Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine in Papua, Indonesia (STOPMiP-2)

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.

Study Overview

• Status: Completed
• Conditions: Malaria in Pregnancy
• Intervention / Treatment: Drug: Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine

• Study Type: Interventional
• Enrollment (Actual): 2128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Papua
    • Timika, Papua, Indonesia, 99910
      • Yayasan Pengembangan Kesehatan dan Masyarakat Papua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	At study completion, an average of 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At study completion, an average of 10 months

Collaborators and Investigators

• Sponsor: Liverpool School of Tropical Medicine
• Collaborators: Indonesia-MoH; Gadjah Mada University; Yayasan Pengembangan Kesehatan dan Masyarakat Papua (Timika Research Facility)
• Investigators: Principal Investigator: Jenny Hill, MSc, PhD, LSTM

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Mosquito-Borne Diseases; Malaria; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Piperaquine; Artenimol
• Other Study ID Numbers: 21-054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No