Feasibility and Acceptability of Butterfly iQ

NCT ID: NCT05054504

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1575 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2024-03-15

Brief Summary

The purpose of this study is to investigate feasibility and acceptability of a novel intervention to integrate Butterfly IQ into antenatal care (ANC) service delivery in Malawi. The study will also explore potential impact of the intervention on selected service delivery outcomes and identification of abnormal pregnancies.

Detailed Description

The purpose of this study is to investigate the feasibility and acceptability of a novel intervention to integrate Butterfly IQ into ANC service delivery in Blantyre, Malawi. This study will further the understanding of antenatal ultrasound in Malawi by testing the following hypothesis:

When planned and implemented collaboratively with local stakeholders, limited introduction and integration of point-of-care ultrasound with Butterfly iQ into ANC service delivery at health center level will be feasible and acceptable for health providers and clients.

The study intervention will include a multi-phased approach to design, introduction, improvement, and evaluation of Butterfly IQ for routine obstetric ultrasound integrated into ANC service delivery in Malawi.

Phase 1: Training Phase 1 includes training on Butterfly IQ, integration in ANC workflow, and referral/counter-referral within network.

Phase 2: Iterative Service Delivery Phase 2 includes weekly evaluation and iterative re-design of services.

Phase 3: Final Evaluation Phase 3 includes evaluation for potential integration into current policies and frameworks; determination to pursue pending additional factors; or determination of incompatibility, as well as selected support for transition/handover, if applicable.

Conditions

Pregnancy Related

Study Design

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

Study Groups

Intervention

The primary intervention is a multi-phase, mixed methods, implementation research study that will investigate the feasibility and acceptability of the limited introduction of ultrasound via the Butterfly iQ device into routine ANC service delivery at health center level in Blantyre, Malawi. The study will occur in three phases: 1) Training, 2) Iterative Service Delivery, and 3) Final Evaluation.

Group Type: OTHER

Butterfly iQ

Intervention Type: DEVICE

The primary intervention under study is the Butterfly iQ point-of-care ultrasound device, embedded in a larger program of training, iterative ANC service delivery design, and a final program evaluation.

Interventions

Butterfly iQ

The primary intervention under study is the Butterfly iQ point-of-care ultrasound device, embedded in a larger program of training, iterative ANC service delivery design, and a final program evaluation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Member of HC or hospital staff providing obstetric care.

2. Able and willing to comply with all study requirements and complete all study procedures.

3. Able and willing to provide informed consent to be screened for and to take part in the study.

Study Participant - Health Center and Hospital Staff:

1. Member of HC or hospital staff providing obstetric care.

2. Able and willing to comply with all study requirements and complete all study procedures.

3. Able and willing to provide informed consent to be screened for and to take part in the study.

Study Participant - ANC Clients:

Participants must meet all criteria to be eligible for inclusion in the study:

1. Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs).

2. At enrollment, present for first ANC visit.

3. Able and willing to comply with all study requirements and complete all Phase 2 study procedures.

4. Able and willing to provide informed consent to be screened for and to take part in Phase 2 of the study.

5. Intention to stay within study catchment area for study Phase 2 duration and willingness to give adequate locator information, as defined in site SOPs.

1. Participated in Phase 1 or 2 of the study or newly recruited stakeholder interested in development or implementation of obstetric ultrasound in Malawi.

2. Able and willing to comply with all study requirements and complete all Phase 3 study procedures.

3. Able and willing to provide informed consent to be screened for and to take part in Phase 3 of the study.

Exclusion Criteria

Study Participant - Health Center and Hospital Staff:

1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Study participant - ANC Clients:

1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

Kamuzu University of Health Sciences

OTHER

Sponsor Role: collaborator

Ministry of Health, Malawi

OTHER_GOV

Sponsor Role: collaborator

Jhpiego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa M Noguchi, PhD, MSN

Role: STUDY_DIRECTOR

Jhpiego, Johns Hopkins University

Linly Seyama

Role: PRINCIPAL_INVESTIGATOR

University of Malawi College of Medicine, JHP Blantyre

Locations

Johns Hopkins Research Project

Blantyre, , Malawi

Countries

Malawi

Other Identifiers

ARC-005

Identifier Type: -

Identifier Source: org_study_id