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Yesterday marked the beginning of the study I am currently involved, in as we recruited our first study participant.It has been a long journey getting to this point-one year three weeks to the day when the initial proposal was submitted to the institutional review board and six months since approval by the ethics committee. The study seeks to explore a possible alternative to the current practice of giving sulphadoxine-pyrimethamine to pregnant women on 2 or 3 occasions in order to prevent malaria(SP-IPTp)in areas where malaria incidence is declining and also with the increasing resistance to sulphadoxine-pyrimethamine(SP).
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Dear Doctor Akor, thanks so much for sharing the day to day challenges in your study with us as I believe it is totally the point of this network. Not only will other researchers be encouraged by your own achievements, but I believe with your constant and detailed feedbacks they will feel more confidant to log in, ask questions and look out for answers whenever they face difficulties in their individual sites. Thanks again and please do keep us posted.
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Dear Francis - please tell us how your trial is going?
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Yes Htorres,our site is an experienced site and have been carrying out research in the study area for over 25 years now.The people are familiar with the MRC work and have been very cooperative in several clinical trials conducted here.The husbands usually give their permission when they are aware of the study.This is why community senistisation is important before conducting the trial.This was done extensively in the study area and it involved the key stakeholders-elder,village leaders,women leaders,traditional birth attendants and of course women and men.When they are all aware of what you intend to do it is much easier to get permission from the men and consent from the women.Generally we only consent the women who present at the antenatal clinic,but of course their husbands are aware of the study.We have had a woman call her husband in Europe to seek permission to be part of the study.Whether it is ethically right for an adult woman to seek permission from her husband before making a choice is another issue altogether. But we have to understand the context in which we are doing research as Africans mostly that we do need to consider the cultural sensitivities of our host communities.In some places the husband is the sole decision maker of the family while in others we have seen it is the mother-in-law who makes decision for the family.
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Thank you Francis for sharing the progress of this interesting trial. It is very impressive that you have recruited 200 women in 2 months. You must indeed be an experienced site. Please can you share with us why these ladies did not consent? Do they have to have their husbands permission. We find this often is the case in our trials with rural communities and that is a problem as the husbands are not around. Do you experience this and have you found an ethical way to deal with this?
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The recruitment is going on well.Todat is 2 months since we started and about reaching the 200 mark.We are quite happy with the recruitment rate.Although this is not surprising as the study community is used to our research and have been very cooperative in the past.However we do have refusals for example yesterday we had 9 eligible women but only 2 consented to participate.We have to respect their decision and they continue with their routine antenatal care.We also do follow ups for adverse events relating to the study drug. in a couple of weeks we would be expecting the women to start delivering and reach the end point of the study.
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Hello Francis. I enjoyed hearing about your new trial. Congratulations, the set up is always such a long process. Please do tell us how you are getting on now? How is it going - how is the recruitment?
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We are using the WHO recommended SP(sulphadoxine-pyremethamine).
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Good luck, Francis! Do keep us up to date. We had a study too, and follow up was quite challenging. I hope its easier for you as your population is pregnat women. What drugs are you using?