Clinical trial NCT05054504: Feasibility and Acceptability of Butterfly iQ
Official title: Integration of Butterfly iQ Point of Care Ultrasound Into Antenatal Care in Blantyre, Malawi: A Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Butterfly IQ
Malawi
Blantyre
Antenatal care
ANC/PNC Research Collective
Point of care ultrasound
Bill & Melinda Gates Foundation
Johns Hopkins Research Project
Johns Hopkins Bloomberg School of Public Health
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Johns Hopkins Bloomberg School of Public Health
name: Kamuzu University of Health Sciences
name: Ministry of Health, Malawi
First posted: 2021-09-23
Enrollment: 1575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The primary intervention under study is the Butterfly iQ ultrasound, embedded in a larger program of training, iterative service delivery design, and a final program evaluation.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Eligibility criteria by phase and participant type

Phase 1 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.

Phase 1 Exclusion Criteria 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.

Phase 2 Inclusion Criteria

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.

Phase 2 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

Phase 3 Inclusion Criteria

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.

Phase 3 Exclusion Criteria

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

Primary outcomes:
measure: Feasibility of the intervention by participant report
timeFrame: 7 months
measure: Feasibility of the intervention by quality standards met (ultrasound)
timeFrame: 7 months
measure: Feasibility of the intervention by quality standards met (ANC)
timeFrame: 7 months
measure: Feasibility of the intervention by observation of functioning systems
timeFrame: 7 months
measure: Feasibility of the intervention by observation of environments of care
timeFrame: 7 months
Secondary outcomes:
measure: Acceptability, by participant report (providers)
timeFrame: 7 months
measure: Acceptability, by participant report (ANC clients)
timeFrame: 7 months
Other outcomes:
measure: Gestational age at first ANC contact
timeFrame: 7 months
measure: Number and types of suspected and confirmed higher-risk conditions identified by ultrasound and recorded in study records
timeFrame: 7 months
Locations:
city: Blantyre
country: Malawi
facility: Johns Hopkins Research Project
Study officials:
affiliation: Jhpiego, Johns Hopkins University
name: Lisa M Noguchi, PhD, MSN
role: STUDY_DIRECTOR
affiliation: University of Malawi College of Medicine, JHP Blantyre
name: Linly Seyama
role: PRINCIPAL_INVESTIGATOR
References: