Malaria in PregnancyPhase 4NCT04160026
Acceptability and Feasibility in the Context of the IMPROVE Trial in Kenya
A Phase 4 study testing Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine, Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine and Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer in people with Malaria in Pregnancy and Adherence, Treatment, run by Liverpool School of Tropical Medicine at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria in Pregnancy, Adherence, Treatment
- What is being tested?
- Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine, Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine and Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteKenya
- Study dates
- 11 Nov 2019to 31 Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Feasibility of IPTp With Dihydroartemisinin-piperaquine With or Without Azithromycin to Prevent Malaria, Sexually Transmitted and Reproductive Tract Infections in HIV-uninfected Pregnant Women (IMPROVE) in Kenya.
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).
Read the detailed description
Primary objectives:
- 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.
- 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
- Conditions
- Malaria in Pregnancy, Adherence, Treatment
- Being tested
- 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
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly intermittent preventive treatment with dihydroartemisnin-piperaquineDrug
Also called Dihydroartemisnin- piperaquine -Eurartesim®
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.
Monthly intermittent preventive treatment with sulfadoxine-pyrimethamineDrug
Also called Sulfadoxine-Pyrimethamine, Control Arm
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.
Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transferDrug
Also called Dihydroartemisnin- piperaquine -Eurartesim®, DP Plus
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.
| Study group | Role | What they receive |
|---|---|---|
| IPTp-SP | Active comparator | Arm 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 Receives: Drug: Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine |
| IPTp-DP | Experimental | Arm 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 Receives: Drug: Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine |
| IPTp-DP Plus | Experimental | Arm 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. Receives: Drug: Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed 6-10 months after implementation commences
Secondary outcomes (1)
Effectiveness of service delivery
Proportion of pregnant women attending ANC for their first and second visit in their second or third trimester who receive the drug course correctly on exit from ANC. For IPTp-SP the full dose should be given by DOT.
Measured: Assessed 6-10 months after implementation commences
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start11 Nov 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Kamuzu University of Health Sciences, National Institute for Medical Research, Tanzania, London School of Hygiene and Tropical Medicine, University of Bergen, Kilimanjaro Christian Medical Centre, Tanzania
- Responsible party
- Sponsor
- Investigators
- Jenny Hill, PhD, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160026
- Sponsor's protocol ID
- 18-073
- Status last verified
- Apr 2021
- First submitted
- 7 Nov 2019
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39304238
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of IPTp With Dihydroartemisinin-piperaquine With or Without Azithromycin to Prevent Malaria, Sexually Transmitted and Reproductive Tract Infections in HIV-uninfected Pregnant Women (IMPROVE) in Kenya.
- ClinicalTrials.gov ID
- NCT04160026
- Acronym / sponsor ID
- 18-073
- Conditions
- Malaria in Pregnancy, Adherence, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Kamuzu University of Health Sciences, National Institute for Medical Research, Tanzania, London School of Hygiene and Tropical Medicine, University of Bergen, Kilimanjaro Christian Medical Centre, Tanzania
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| IPTp-SP | Active comparator | Drug: Monthly intermittent preventive treatment with sulfadoxine-pyrimethamineArm 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 | Experimental | Drug: Monthly intermittent preventive treatment with dihydroartemisnin-piperaquineArm 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 | Experimental | Drug: Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transferArm 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monthly intermittent preventive treatment with dihydroartemisnin-piperaquineAlso: Dihydroartemisnin- piperaquine -Eurartesim®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 | IPTp-DP |
| Monthly intermittent preventive treatment with sulfadoxine-pyrimethamineAlso: Sulfadoxine-Pyrimethamine, Control ArmFeasibility 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 | IPTp-SP |
| Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transferAlso: Dihydroartemisnin- piperaquine -Eurartesim®, DP PlusFeasibility 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. | Drug | IPTp-DP Plus |
Primary outcome
Adherence in pregnant women
Time frame: Assessed 6-10 months after implementation commences
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.
1 secondary outcome
Effectiveness of service delivery
Time frame: Assessed 6-10 months after implementation commences
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 39304238Barsosio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Hill, PhD principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine, Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine and Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer in people with Malaria in Pregnancy and Adherence, Treatment, run by Liverpool School of Tropical Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence in pregnant women (time frame: Assessed 6-10 months after implementation commences). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.