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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03081507
Other study ID # 16-00803
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date September 28, 2018

Study information

Verified date December 2018
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Studies have reported Muslims in the US and NYC face numerous language and healthcare access barriers. This is a randomized randomized controlled design will be used to test the efficacy of a Patient Navigation (PN) intervention to increase participation in breast and/or cervical cancer screening among Muslim women age 40 - 75 years living in NYC. Study participants will be randomized to an Lay Health Workers (LHW) led small media intervention arm (SM-LHW) or a LHW-led patient navigation plus small media intervention arm (PN-LHW). A specific aim of the study is to develop, implement and evaluate the efficacy of a two-arm, randomized control trial designed to increase receipt of breast and/or cervical cancer screening among Muslim women aged 40 -75 years in New York City (NYC).


Description:

The goal of this study, entitled Muslim Americans Reaching for Health and Building Alliances (MARHABA), is to evaluate the effectiveness of a culturally patient navigation (PN) intervention designed for Muslim women to increase breast and cervical cancer screening participation.


Recruitment information / eligibility

Status Completed
Enrollment 432
Est. completion date September 28, 2018
Est. primary completion date September 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria:

- self-identify as Muslim

- female

- residence in a NYC borough

- self-report as having received a mammogram more than two years ago and are age 40-74 years

- self-report having received a Pap test more than three years ago and are age 40-65 years

Exclusion Criteria:

- Report a past or current diagnosis of breast or cervical cancer

- Report having had a hysterectomy

- Report having had breast reconstructive surgery

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SM-LHW
Will not receive additional follow-up from the LHW, but will be encouraged during the session to make an appointment with their provider to schedule a mammogram and Pap test, or to consult the MARHABA webpage for information on low-cost and culturally appropriate referral sources of screening. Individuals assigned to this arm who did not attend an educational seminar will be mailed a packet containing a palm card, brochure, and letter encouraging them to speak with their provider about breast and cervical cancer screening and/or going to the MARHABA webpage. LHWs will complete a follow-up survey with participants by phone or in-person at 4 months after baseline
PN-LHW
PNLHW participants will receive three planned contacts with LHWs that focus on navigation for obtaining mammogram and/or Pap testing.The initial contact will be made by phone and will focus on motivating participants to make an appointment with their primary care provider and/or obstetrician/gynecologist (OB/GYN), as well as provide information on low-cost or free care if necessary. The second contact will discuss the process of going to the appointment and the third contact will focus on the process of obtaining and interpreting. The second and third contacts will be either made by phone or in-person, depending on participant needs.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Awareness of Pap Test Pap test awareness is a positive response to the following question: "Have you ever heard of a 'Pap test'?" 5 Months
Primary Awareness of Mammogram Awareness is a positive response to the following question: "Have you ever heard of a 'mammogram'?" 5 Months
Primary Pap test receipt Pap test receipt is defined as a positive response to "Have you ever had a 'Pap test'?" after describing the test. For "no" responses, we defined Pap test intention as a positive response to "Are you planning on obtaining a 'Pap test'?" 5 Months
Primary Mammogram test receipt Mammogram test receipt is defined as a positive response to "Have you ever had a 'Mammogram'?" after describing the test. For "no" responses, we defined Mammogram test intention as a positive response to "Are you planning on obtaining a 'Mammogram'?" 5 Months
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