Acceptability and Feasibility in the Context of the IMPROVE Trial in Kenya
1 other identifier
interventional
1,600
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedStudy Start
First participant enrolled
November 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedApril 15, 2021
April 1, 2021
9 months
November 7, 2019
April 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence in pregnant women
Proportion of pregnant women attending ANC who receive the drug course correctly and who have verified they completed the treatment at home during a home visit.
Assessed 6-10 months after implementation commences
Secondary Outcomes (1)
Effectiveness of service delivery
Assessed 6-10 months after implementation commences
Study Arms (3)
IPTp-SP
ACTIVE COMPARATORArm 1. Standard single-day stat course of quality-assured SP (Fansidar ®) of 3 tablets (500 mg of sulphadoxine and 25 mg of pyrimethamine). SP given monthly
IPTp-DP
EXPERIMENTALArm 2. Standard 3-day course of 3 to 5 tablets (40/320mg) of DP per day based on bodyweight (Eurartesim®, AlfaSigma, Italy). DP given monthly
IPTp-DP Plus
EXPERIMENTALArm 3. Standard 3-day course of 3 to 5 tablets (40/320mg) of DP per day based on bodyweight (Eurartesim®, AlfaSigma, Italy) plus targeted information for health providers.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liverpool School of Tropical Medicinelead
- Kenya Medical Research Institutecollaborator
- Kamuzu University of Health Sciencescollaborator
- National Institute for Medical Research, Tanzaniacollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- University of Bergencollaborator
- Kilimanjaro Christian Medical Centre, Tanzaniacollaborator
Study Sites (1)
Kenya Medical Research Institute
Kisumu, 40100, Kenya
Related Publications (1)
Barsosio HC, Webster J, Omiti F, K'Oloo A, Odero IA, Ojuok MA, Odiwa D, Omondi B, Okello E, Dodd J, Taegtmeyer M, Kuile FOT, Lesosky M, Kariuki S, Hill J. Delivery effectiveness of and adherence to intermittent preventive treatment for malaria in pregnancy with dihydroartemisinin-piperaquine with or without targeted information transfer or sulfadoxine-pyrimethamine in western Kenya: a three-armed, pragmatic, open-label, cluster-randomised trial. Lancet Glob Health. 2024 Oct;12(10):e1660-e1672. doi: 10.1016/S2214-109X(24)00261-4.
PMID: 39304238DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jenny Hill, PhD
Liverpool School of Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The feasibility study in the routine setting was not masked, this was a 3-arm study where interventions were delivered by ministry of health staff. The acceptability study was nested in the clinical trial which was a 3-arm placebo controlled multicentre trial (see NCT02909712) .
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 12, 2019
Study Start
November 11, 2019
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
April 15, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share