Clinical trial NCT03713710: Self-Sampling for Human Papillomavirus (HPV) Testing in African American Women - Mississippi Delta
Official title: Self-Sampling for HPV Testing in African American Women - Mississippi Delta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: self-sampling for HPV testing
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2018-10-22
Enrollment: 335
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to examine the efficacy and costs of this patient-centered approach ("Choice" between two cervical cancer screening modalities) in adherence to cervical cancer screening as compared to the current standard of care within the public health system in Mississippi (Pap test at the local department -"Pap") among un/under-screened African American women in the Mississippi Delta using a theory-based, culturally relevant intervention implemented by Peer Health Educators (PHEs).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: adherence to cervical cancer screening
timeFrame: baseline to 30 days
Secondary outcomes:
measure: Satisfaction with the intervention
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Mississippi State Department of Health
state: Mississippi
Study officials:
affiliation: University of Alabama at Birmingham
name: Isabel C. Scarinci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.