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

• Status: Completed
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Liverpool School of Tropical Medicine
• Collaborators: Kenya Medical Research Institute; Kilimanjaro Christian Medical Centre, Tanzania; London School of Hygiene and Tropical Medicine; National Institute for Medical Research, Tanzania; University of Bergen; University of Malawi College of Medicine
• Treatments: Fanasil, pyrimethamine drug combination; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Kenya Government owned health facilities, Level 3 or 4 health facilities

• Pregnant women attending ANC through non-trial health facilities for a scheduled antenatal care visit in the second or third trimester who receive one of the three study interventions depending on which arm is allocated to that health facility

Exclusion Criteria:

• Mission or private health facilities, Kenya government owned Level 2 or level 5 health facilities, health facilities included in the trial

• Pregnant women accessing private health facilities

• Health facilities, or pregnant women, involved in other malaria or HIV in pregnancy intervention trials or studies.

• Pregnant women in the first trimester, or pregnant women for who their last visit was less than one month ago