Malaria in PregnancyPhase 4STOPMiP-2NCT05294406
Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine in Papua, Indonesia
A Phase 4 study testing Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine in people with Malaria in Pregnancy, run by Liverpool School of Tropical Medicine at 1 site in Indonesia.
Trial summary
Malaria in pregnancy is a major cause of maternal and neonatal death in Papua, Indonesia. A recent trial in Papua showed that monthly intermittent preventive treatment (IPTp) with the long-acting artemisinin-based combination dihydroartemisinin-piperaquine (DP) among pregnant women in the second and third trimester… Read more about this study
- Who is it for?
- Ages 15 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria in Pregnancy
- What is being tested?
- Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,128 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Feb 2022to 31 Dec 2023
- 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 15 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Health facilities (pilot implementation)
- Antenatal services must be operational and accessible
- Midwives/nurses have been trained to prescribe IPTp-DP
- Healthcare providers
- Healthcare providers responsible for providing antenatal care services, and facility managers
- District and provincial health managers
Show all 14Show fewer
- Pregnant women
- Pregnant women aged 15-49 years
- Women in 2nd/3rd trimester of pregnancy
- HIV negative (where status is known)
- Community members
- community leaders
- community health care workers
- husbands of pregnant women
Who cannot join
- Health facilities (pilot implementation)
- Health facilities which have accessibility issues and will not be enrolled in the pilot.
- Healthcare providers
- Health workers providing ANC and IPTp-DP services in health facilities who have provided services for <1 month.
- Pregnant women
- Women with communication or language problems including not being able to speak Indonesian.
- Pregnant women who are unwell during interview
- Pregnant women who move outside the pilot implementation areas.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Yayasan Pengembangan Kesehatan dan Masyarakat Papua
Timika, Special Region of Papua, 99910
About this study
Official title: Evaluation of a Pilot Implementation of Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine to Prevent Adverse Birth Outcomes in Papua, Indonesia
Malaria in pregnancy is a major cause of maternal and neonatal death in Papua, Indonesia. A recent trial in Papua showed that monthly intermittent preventive treatment (IPTp) with the long-acting artemisinin-based combination dihydroartemisinin-piperaquine (DP) among pregnant women in the second and third trimester was safe, tolerable and more efficacious than the current policy of single screening at antenatal care (ANC) booking and treatment of rapid diagnostic test (RDT)-positive cases. The Ministry of Health (MOH) Indonesia now plans to pilot the strategy in the routine health system in Papua, Indonesia. This study will assess the programme effectiveness of IPTp-DP delivery through antenatal care services and women's adherence to the monthly 3-day DP treatment regimen in a 'real life' setting.
The study will be undertaken in ten community health centres in the lowlands and their associated health posts in Timika city. In the first 18 months, MOH will be trained to implement the intervention using quality improvement (QI) approaches to continuously strengthen service delivery, uptake and adherence through plan-do-study-act cycles. The MOH will also be supported to collect safety data for pharmacovigilance. A mixed-methods evaluation will be conducted towards the end of the pilot using exit interviews to assess delivery effectiveness, home visits to assess adherence, and qualitative research to explore provider perceptions of the drivers of successful integration and scalability, and user acceptability. The primary outcome is adherence, defined as the proportion of pregnant women who receive the first dose of IPTp-DP by directly observed therapy (DOT) at ANC, have received the correct number of DP tablets for subsequent doses, and when visited at home have verified they completed the course. The net cost-effectiveness of implementing IPTp-DP and of the current policy of single screening and treatment (SST) in the routine health system will be assessed and compared. Net cost-effectiveness means that cost savings from averted malaria will be deducted from the intervention costs. The incremental financial cost of implementing IPTp-DP from the provider (MOH) perspective at scale in Papua, Indonesia, will also be estimated.
- Conditions
- Malaria in Pregnancy
- Being tested
- Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquineDrug
Pregnant women attending routine antenatal care visits in their second and third trimester are given monthly IPTp consisting of a treatment dose of dihydroartemisinin-piperaquine (3 tablets per day for 3 days, 9 tablets total)
| Study group | Role | What they receive |
|---|---|---|
| IPTp-DP | Experimental | Pregnant women attending routine antenatal care visits in their second and third trimester are given a monthly, presumptive treatment dose of dihydroartemisinin-piperaquine of three tablets daily for three days (9 tablets). The first dose is given by directly observed therapy (DOT), and the remaining doses given to the women to take at home. Receives: Drug: Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence in pregnant women
The proportion of pregnant women who receive the first dose of IPTp-DP by DOT at ANC clinic and have the correct number of DP tablets for subsequent doses on exiting, who when visited at home verify they have completed the treatment (self report and pill counts)
Measured: At study completion, an average of 10 months
Delivery effectiveness
The proportion of women attending ANC clinic treated appropriately according to the IPTp-DP guidelines, defined as the first dose given by directly observed therapy (DOT) on day-1 plus adequate doses to take home for days 2 and 3. Women's understanding of the treatment regimens given during that ANC visit will also be assessed.
Measured: At study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start7 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Gadjah Mada University, Indonesia-MoH, Yayasan Pengembangan Kesehatan dan Masyarakat Papua (Timika Research Facility)
- Responsible party
- Sponsor
- Investigators
- Jenny Hill, MSc, PhD, Principal investigator, LSTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294406
- Sponsor's protocol ID
- 21-054
- Acronym
- STOPMiP-2
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hafidz F, Candrawati F, Hoyt J, Kenangalem E, Dodd J, Lesosky M, Laksanawati IS, Ubra R, Simatupang M, Ter Kuile FO, Worrall E, Poespoprodjo JR, Hill J. Pilot implementation of intermittent preventive treatment with dihydroartemisinin-piperaquine to prevent adverse birth outcomes in Papua, Indonesia: a mixed-method evaluation. Lancet Prim Care. 2025 Jul;1(1):None. doi: 10.1016/j.lanprc.2025.100011.
PubMed 40874017
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Pilot Implementation of Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine to Prevent Adverse Birth Outcomes in Papua, Indonesia
- ClinicalTrials.gov ID
- NCT05294406
- Acronym / sponsor ID
- STOPMiP-2 / 21-054
- Conditions
- Malaria in Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,128 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Gadjah Mada University, Indonesia-MoH, Yayasan Pengembangan Kesehatan dan Masyarakat Papua (Timika Research Facility)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Mar 2022 (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.
Malaria in pregnancy is a major cause of maternal and neonatal death in Papua, Indonesia. A recent trial in Papua showed that monthly intermittent preventive treatment (IPTp) with the long-acting artemisinin-based combination dihydroartemisinin-piperaquine (DP) among pregnant women in the second and third trimester was safe, tolerable and more efficacious than the current policy of single screening at antenatal care (ANC) booking and treatment of rapid diagnostic test (RDT)-positive cases. The Ministry of Health (MOH) Indonesia now plans to pilot the strategy in the routine health system in Papua, Indonesia. This study will assess the programme effectiveness of IPTp-DP delivery through antenatal care services and women's adherence to the monthly 3-day DP treatment regimen in a 'real life' setting.
The study will be undertaken in ten community health centres in the lowlands and their associated health posts in Timika city. In the first 18 months, MOH will be trained to implement the intervention using quality improvement (QI) approaches to continuously strengthen service delivery, uptake and adherence through plan-do-study-act cycles. The MOH will also be supported to collect safety data for pharmacovigilance. A mixed-methods evaluation will be conducted towards the end of the pilot using exit interviews to assess delivery effectiveness, home visits to assess adherence, and qualitative research to explore provider perceptions of the drivers of successful integration and scalability, and user acceptability. The primary outcome is adherence, defined as the proportion of pregnant women who receive the first dose of IPTp-DP by directly observed therapy (DOT) at ANC, have received the correct number of DP tablets for subsequent doses, and when visited at home have verified they completed the course. The net cost-effectiveness of implementing IPTp-DP and of the current policy of single screening and treatment (SST) in the routine health system will be assessed and compared. Net cost-effectiveness means that cost savings from averted malaria will be deducted from the intervention costs. The incremental financial cost of implementing IPTp-DP from the provider (MOH) perspective at scale in Papua, Indonesia, will also be estimated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPTp-DP | Experimental | Drug: Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquinePregnant women attending routine antenatal care visits in their second and third trimester are given a monthly, presumptive treatment dose of dihydroartemisinin-piperaquine of three tablets daily for three days (9 tablets). The first dose is given by directly observed therapy (DOT), and the remaining doses given to the women to take at home. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Health facilities (pilot implementation)
- Antenatal services must be operational and accessible
- Midwives/nurses have been trained to prescribe IPTp-DP
- Healthcare providers
- Healthcare providers responsible for providing antenatal care services, and facility managers
Key exclusion criteria (8 listed)
- Health facilities (pilot implementation)
- Health facilities which have accessibility issues and will not be enrolled in the pilot.
- Healthcare providers
- Health workers providing ANC and IPTp-DP services in health facilities who have provided services for <1 month.
- Pregnant women
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 |
|---|---|---|
| Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquinePregnant women attending routine antenatal care visits in their second and third trimester are given monthly IPTp consisting of a treatment dose of dihydroartemisinin-piperaquine (3 tablets per day for 3 days, 9 tablets total) | Drug | IPTp-DP |
Primary outcome
Adherence in pregnant women
Time frame: At study completion, an average of 10 months
The proportion of pregnant women who receive the first dose of IPTp-DP by DOT at ANC clinic and have the correct number of DP tablets for subsequent doses on exiting, who when visited at home verify they have completed the treatment (self report and pill counts)
Delivery effectiveness
Time frame: At study completion, an average of 10 months
The proportion of women attending ANC clinic treated appropriately according to the IPTp-DP guidelines, defined as the first dose given by directly observed therapy (DOT) on day-1 plus adequate doses to take home for days 2 and 3. Women's understanding of the treatment regimens given during that ANC visit will also be assessed.
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 Mar 2024.
- Derived from this study: PubMed 40874017Hafidz F, Candrawati F, Hoyt J, Kenangalem E, Dodd J, Lesosky M, Laksanawati IS, Ubra R, Simatupang M, Ter Kuile FO, Worrall E, Poespoprodjo JR, Hill J. Pilot implementation of intermittent preventive treatment with dihydroartemisinin-piperaquine to prevent adverse birth outcomes in Papua, Indonesia: a mixed-method evaluation. Lancet Prim Care. 2025 Jul;1(1):None. doi: 10.1016/j.lanprc.2025.100011.
- 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, MSc, PhD principal investigator
LSTM
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 Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine in people with Malaria in Pregnancy, run by Liverpool School of Tropical Medicine at 1 site in Indonesia.
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 14 inclusion and 8 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 Mar 2024. 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 Indonesia. 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: At study completion, an average of 10 months). The study lists 2 primary outcomes in all. 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 NCT05294406, 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 Mar 2024.