NCT03486743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
437

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

March 27, 2018

Last Update Submit

May 7, 2020

Conditions

Keywords

LARC contraception cultural acceptance

Outcome Measures

Primary Outcomes (1)

  • Determine cultural factors that affect women choosing their contraception.

    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 Outcomes (2)

  • Changes in LARC uptake among women seeking contraception.

    2 years

  • Studying the effects of using contraception educational video on rates of different contraception methods.

    2 years

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Participants in the intervention arm will only be asked to complete a survey.

Interventions

Participants will watch a short educational video on long acting reversible contraceptive or LARC

Intervention arm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWe 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.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Latterman Family Health Center

McKeesport, Pennsylvania, 15132, United States

Location

New Kensington Family Health Center

New Kensington, Pennsylvania, 15068, United States

Location

UPMC Matilda Theiss Health Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Squirrel Hill Family Practice

Pittsburgh, Pennsylvania, 15217, United States

Location

UPMC Bloomfiled-Garfield FHC

Pittsburgh, Pennsylvania, 15224, United States

Location

Lawrenceville Family Health Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Shadyside Family Health Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (17)

  • Mestad R, Secura G, Allsworth JE, Madden T, Zhao Q, Peipert JF. Acceptance of long-acting reversible contraceptive methods by adolescent participants in the Contraceptive CHOICE Project. Contraception. 2011 Nov;84(5):493-8. doi: 10.1016/j.contraception.2011.03.001. Epub 2011 Apr 27.

    PMID: 22018123BACKGROUND
  • Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.

    PMID: 20541171BACKGROUND
  • Romero L, Pazol K, Warner L, Gavin L, Moskosky S, Besera G, Loyola Briceno AC, Jatlaoui T, Barfield W; Centers for Disease Control and Prevention (CDC). Vital signs: trends in use of long-acting reversible contraception among teens aged 15-19 years seeking contraceptive services-United States, 2005-2013. MMWR Morb Mortal Wkly Rep. 2015 Apr 10;64(13):363-9.

    PMID: 25856258BACKGROUND
  • Harper CC, Blum M, de Bocanegra HT, Darney PD, Speidel JJ, Policar M, Drey EA. Challenges in translating evidence to practice: the provision of intrauterine contraception. Obstet Gynecol. 2008 Jun;111(6):1359-69. doi: 10.1097/AOG.0b013e318173fd83.

    PMID: 18515520BACKGROUND
  • Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.

    PMID: 17138775BACKGROUND
  • Whitaker AK, Sisco KM, Tomlinson AN, Dude AM, Martins SL. Use of the intrauterine device among adolescent and young adult women in the United States from 2002 to 2010. J Adolesc Health. 2013 Sep;53(3):401-6. doi: 10.1016/j.jadohealth.2013.04.011. Epub 2013 Jun 12.

    PMID: 23763968BACKGROUND
  • Damle LF, Gohari AC, McEvoy AK, Desale SY, Gomez-Lobo V. Early initiation of postpartum contraception: does it decrease rapid repeat pregnancy in adolescents? J Pediatr Adolesc Gynecol. 2015 Feb;28(1):57-62. doi: 10.1016/j.jpag.2014.04.005. Epub 2014 May 5.

    PMID: 25555302BACKGROUND
  • Okpo E, Allerton L, Brechin S. 'But you can't reverse a hysterectomy!' Perceptions of long acting reversible contraception (LARC) among young women aged 16-24 years: a qualitative study. Public Health. 2014 Oct;128(10):934-9. doi: 10.1016/j.puhe.2014.08.012. Epub 2014 Oct 22.

    PMID: 25369357BACKGROUND
  • Greenberg KB, Makino KK, Coles MS. Factors associated with provision of long-acting reversible contraception among adolescent health care providers. J Adolesc Health. 2013 Mar;52(3):372-4. doi: 10.1016/j.jadohealth.2012.11.003.

    PMID: 23427785BACKGROUND
  • Rubin SE, Davis K, McKee MD. New york city physicians' views of providing long-acting reversible contraception to adolescents. Ann Fam Med. 2013 Mar-Apr;11(2):130-6. doi: 10.1370/afm.1450.

    PMID: 23508599BACKGROUND
  • Russo JA, Miller E, Gold MA. Myths and misconceptions about long-acting reversible contraception (LARC). J Adolesc Health. 2013 Apr;52(4 Suppl):S14-21. doi: 10.1016/j.jadohealth.2013.02.003.

    PMID: 23535052BACKGROUND
  • Roncancio AM, Ward KK, Berenson AB. The use of effective contraception among young Hispanic women: the role of acculturation. J Pediatr Adolesc Gynecol. 2012 Feb;25(1):35-8. doi: 10.1016/j.jpag.2011.08.008. Epub 2011 Nov 3.

    PMID: 22051784BACKGROUND
  • Doescher MP, Saver BG, Franks P, Fiscella K. Racial and ethnic disparities in perceptions of physician style and trust. Arch Fam Med. 2000 Nov-Dec;9(10):1156-63. doi: 10.1001/archfami.9.10.1156.

    PMID: 11115223BACKGROUND
  • Kissling E, Valenciano M, Larrauri A, Oroszi B, Cohen JM, Nunes B, Pitigoi D, Rizzo C, Rebolledo J, Paradowska-Stankiewicz I, Jimenez-Jorge S, Horvath JK, Daviaud I, Guiomar R, Necula G, Bella A, O'Donnell J, Gluchowska M, Ciancio BC, Nicoll A, Moren A. Low and decreasing vaccine effectiveness against influenza A(H3) in 2011/12 among vaccination target groups in Europe: results from the I-MOVE multicentre case-control study. Euro Surveill. 2013 Jan 31;18(5):20390. doi: 10.2807/ese.18.05.20390-en.

    PMID: 23399425BACKGROUND
  • deBorja L, Lin C, Maier J, South-Paul JE, Lewis E. Assessment of Cultural Acceptability of Long-Acting Reversible Contraception in a Diverse, Urban Population: Phase II of a Two Phase Study.North American Primary Care Research Group Annual Meeting - NOV 2018 / Chicago, IL (https://www.napcrg.org/conferences/46/sessions/23230)

    RESULT
  • deBorja L. The Role of Social Influence and Usage of Long-Acting Reversible Contraception: Analysis of Survey Responses. North American Primary Care Research Group Annual Meeting - Toronto, ON / NOV. 2019. (https://www.napcrg.org/conferences/2001/sessions/794)

    RESULT
  • Lin CJ, Maier J, Nwankwo C, Burley C, deBorja L, Aaraj YA, Lewis E, Rhem M, Nowalk MP, South-Paul J. Awareness and Use of Contraceptive Methods and Perceptions of Long-Acting Reversible Contraception Among White and Non-White Women. J Womens Health (Larchmt). 2021 Sep;30(9):1313-1320. doi: 10.1089/jwh.2020.8642. Epub 2020 Dec 9.

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Jeannette E. South-Paul, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andrew W. Mathieson UPMC Professor and Chair

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 3, 2018

Study Start

April 15, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations