Self-Sampling for Human Papillomavirus (HPV) Testing in African American Women - Mississippi Delta
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 25 - 64 |
| Updated: | 10/25/2018 |
| Start Date: | November 28, 2016 |
| End Date: | November 30, 2020 |
| Contact: | Isabel C Scarinci, PhD |
| Email: | scarinci@uab.edu |
| Phone: | 205-975-7177 |
Self-Sampling for HPV Testing in African American Women - Mississippi Delta
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).
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).
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.
("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.
Inclusion Criteria:
- no personal history of cervical cancer
- not have engaged in cervical cancer screening in the past four years
Exclusion Criteria:
We found this trial at
1
site
Jackson, Mississippi 39215
Principal Investigator: Isabel C Scarinci, PhD
Phone: 662-453-4563
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