Acceptability, feasibility and economic studies in the context of the Improve & improve - 2 trials (MPROVE-ACCEPT)

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Date
2020-01-28
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Kamuzu University of Health Sciences
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Title: Acceptability, feasibility, cost and incremental cost-effectiveness of IPTp with dihydroartemisininpiperaquine with or without azithromycin to prevent malaria, sexually transmitted and reproductive tract infections in HIV-uninfected pregnant women (IMPROVE) and HIV-infected women receiving daily CTX (IMPROVE-2 Kenya and Malawi only) in Kenya, Malawi and Tanzania. Short Title: Acceptability, feasibility and economic studies in the context of the IMPROVE & IMPROVE- 2 trials Type of study: Qualitative study employing in-depth interviews and focus group discussions to understand acceptability of IPTp+DP or or without AZ with HIV-uninfected women and HIV-infected women receiving CTX. Problem: Malaria in pregnancy can have devastating consequences for the mother and foetus. Pregnant women are often infected with malaria without showing any outward signs or symptoms which, if left undetected and untreated, can cause anaemia and interfere with the development of the foetus leading to loss of the pregnancy, or premature birth and low birth weight, which in turn increases the risk of early infant death. The World Health Organisation (WHO) therefore recommends a preventive strategy called ‘intermittent preventive treatment in pregnancy’ (IPTp) in which mothers receive a single dose of 3 tablets of medication called sulphadoxine-pyrimethamine (SP) at each scheduled antenatal visit starting in the 2nd and 3rd trimester. However, the effectiveness of this strategy is being compromised due to high levels of resistance to SP in the malaria parasite population in many parts of sub-Saharan Africa. The IMPROVE trials aim to evaluate alternative drugs for the prevention of malaria in both HIV-uninfected (IMPROVE-1) and HIV-infected (IMPROVE-2) pregnant women. The trials will compare the safety, tolerance and beneficial effects of IPTp with DP alone, or combined with azithromycin, to the current strategy with sulphadoxine- pyrimethamine in reducing pregnancy loss, low birthweight, preterm birth and small-for-gestational- age babies, and early infant deaths. In parallel to the trials, we will conduct a series of studies to explore the feasibility, acceptability, cost and cost effectiveness of these two interventions in comparison to the current strategy. Aims and objectives This multi-centre study will enrol about 2,300 pregnant women in Kenya, Tanzania and Malawi and compare the acceptability, feasibility and ‘costs vs benefits’ of IPTp with DP alone, or combined with azithromycin, to the current strategy with sulphadoxine- pyrimethamine. Methods in Brief This is a mixed methods study using a range of quantitative and qualitative techniques. Acceptability among health providers and pregnant women to the two interventions will be assessed by interviewing pregnant women and health providers participating in the trial sites in Kenya, Malawi and Tanzania. In Malawi, only the qualitative techniques to understand acceptability of the interventions will be assessed. Feasibility of implementation will be assessed by delivering the interventions through the routine health system in adjacent sites to the trial in Kenya (only) over a period of 10 months, followed by an evaluation to assess the effectiveness of the health system to deliver the interventions and potential operational hurdles for scale up. Uptake and adherence among pregnant women attending antenatal clinics will be assessed by interviewing women as they leave a health facility and again followed-up at home. Health providers will be interviewed to explore their perceptions and experiences with the new regimens to assess scalability. Collection of cost data will be nested within the feasibility study and the trials and combined with feasibility and data from the trial and use modelling to estimate the incremental costs, benefits and cost-effectiveness of the two interventions compared to IPTp-SP in HIV negative or compared to cotrimoxazole only in HIV positive women. Expected findings: Evidence from qualitative studies in Malawi will provide clarity and useful information on issues around acceptability lity of the delivery and administration of the intervientions so that health care providers and policy makers can make evidence-based decisions on the opportunities and challenges that must be considered when planning for change. Dissemination: Results from this research activity will be disseminated at the CoM Research Dissemination Conference and to specific interest groups, both in meetings / workshops and through conferences, nationally and internationally; and through journal article[s]. Final publications will be shared with COMREC
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