Policy development process for introducing new malaria interventions in Tanzania : the case of Malaria vaccine RTS,S

This thesis describes research into anticipated policy processes and develops a comprehensive framework for informing policy decisions about the RTS,S malaria vaccine in Tanzania. RTS,S is the most advanced of malaria vaccines in development and has shown to protect children 5-17 months when used in conjunction with other malaria control strategies such as insecticides treated nets (ITNs) and anti-malaria drugs. The goal of this study was to analyse the decision making and policy development process for introducing new malaria interventions in Tanzania, without any precedent of malaria vaccine use that might help to understand the context in which a malaria vaccine could be implemented. The goal was pursued using the following methods: a cross-sectional study, a qualitative approach and a synthesis approach. A cross-sectional study of 23 regions of Tanzania conducted during the Tanzanian Integrated Measles Campaign (IMC) survey in 2011 assessed awareness of and willingness to use a malaria vaccine among women aged 18 years or older with children under 11 months old. The main outcome measure was willingness to use a malaria vaccine. Document review and in-depth interviews with 20 key informants were conducted to assess malaria treatment policy changes in Tanzania and in other African RTS,S study countries. A comparative table and framework analysis was used as a practical guide to the steps of the decision making and policy process validated in Tanzania and other African RTS,S study countries. Synthesis and analysis of the results obtained from those studies were used to propose practical recommendations for malaria vaccine implementation. The main findings were as follows: • A high willingness to use the malaria vaccine, associated with a high level of knowledge of the benefits of vaccinating children under-five, high acceptance of the mode of administering the malaria vaccine (2-3 injected doses delivered in the same day according to the proposed schedule for receiving the malaria vaccine). • The framework was developed and applied to RTS, S African countries with regard to its readiness for adoption of the forthcoming malaria vaccine. The rating implies that Tanzania ((12), very good), Burkina Faso ((10), Malawi (9), Kenya and Gabon (8), good) are prepared —with regard to policy promoting factors —to embark on adopting the forthcoming malaria vaccine, RTS, S. Ghana ((5), little) has few policy promoting factors in place and had not yet documented information on barriers to decision making. Mozambique ((1), weak) had hardly documented any promoting factors or barriers. The attempt to compare showed some “good” and “very good” rankings regarding policy promoting factors although these factors may be hindered by some mentioned and documented barriers. According to the findings, implementing the RTS,S malaria vaccine in programme settings still requires guidance in the form of proposed recommendations: In Tanzania, the malaria vaccine is expected to be delivered through Immunization and Vaccine Development (IVD), and implemented at facility level by health care providers in both private and public facilities. In order to support and propagate the policy, a number of activities are recommended. For example, awareness should be created through developing a package of information for the community, the consumers of the vaccine that is accessible and offered in user friendly settings. Different types of media could be used for vaccine adverts and advocacy. A partnership between IVD and Global Alliance on Vaccine Initiative (GAVI) would help to ensure that the vaccine is delivered on time. IVD should strengthen its storage capacity to accommodate the malaria vaccine. To prepare for financing the vaccine, co-financing levels should be incorporated into the national budget. Guidelines, documents and training materials for immunization services should be modified to include the malaria vaccine. Health care personnel involved in vaccination should receive necessary training and a special surveillance system should be established to monitor vaccine pharmacovigilance both at national and district levels. Implementing RTS,S in programme settings still requires some research into: i) assessing the packaging of RTS,S and the storage capacity of IVD to accommodate the malaria vaccine; ii) assessing vaccine pharmacovigilance in low and high transmission settings; iii) identifying the required numbers and skills of human resources iv) determining the additional workload for health care workers involved in vaccination. This is the first report evaluating the policy and decision making process for introducing a malaria vaccine in Tanzania, without any precedent of malaria vaccine use. The results contribute to the growing knowledge that understanding people’s perceptions of a new malaria vaccine and the availability of a comprehension framework to understanding the policy process could speed up the decision making process and shorten the time needed to make the vaccine available to those in need. However, RTS, S vaccine alone does not provide a definitive solution to preventing malaria. The vaccine should be integrated with other strategies to address the burden of malaria in malaria endemic countries in Africa. These findings would be useful for other African countries planning to embark on implementing the RTS,S malaria vaccine when global RTS, S policy recommends its use

Assessment of parental perception of malaria vaccine in Tanzania

Clinical trials of the RTS,S malaria vaccine have completed Phase III and the vaccine is on track for registration. Before making decisions about implementation, it is essential to prepare the ground for introducing the vaccine by assessing awareness and willingness to use malaria vaccines and to provide policy makers with evidence-based information on the best strategies to engage communities to manage the introduction of malaria vaccine in Tanzania.; In November 2011, as part of a large cross-sectional study of all 23 regions of Tanzania (mainland Tanzania and Zanzibar) was conducted during Tanzanian Integrated Measles Campaign (IMC) survey. In this study, the variables of interests were awareness and willingness to use a malaria vaccine. The main outcome measure was willingness to use a malaria vaccine. Logistic regression was used to examine the influence of predictive factors.; A representative sample of 5502 (out of 6210) women, aged 18 years or older and with children under 11 months old, was selected to participate, using random sampling probability. Awareness of the forthcoming malaria vaccine, 11.8 % of participants in mainland Tanzania responded affirmatively, compared to 3.4 % in Zanzibar (p value <0.0001). 94.5 % of all respondents were willing to vaccinate their children against malaria, with a slight difference between mainland Tanzania (94.3 %) and Zanzibar (96.8 %) (p value = 0.0167).; Although mothers had low awareness and high willingness to use malaria vaccine, still availability of malaria vaccine RTS,S will compliment other existing malaria interventions and it will be implemented through the Immunization, Vaccines and Biologicals (IVB) programme (formerly EPI). The information generated from this study can aid policy makers in planning and setting priorities for introducing and implementing the malaria vaccine

Stakeholders' opinions and questions regarding the anticipated malaria vaccine in Tanzania

Within the context of combined interventions, malaria vaccine may provide additional value in malaria prevention. Stakeholders' perspectives are thus critical for informed recommendation of the vaccine in Tanzania. This paper presents the views of stakeholders with regards to malaria vaccine in 12 Tanzanian districts.; Quantitative and qualitative methods were employed. A structured questionnaire was administered to 2123 mothers of under five children. Forty-six in-depth interviews and 12 focus group discussions were conducted with teachers, religious leaders, community health workers, health care professionals, and scientists. Quantitative data analysis involved frequency distributions and cross tabulations using Chi square test to determine the association between malaria vaccine acceptability and independent variables. Qualitative data were analysed thematically.; Overall, 84.2 % of the mothers had perfect acceptance of malaria vaccine. Acceptance varied significantly according to religion, occupation, tribe and region (p < 0.001). Ninety two percent reported that they will accept the malaria vaccine despite the need to continue using insecticide-treated nets (ITNs), while 88.4 % reported that they will accept malaria vaccine even if their children get malaria less often than non-vaccinated children. Qualitative results revealed that the positive opinions towards malaria vaccine were due to a need for additional malaria prevention strategies and expectations that the vaccine will reduce visits to the health facility, deaths, malaria episodes and treatment-related expenses. Vaccine related questions included its side effects, efficacy, protective duration, composition, interaction with other medications, provision schedule, availability to the pregnant women, mode of administration (oral or injection?) and whether a child born of HIV virus or with a chronic illness will be eligible for the vaccine?; Stakeholders had high acceptance and positive opinions towards the combined use of the anticipated malaria vaccine and ITNs, and that their acceptance remains high even when the vaccine may not provide full protection, this is a crucial finding for malaria vaccine policy decisions in Tanzania. An inclusive communication strategy should be designed to address the stakeholders' questions through a process that should engage and be implemented by communities and health care professionals. Social cultural aspects associated with vaccine acceptance should be integrated in the communication strategy

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Additional file 3. Percentage distribution of perceived benefits, mode of administering malaria vaccine and acceptance of proposed schedule. The data provided represent the statistical analysis of benefits, mode of administering malaria vaccine and acceptance of proposed schedule. Majority of women in both Zanzibar and Tanzania mainland understand the benefits of vaccine and they are ready to send their children for vaccination on any proposed schedule. However, women from Tanzania mainland accept the mode of administration (2-3 jabs) more than women in Zanzibar

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Additional file 2. Percentage distribution of perceived awareness and willing to use malaria vaccine. The data provided represent the statistical analysis of awareness and willing to use malaria vaccine. Willingness to use malaria vaccine was higher in both Zanzibar and Tanzania mainland, however, awareness of malaria vaccine was low in the regions, with Zanzibar had the lowest understanding of awareness of malaria vaccine

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Additional file 1. Tool used to collect information on women’s behavioural aspects related to vaccine and malaria Vaccine. The data provided used for analysis of study on “Assessment of parental perception of malaria vaccine in Tanzania: A Case Study”

Stakeholders' opinions and questions regarding the anticipated malaria vaccine in Tanzania

BACKGROUND: Within the context of combined interventions, malaria vaccine may provide additional value in malaria prevention. Stakeholders' perspectives are thus critical for informed recommendation of the vaccine in Tanzania. This paper presents the views of stakeholders with regards to malaria vaccine in 12 Tanzanian districts. METHODS: Quantitative and qualitative methods were employed. A structured questionnaire was administered to 2123 mothers of under five children. Forty-six in-depth interviews and 12 focus group discussions were conducted with teachers, religious leaders, community health workers, health care professionals, and scientists. Quantitative data analysis involved frequency distributions and cross tabulations using Chi square test to determine the association between malaria vaccine acceptability and independent variables. Qualitative data were analysed thematically. RESULTS: Overall, 84.2 % of the mothers had perfect acceptance of malaria vaccine. Acceptance varied significantly according to religion, occupation, tribe and region (p < 0.001). Ninety two percent reported that they will accept the malaria vaccine despite the need to continue using insecticide-treated nets (ITNs), while 88.4 % reported that they will accept malaria vaccine even if their children get malaria less often than non-vaccinated children. Qualitative results revealed that the positive opinions towards malaria vaccine were due to a need for additional malaria prevention strategies and expectations that the vaccine will reduce visits to the health facility, deaths, malaria episodes and treatment-related expenses. Vaccine related questions included its side effects, efficacy, protective duration, composition, interaction with other medications, provision schedule, availability to the pregnant women, mode of administration (oral or injection?) and whether a child born of HIV virus or with a chronic illness will be eligible for the vaccine? CONCLUSION: Stakeholders had high acceptance and positive opinions towards the combined use of the anticipated malaria vaccine and ITNs, and that their acceptance remains high even when the vaccine may not provide full protection, this is a crucial finding for malaria vaccine policy decisions in Tanzania. An inclusive communication strategy should be designed to address the stakeholders' questions through a process that should engage and be implemented by communities and health care professionals. Social cultural aspects associated with vaccine acceptance should be integrated in the communication strategy