Document is current

Article History

Received: 17 September 2020

Accepted: 5 October 2020

First Online: 21 October 2020

Ethics approval and consent to participate

: The trial was approved by the Institutional Review Board (IRB) for Baylor College of Medicine (H-44944) and granted administrative approval by Harris Health System (19-04-2148). A waiver of informed consent was granted by the IRB to identify eligible women using the EMR and to randomize them to study arms. All eligible participants are enrolled under a waiver of informed consent to minimize participation bias. A waiver of written documentation of informed consent was granted for participants’ use of the self-sampling kits, given the minimal risks involved and to enhance generalizability of the findings. Verbal informed consent will be obtained from all women who participate in the telephone survey and in-depth interviews. Protocol amendments are submitted for review and approval by the IRB. If relevant, approved modifications are updated in the trial registry.

: All authors consent to publication of this research. Trial participants are enrolled under a waiver of consent and thus have not provided consent for publication of this protocol.

: The authors declare that they have not competing interests.