Community Awareness Resources and Education - Project 1

Study Overview
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Brief Summary
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To increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary.

Detailed Description
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The overall goal of Project 1 is to increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary. The project was implemented in Appalachian Ohio, a mainly rural and underserved area with a population comprised of 1.5 million adults, aged 18 and older, and used community-based participatory research (CBPR) and community relationships already established in the area by Center investigators.

Official Title
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Reducing Cervical Cancer in Appalachia

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Lay Health Advisor Education Intervention
* Behavioral: Usual Care Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women age 18 and older who have visited participating clinics during the last two years and who consider themselves to be a current patient of that clinic Exclusion Criteria: Not a resident of the selected Ohio Appalachia county Under the age of 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group<br>All women over age 18 encouraged to obtain Pap smears appropriate for their risk profile, the comparison arm included a low-literacy brochure to encourage women to receive screening. The brochure was designed to answer basic questions about Pap smears and provide instructions on how to obtain a Pap smear. | Behavioral: Usual Care Group<br>* All women over age 18 encouraged to obtain Pap smears appropriate for their risk profile, the comparison arm included a low-literacy brochure to encourage women to receive screening. The brochure was designed to answer basic questions about Pap smears and provide instructions on how to obtain a Pap smear.<br>|
| Experimental: Lay Health Advisor Intervention<br>The Lay Health Advisor education intervention - The intervention consisted of an intensive, reinforced, one on one, interactive ed. program (an initial meeting, then 2 calls and a series of 4 postcards mailed at regular intervals and a 2nd visit. Woman were enrolled for about 12 to 14 months. | Behavioral: Lay Health Advisor Education Intervention<br>* The individualized health education intervention consisted of an intensive, reinforced, face to face, interactive educational program. The program included an initial meeting of 45 60 minutes, followed by two telephone calls and reinforcement by a series of four postcards mailed at regular intervals and a second visit. Each woman will be enrolled in the intervention program for approximately 12 to 14 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of Cervical Cancer screening via Pap Test | the primary outcome of interest for Project 1 intervention will be a dichotomous variable, Pap smear in the past 12-14 months (yes/no). Initially, We will assess the univariate difference between treatment groups (lay health advisor vs. brochure and physician letter) in the proportion of women who received a Pap smear during the past 12 months using design-based logistic regression. | past 12-14 months (yes/no). |