Self-Sampling for Human Papillomavirus (HPV) Testing in African American Women - Mississippi Delta

OBJECTIVE: Our objective is to examine the efficacy and costs of a patient-centered approach ("Choice" between self-sampling and Pap test) in adherence to cervical cancer screening as compared to Pap test at the local health department ("Pap") among un/under-screened African American women in the Mississippi Delta.

HYPOTHESES: Women in the "Choice" arm will have a higher cervical cancer screening adherence as well as higher satisfaction than women assigned to the "Pap" arm; (2) Within the "Choice" arm, more women will choose and complete self-sampling than Pap test; and (3) The "Choice" intervention will be on average less costly and more cost-effective than the "Pap" intervention.

SPECIFIC AIMS: (1) To compare the impact of these two intervention approaches, "Choice" versus "Pap", on cervical cancer screening adherence through a group randomized controlled trial; (2) To compare patient satisfaction between the two intervention approaches; and (3) To compare the costs and cost-effectiveness of these two intervention approaches, "Choice" versus "Pap".

STUDY DESIGN: 12 towns will be randomized to either "Choice" or "Pap" (180 women/arm). Peer Health Educators (PHEs) will identify African American women who report not having undergone cervical cancer screening in the past three years and deliver a brief theory-based, cultural relevant educational session on cervical cancer and screening using a door-to-door approach. Women randomized to the "Pap" arm will be provided with information on how to schedule an appointment at the local health department. Women randomized to the "Choice" arm will be given the choice of attending the health department for a Pap test or self-collecting their own sample at home to be sent for HPV testing. PHEs will follow-up with women in either arm who have a positive test in order to assure diagnostic evaluation and care.

• Pap testing (Behavioral): Women will be approached in the community by a Peer Health Educator and scheduled an appointment for a Pap testing at the local health department
• Choice (Behavioral): Women will be approached in the community by a Peer Health Educator and they will be given a choice between scheduling an appointment for a Pap testing at the local health department or engage in self-sampling for HPV testing at home

Primary outcomes

• adherence to cervical cancer screening [baseline to 30 days]: adherence to cerivcal cancer screening by attending the Pap testing or returning the self-collected sample for HPV testing

Secondary outcomes

• Satisfaction with the intervention [baseline to 6 months]: We will assess participants' satisfaction with intervention through self-report (satisfaction questionnaire - satisfied/very satisfied)

Sex: Female, ages: 25 Years to 64 Years, accepts healthy volunteers

Inclusion Criteria:

* no personal history of cervical cancer
* not have engaged in cervical cancer screening in the past four years

Exclusion Criteria:

* none

• Results publication: Scarinci IC, Li Y, Tucker L, Campos NG, Kim JJ, Peral S, Castle PE. Given a choice between self-sampling at home for HPV testing and standard of care screening at the clinic, what do African American women choose? Findings from a group randomized controlled trial. Prev Med. 2021 Jan;142:106358. doi: 10.1016/j.ypmed.2020.106358. Epub 2020 Dec 16. PMID 33338505

• Isabel C. Scarinci, PhD, Principal investigator, University of Alabama at Birmingham