Acceptability and Feasibility Principal Investigators:
Dr Jenny Hill and Prof Jayne Webster
Economics, Principal Investigators:
Prof Bjarne Robberstad, Prof Kara Hanson and Silke Fernandes
Co-investigators: Dr Mwayi Madanitsa, Dr Daniel Minja
PhD Student: Dr Matiko Riro
Overview
The current policy of intermittent preventive therapy (IPTp) with sulphadoxine-pyrimethamine (SP involves) a drug that is very cheap, widely available, well tolerated, and relatively simple to deliver as it involves a single course of three tablets that can be given to pregnant women as directly observed therapy (DOT) at scheduled antenatal care (ANC) visits. Replacement of SP with a multi-day artemisinin-based combination therapy (ACT) regimen such as dihydroartemisinin-piperaquine (DP) for IPTp, alone or combined with azithromycin, will be more complicated and costly to deliver than SP and raises uncertainties around patient adherence.
Objective
We will conduct a series of sub-studies alongside the IMPROVE clinical trials to determine whether IPTp with DP, alone or combined with AZ, is a feasible, acceptable and cost-effective alternative to current policy to prevent malaria in HIV-infected and uninfected pregnant women.
Methods in Brief
This is a multidisciplinary, mixed methods study. Acceptability to the two interventions among health providers and pregnant women will be assessed in the trial sites in Kenya, Malawi and Tanzania. Feasibility of implementation will be assessed in the routine health system in adjacent districts to the trial in Kenya (only) to assess the effectiveness of the health system to deliver these interventions and the potential operational hurdles for scale up. We will also assess adherence among pregnant women in this non-trial setting. Collection of cost data will be nested within the feasibility study and combined with the feasibility and efficacy data from the trial through decision modelling to estimate the incremental costs, benefits and cost-effectiveness of the two interventions.
