Acceptability and Feasibility in the Context of the IMPROVE Trial in Kenya

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).

Conditions

• Malaria in Pregnancy
• Adherence, Treatment

Interventions

DRUG

Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine

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.

DRUG

Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine

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.

DRUG

Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer

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.

Sponsors & Collaborators

• Kenya Medical Research Institute

  collaborator OTHER

• Kamuzu University of Health Sciences

  collaborator OTHER

• National Institute for Medical Research, Tanzania

  collaborator OTHER_GOV

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• University of Bergen

  collaborator OTHER

• Kilimanjaro Christian Medical Centre, Tanzania

  collaborator OTHER

• Liverpool School of Tropical Medicine

  lead OTHER

Principal Investigators

• Jenny Hill, PhD · Liverpool School of Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-11

Primary Completion

2020-07-31

Completion

2020-07-31

Countries

• Kenya

Study Locations