Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine in Papua, Indonesia

NCT ID: NCT05294406

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2023-12-31

Brief 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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IPTp-DP

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.

Group Type: EXPERIMENTAL

Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine

Intervention Type: DRUG

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)

Interventions

Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gadjah Mada University

OTHER

Sponsor Role: collaborator

Indonesia-MoH

OTHER_GOV

Sponsor Role: collaborator

Yayasan Pengembangan Kesehatan dan Masyarakat Papua (Timika Research Facility)

UNKNOWN

Sponsor Role: collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenny Hill, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

LSTM

Locations

Yayasan Pengembangan Kesehatan dan Masyarakat Papua

Timika, Special Region of Papua, Indonesia

Countries

Indonesia

References

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.

Reference Type: DERIVED

PMID: 40874017 (View on PubMed)

Other Identifiers

21-054

Identifier Type: -

Identifier Source: org_study_id