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Article History

Received: 24 June 2020

Accepted: 16 December 2020

First Online: 6 January 2021

Ethics approval and consent to participate

: This study obtained Institutional Review Board approval from The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (Study Number 19–2756) before participant recruitment and enrollment. Any protocol amendments will be agreed upon by the steering committee, principal investigator, and staff members and approved by the Institutional Review Board prior to implementation. Written and verbal consent will be obtained from all women interested in joining the study. Women who are interested in participating will meet with a research assistant in person, or on the phone, who will explain the risks and benefits and complete a screening questionnaire. If they appear to meet inclusion criteria, study staff will meet the women at the community site or participant home to confirm eligibility and obtain consent. Participants will be informed that joining the study is voluntary, and they can stop at any time. Refusing to join the study or stopping the study will not affect their care. Participants will be given a copy of the consent with contact information for the study office. Participants are encouraged to contact study staff at any time if she has concerns or questions.

: Not applicable.

: The authors declare that they have no competing interests.