Assessment of Cultural Acceptability of Long Acting Contraception in a Diverse, Urban Population

May 7, 2020 updated by: Jeannette E. South-Paul, University of Pittsburgh
Preliminary data from our work with teen mothers suggest that many women would benefit from contraception but do not actually make visits nor initiate conversations regarding contraception unless the subject is raised by the clinician. Those coming for primary care visits discuss their conditions and care with family and friends, spreading health care information. A substantial proportion of citizens obtain their health information from friends, family, internet, social media and other non-clinicians. Thus, educating women, even when not coming expressly for contraceptive services, increases more accurate health information throughout their communities and actually identifies fertility needs, ultimately increasing use of contraception.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Seven clinical family medicine health centers will be included in the study. Target participants are women aged 18-45 years old. These clinical sites are community-based health centers within the University of Pittsburgh Medical Center (UPMC) system in greater Pittsburgh that serve as teaching sites for medical, pharmacy and social work students enrolled at the University of Pittsburgh and/or UPMC Family Medicine or clinical pharmacy residents. In 2015, these sites served nearly 32,000 patients of whom more than 60% are women. More than 10,000 females were in the target age group of 18-45 years old and more than half were from underrepresented minority groups. The patients served by these family health centers are diverse across race and ethnicity, family income level, neighborhoods and literacy level . All are managed and documented in the EpicCare electronic medical record system.

We target women aged 18-45 years because this study is designed to assess cultural beliefs regarding Long Acting Reversible Contraception (LARC) in women in general and not specifically those who are seeking contraception. Preliminary data from our work with teen mothers suggest that many women would benefit from contraception but do not actually make visits nor initiate conversations regarding contraception unless the subject is raised by the clinician. Those coming for primary care visits discuss their conditions and care with family and friends, spreading health care information. A substantial proportion of citizens obtain their health information from friends, family, and other non-clinicians. Thus, educating women, even when not coming expressly for contraceptive services, increases more accurate health information throughout their communities and actually identifies fertility needs, ultimately increasing use of contraception.

Seven clinical sites (UPMC Family Health Centers) will be included in the study. The best and low-cost recruitment strategy will be to reach women aged 18-45 years who attend our health centers for womens' health services. Our project team will engage personnel in these health centers and inform them about the proposed study. We will place postcards at the check-in desk, and encourage target women to take a postcards and follow up with the research team if they are interested in participating.

Participants of the project will be identified by the nurses performing initial intakes of patients presenting for care - also called "rooming" the patient. Research assistants will also try to approach patients in the waiting room in the case they were not able to approach them in the examination rooms. Those recruited from each site will be stratified to one of two groups - one for those identifying contraception as the focus of their physician visit and the other group for those seeking other women's health services at the physician visit.

In an effort to improve recruitment, we will work with the clinical staff to understand particular hours during which potential participants are likely to present to the clinic. Flyers will be placed in all seven health centers, In addition, a research assistant will be on site at projected high utilization times. The research assistants will provide information on the study to clinical staff, and will be available to distribute study postcards and answer questions from potential participants. Interested young women will meet with the research assistants for eligibility determination, completion of Institutional Review Board (IRB) consents, and enrollment in the study. Incentives will be provided to all participants enrolled in the study.

Three health centers received a substantial volume of the female patients who were in the specific age group being targeted in the study will be invited to comprise the intervention arm. The rest of the health centers will form the control arm.

It is important that the survey questions reflect the target population's perspectives of using LARC or any contraceptive devices. Both the demographic and cultural surveys will be distributed to women, 18-45 years of age, seeking womens' health services in participating family health centers who expressed interest in the study. Surveys will be completed on a tablet provided by a research assistant or on the participant's own mobile device or personal computer. Participants will be given the option to complete the surveys at the family health center or elsewhere at another time. Women participating in the focus groups are ineligible for participation in the survey.

Participants in the intervention arm will complete both the demographic and the cultural survey. After participating in the survey, the participants in the intervention arm will be asked to watch an educational video on LARC to be taped by a professional team in the Center for Instructional Development & Distance Education (CIDDE) at the University of Pittsburgh. In this video, a family physician skilled in contraceptive education will provide useful and easily understandable information on LARC. The video will include, but is not limited to, the following key topics:

  • What types of LARC are available?
  • How each LARC method works?
  • How and where the LARC method is inserted?
  • How long LARC works?
  • What are the risks and benefits of each LARC method?
  • Can LARC be removed at any time, how it is removed and are there any potential side effects such as slow return of fertility?

A short survey will be distributed to all participants who watched the video in the intervention arm. The survey will include questions on LARC that were similar to the questions included in the survey before watching the video. We will then evaluate both surveys before and after watching the video. The participants will be given the option to complete all study activities at the family health center or elsewhere at another time.

With improved understanding regarding how LARC is perceived through data obtained from the cultural assessment, more targeted education for both clinicians, clinical staff, and patients of childbearing age is possible. Therefore, if the cultural assessment (via focus group feedback and/or survey responses) reveals that patients fear permanent sterilization or believe use of LARC violates religious mores, patient education can be modified to address their specific concerns. These study results may lead to further investigation to change approaches to the target population and allow us to provide better clinical care

Following (1) assessment of historical data on LARC use in the seven health centers prior to this study; (2) perceptions elicited from the focus groups(from phase one of the study); (3) results of the group completing both demographic and cultural surveys; and (4) results of the group completing demographic and cultural surveys and watching the informational video, the final step involves assessing changes in LARC use. Electronic medical records and billing data from the seven health centers will be reviewed to determine LARC utilization across the targeted population served by these health centers and the impact of the interventions on LARC usage.

Study Type

Interventional

Enrollment (Actual)

437

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
    • Pennsylvania
      • McKeesport, Pennsylvania, United States, 15132
        • Latterman Family Health Center
      • New Kensington, Pennsylvania, United States, 15068
        • New Kensington Family Health Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Matilda Theiss Health Center
      • Pittsburgh, Pennsylvania, United States, 15217
        • Squirrel Hill Family Practice
      • Pittsburgh, Pennsylvania, United States, 15224
        • UPMC Bloomfiled-Garfield FHC
      • Pittsburgh, Pennsylvania, United States, 15232
        • Lawrenceville Family Health Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Shadyside Family Health Center

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Between age of 18 and 45
  • Not currently pregnant
  • Did not participate in phase I of the study

Exclusion Criteria:

  • Below 18 years or above 45
  • Currently pregnant
  • Participated in Phase I of the study

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Participants in the intervention arm will be asked to watch a short educational video on LARC (Long acting reversible contraceptive) and to complete a survey before and after watching the video.
Behavioral: Educational video on LARC
Participants will watch a short educational video on long acting reversible contraceptive or LARC
No Intervention: Control arm
Participants in the intervention arm will only be asked to complete a survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine cultural factors that affect women choosing their contraception.
Time Frame: 2 years
Racial and ethnic minority women are less likely to use LARC than majority women. No studies have primarily focused on contraceptive cultural beliefs of older teens and young women. Potential factors influencing the low LARC usage among teens are inadequate education regarding safety of these methods, misconceptions among clinicians regarding safety of LARC in teens, fewer than ideal numbers of clinicians trained to insert these devices, barriers to obtaining reimbursement for LARC in hospital settings postpartum
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in LARC uptake among women seeking contraception.
Time Frame: 2 years
A variety of myths regarding LARC have been described. Patient myths and misconceptions include that Intra Uterine Devices (IUDs) cause abortions, pelvic inflammatory disease, ectopic pregnancies, weight gain, hair loss, and cancer, among others. Multiple factors affect women in choosing contraception. Each of these potential factors exists in parallel to and may be influenced by the patient's culture (as defined by age, race, ethnicity, religion, family, nationality, language, education, socioeconomic status, and disability.
2 years
Studying the effects of using contraception educational video on rates of different contraception methods.
Time Frame: 2 years
Educating patients about contraception in general, and LARC in specific,is very crucial. In this study we will ask participants to watch a short educational video on LARC and complete a survey before and after the video. This will enable us to understand how educating patients and providing them with information about contraception might affect their perspectives on LARC.
2 years

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Jeannette E. South-Paul, MD, University of Pittsburgh

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)

April 15, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

April 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Merck IIS# 55000 phase II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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