Acceptability and Feasibility in the Context of the IMPROVE Trial in Kenya
Condition: Malaria in Pregnancy; Adherence, Treatment
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This multi-centre study will compare the acceptability, feasibility, cost and incremental
      cost-effectiveness of intermittent preventive treatment (IPTp) with
      dihydroartemisinin-piperaquine (DP) with or without azithromycin to the current strategy of
      IPTp with sulphadoxine-pyrimethamine (SP) to prevent malaria, sexually transmitted and
      reproductive tract infections in HIV-uninfected pregnant women (IMPROVE).
    

Detailed description: 
      Primary objectives:

        1. To assess the acceptability, costs and incremental cost-effectiveness of IPTp-DP, with
           or without AZ, compared to current policy of IPTp-SP in HIV-uninfected pregnant women.

        2. To assess the feasibility of delivering IPTp-DP with or without a targeted information
           transfer intervention among HIV-uninfected pregnant women attending ANC in the routine
           health system i.e. non-trial settings.

      Acceptability, costs and incremental cost-effectiveness will be assessed in the context of
      the IMPROVE clinical trial in Kenya, Malawi and Tanzania (see NCT02909712).

      We will also conduct an 'implementation feasibility' study in the routine setting in adjacent
      sites to the IMPROVE trial site in Kenya (only), using a 3-arm cluster randomized design to
      assess systems effectiveness, implementation strength, scalability, and identify potential
      operational hurdles for scale up. Ministry of health nurses providing routine ANC services
      will be trained to provide IPTp-DP or given refresher training for current policy (IPTp-SP).
      The interventions will be implemented for a period of 10 months. Approximately 5-6 months
      after the start of implementation, delivery effectiveness will be assessed through exit
      interviews with pregnant women leaving ANC clinics. Women who receive the correct doses of
      the interventions will be followed up at home 4-5 days after their clinic visit (i.e. no more
      than 2 days after their 3-day regimen finished) and interviewed about adherence, including
      pill counts. The quantitative study will be supplemented by a qualitative study to explain
      the quantitative outcomes and to assess perceptions of scalability of the interventions
      tested.

      Feasibility study Interventions:

      Monthly IPTp regimens: Arm 1. Standard single-day stat course of quality-assured SP; Arm 2.
      Standard 3-day course of 3 to 5 tablets (40/320mg) of DP per day based on bodyweight
      (Eurartesim®, AlfaSigma, Italy); Arm 3. Same as 2, with additional job aids and IEC
      materials.

      Outcome Measures

      Feasibility study:

      Primary Outcome - Adherence assessed through home visits: Proportion of pregnant women
      attending ANC who receive the first dose of IPTp by DOT and the correct number of tablets for
      subsequent doses (IPTp-DP) visited at home and who have verified they completed the
      treatment. Where IPTp-SP is given by DOT this is assumed as 100% adherence and that the
      correct dosage is given.

      Secondary outcome - Delivery effectiveness assessed by exit interviews with pregnant women
      leaving ANC: Proportion of pregnant women attending ANC for their first and second visit in
      their second or third trimester who receive an appropriate dose with each drug/drug
      combination. For the IPTp-DP arm, women will be asked whether the first dose was given by DOT
      and the correct number of tablets for subsequent doses available on exit. For IPTp-SP the
      full dose should be given by DOT.

      Sample sizes:

      Feasibility exit interviews (delivery rate): 1,485 pregnant women Feasibility home visits
      (adherence rate): 744 pregnant women sampled from women enrolled in exit interviews
      Acceptability among pregnant women: approx. 90 Acceptability among health providers:
      approx.90
    

Intervention name(s): Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine; Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine; Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Feasibility study to assess adherence among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.; Feasibility study to assess adherence among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.; Feasibility study to assess adherence to guidelines among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.
Other intervention name(s): Dihydroartemisnin- piperaquine -Eurartesim®; Sulfadoxine-Pyrimethamine; Control Arm; Dihydroartemisnin- piperaquine -Eurartesim®; DP Plus
Intervention MeSH terms: Pyrimethamine; Piperaquine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The feasibility study is cluster randomised, where a health facility is a cluster.
The acceptability studies are nested within the feasibility study and the IMPROVE clinical trial.
Masking: None (Open Label)
Primary purpose: Prevention