Muslim Americans Reaching for Health and Building Alliances (MARHABA): Patient Navigation Intervention to Increase Breast and Cervical Cancer Screening Among Muslim Women in New York City (MARHABA)

December 4, 2018 updated by: NYU Langone Health
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

432

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10017
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LHW-led small media intervention arm (SM-LHW)
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
Experimental: LHW-led plus small media intervention arm (PN-LHW)
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Awareness of Pap Test
Time Frame: 5 Months
Pap test awareness is a positive response to the following question: "Have you ever heard of a 'Pap test'?"
5 Months
Awareness of Mammogram
Time Frame: 5 Months
Awareness is a positive response to the following question: "Have you ever heard of a 'mammogram'?"
5 Months
Pap test receipt
Time Frame: 5 Months
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
Mammogram test receipt
Time Frame: 5 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

September 20, 2018

Study Completion (Actual)

September 28, 2018

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (Actual)

March 16, 2017

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-00803

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on SM-LHW

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe