NCT03979950

Brief Summary

The purpose of this study is to use an electronic survey to explore Solid Organ Transplant patients' contraceptive knowledge and counseling. The results from this survey will be used to help identify awareness gaps to potentially develop targeted interventions for comprehensive education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 18, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

March 13, 2018

Last Update Submit

March 28, 2023

Conditions

Keywords

organ transplant

Outcome Measures

Primary Outcomes (3)

  • Level of knowledge among solid organ transplant patients about contraceptive methods

    The survey questionnaire asks multiple-choice questions about (1) available contraceptive methods, (2) the safety profile of methods for women with transplant histories, and (3) the teratogenic risks of post-transplant medications.

    Three years

  • Quantity of contraceptive counseling for solid organ transplant patients

    The survey questionnaire asks multiple-choice questions about (1) whether patients received counseling about contraception and (2) if they want more counseling on contraception.

    Three years

  • Number of participants counseled on contraception by provider

    The survey questionnaire asked multiple-choice questions about (1) which, if any, provider(s) counseled them on contraception and (2) from which provider(s), if any, would they prefer to receive contraceptive counseling.

    Three years

Interventions

SurveyBEHAVIORAL

Solid Organ Transplant patients will be recruited via social media. Co-investigators will reach out to the administrators of various social media networks to share information regarding the study with their networks on our behalf. Potential participants who are interested in participating, can then follow the link to the online survey tool, which includes the participant demographic information (age, ethnicity and highest level of education) and questionnaire. The questionnaire is 30 questions long and takes approximately 15 minutes to complete. This questionnaire will be a single, cross-sectional survey. No personal information will be documented on the questionnaire. All responses will be anonymous. Participants will be recruited for 6 months.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women 18-50 years, solid organ transplant in the last 5 years, and fluent in English.

You may qualify if:

  • Women 18-50 years old, solid organ transplant in the last 5 years, and fluent in English.

You may not qualify if:

  • Not sexually active with men, history of hysterectomy, history of oophorectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (6)

  • Organ Procurement and Transplantation Network. Organ Procurement and Transplantation Network, HRSA, DHHS 9 A.D. November 10. Available from http://optn.transplant.hrsa.gov/.

    BACKGROUND
  • Lessan-Pezeshki M, Ghazizadeh S, Khatami MR, Mahdavi M, Razeghi E, Seifi S, Ahmadi F, Maziar S. Fertility and contraceptive issues after kidney transplantation in women. Transplant Proc. 2004 Jun;36(5):1405-6. doi: 10.1016/j.transproceed.2004.04.090.

    PMID: 15251344BACKGROUND
  • McKay DB, Josephson MA, Armenti VT, August P, Coscia LA, Davis CL, Davison JM, Easterling T, Friedman JE, Hou S, Karlix J, Lake KD, Lindheimer M, Matas AJ, Moritz MJ, Riely CA, Ross LF, Scott JR, Wagoner LE, Wrenshall L, Adams PL, Bumgardner GL, Fine RN, Goral S, Krams SM, Martinez OM, Tolkoff-Rubin N, Pavlakis M, Scantlebury V; Women's Health Committee of the American Society of Transplantation. Reproduction and transplantation: report on the AST Consensus Conference on Reproductive Issues and Transplantation. Am J Transplant. 2005 Jul;5(7):1592-9. doi: 10.1111/j.1600-6143.2005.00969.x.

    PMID: 15943616BACKGROUND
  • McKay DB, Adams PL, Bumgardner GL, Davis CL, Fine RN, Krams SM, Martinez OM, Murphy B, Pavlakis M, Tolkoff-Rubin N, Sherman MS, Josephson MA. Reproduction and pregnancy in transplant recipients: current practices. Prog Transplant. 2006 Jun;16(2):127-32. doi: 10.1177/152692480601600206.

    PMID: 16789701BACKGROUND
  • Centers for Disease Control and Prevention (CDC). U S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Recomm Rep. 2010 Jun 18;59(RR-4):1-86.

    PMID: 20559203BACKGROUND
  • Guazzelli CA, Torloni MR, Sanches TF, Barbieri M, Pestana JO. Contraceptive counseling and use among 197 female kidney transplant recipients. Transplantation. 2008 Sep 15;86(5):669-72. doi: 10.1097/TP.0b013e3181817e7d.

    PMID: 18791448BACKGROUND

Related Links

MeSH Terms

Conditions

Contraception Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sheila Mody, MD, MPH

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2018

First Posted

June 10, 2019

Study Start

January 18, 2018

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations