Clinical trial NCT05294406: Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine in Papua, Indonesia
Official title: Evaluation of a Pilot Implementation of Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine to Prevent Adverse Birth Outcomes in Papua, Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria in Pregnancy
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Gadjah Mada University
name: Indonesia-MoH
name: Yayasan Pengembangan Kesehatan dan Masyarakat Papua (Timika Research Facility)
First posted: 2022-03-24
Enrollment: 2128
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Adherence in pregnant women
timeFrame: At study completion, an average of 10 months
measure: Delivery effectiveness
timeFrame: At study completion, an average of 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Timika
country: Indonesia
facility: Yayasan Pengembangan Kesehatan dan Masyarakat Papua
state: Papua
Study officials:
affiliation: LSTM
name: Jenny Hill, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: