fit technologies, the technologies should be bent to fit people's behavior.
The consumer's point of view must be at the heart of ITM program planning. The main message is to give people what they want.
Health programs often mistakenly think that the health argument is the one that persuades people. This is not necessarily the case. Are ITMs used appropriately for malaria prevention, or can other uses also be "appropriate"? In Burkina Faso, where I work, we asked customers why they obtained a net. Most people mentioned a good night's sleep: no one mentioned malaria. People spent a lot of money on mosquito coils to prevent nuisance bites. This suggests that people want protection from mosquitoes.
When people were questioned about malaria, they identified five types: they believed that each type had a different cause. Examples of causes were getting cold or soaked by rain, drinking bad local beer, eating greasy food, working under a hot sun, and being bitten by a mosquito. Serious malaria was caused by a spell from a sorcerer. A child may get a fever-a non-malarial fever-even if he or she sleeps under a net. The people might not know that it is non-malarial. These local understandings of malaria must be taken into consideration when designing programs.
Other socio-cultural factors include how late people stay up (are they under the nets when mosquitoes are biting?), whether or not they use the nets when it is too hot, places people sleep (do they sleep outside?), and so on. In Tanzania, when focus groups were asked why they couldn't sleep under nets in the fields, they explained that they wouldn't be able to get out from under the nets fast enough to head off the pigs from stealing the crops.
A household survey in Burkina Faso revealed that only 20% had netsCmost were full of holes, and they were too expensive to replace. However, 80% had curtains. Then there is the problem of lack of a bed. It appears crazy to buy a bednet unless one has a bed, in most instances. Yet in some countries, people use nets with mats on the floor. Net washing also presents a problem. Women were asked not to wash their ITMs, but most women washed them anyway because they were dirty.
These examples are given to underline the point that ITM programs must start with use, not demand. It must be ascertained what potential customers want and know and like. Technology must be fitted to people. What people think and do is not the problem. The problem is that the so-called solutions don't take into consideration what people think and do. What people think and do should be viewed as an opportunity.
If ITMs are to"take off" and be adopted on a large scale by populations at risk
of malaria in the 21st century, the only way to succeed is to put people at the heart of our activities. This requires turning programs inside out. Instead of trying to solve our problem (reduce malaria prevalence) we have to find ways to solve the users' problems. Instead of using our medical logic, we have to find out about the logic of ordinary people's lives. Instead of trying to force a new idea on people, we have to understand how to offer them something that they are going to want so much that they will be prepared to go out and get it.
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