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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Self-Sampling for HPV Testing in African American Women - Mississippi Delta

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Pap testing
* Behavioral: Choice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no personal history of cervical cancer not have engaged in cervical cancer screening in the past four years Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pap testing<br>Women assigned to this arm will be scheduled a Pap testing appointment at the local health department | Behavioral: Pap testing<br>* 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<br>|
| Experimental: Choice<br>Women assigned to this arm will be given a choice between scheduling an appointment for a Pap testing at the health department or engage in self-sampling for HPV testing at home | Behavioral: Choice<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to cervical cancer screening | adherence to cerivcal cancer screening by attending the Pap testing or returning the self-collected sample for HPV testing | baseline to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the intervention | We will assess participants' satisfaction with intervention through self-report (satisfaction questionnaire - satisfied/very satisfied) | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-sampling for HPV testing