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Trial record 5 of 7 for:    20541171 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486743
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Jeannette E. South-Paul, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Behavior Behavioral: Educational video on LARC Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: different sites of participant recruitment will be randomized between the use of an informational video during the survey process and no video. The primary focus of the study is the survey that is designed to collect information about cultural perspectives on LARC in the participants.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Cultural Acceptability of Long Acting Contraception in a Diverse, Urban Population
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We target women aged 18-45 years because this study is designed to assess cultural beliefs regarding LARC in women in general and not specifically those who are seeking contraception.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486743


Locations
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United States, Pennsylvania
Latterman Family Health Center
McKeesport, Pennsylvania, United States, 15132
New Kensington Family Health Center
New Kensington, Pennsylvania, United States, 15068
UPMC Matilda Theiss Health Center
Pittsburgh, Pennsylvania, United States, 15213
Squirrel Hill Family Practice
Pittsburgh, Pennsylvania, United States, 15217
UPMC Bloomfiled-Garfield FHC
Pittsburgh, Pennsylvania, United States, 15224
Lawrenceville Family Health Center
Pittsburgh, Pennsylvania, United States, 15232
Shadyside Family Health Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Jeannette E. South-Paul, MD University of Pittsburgh

Publications of Results:
Other Publications:

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Responsible Party: Jeannette E. South-Paul, Andrew W. Mathieson UPMC Professor and Chair, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03486743     History of Changes
Other Study ID Numbers: Merck IIS# 55000 phase II
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeannette E. South-Paul, University of Pittsburgh:
LARC contraception cultural acceptance