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Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

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: NCT03775642
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : April 16, 2020
Sponsor:
Collaborators:
FHI 360
Epidemiology Research and Training Unit of the Jamaica Ministry of Health
The University of The West Indies
Information provided by (Responsible Party):
Maria F. Gallo, PhD, Ohio State University

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE December 14, 2018
Last Update Posted Date April 16, 2020
Actual Study Start Date  ICMJE November 21, 2018
Actual Primary Completion Date September 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use) [ Time Frame: within 3 months of enrollment ]
Based on survey question on use of the IUD (y/n) and implant (y/n)
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
Self-reported initiation of LARC [ Time Frame: within 3 months of enrollment ]
Survey questions on use of the IUD or implant
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Self-reported belief about IUD safety [ Time Frame: 3 months after enrollment ]
    "Do you think the IUD is very safe, mostly safe, mostly unsafe, or very unsafe?" Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.
  • Self-reported belief about implant safety [ Time Frame: 3 months after enrollment ]
    "Do you think the implant is very safe, mostly safe, mostly unsafe, or very unsafe?" Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.
  • Self-reported attitudes toward LARC-related bleeding patterns [ Time Frame: 3 months after enrollment ]
    "How do you feel about your bleeding pattern?" Response options consist of "very satisfied, satisfied, neutral, unsatisfied, very unsatisfied." Responses will be coded as 1-5 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Self-reported concerns about LARC safety [ Time Frame: 3 months after enrollment ]
    Survey questions about beliefs about the safety of LARC
  • Self-reported attitudes toward LARC-related bleeding patterns [ Time Frame: 3 months after enrollment ]
    Survey questions about attitudes about changes in menstrual bleeding patterns
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
Official Title  ICMJE Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
Brief Summary The primary hypothesis is that the intervention video - based on strategies from cognitive psychology - can correct women's misinformation about long-acting reversible contraception (LARC) and result in higher use of LARC. While there are no direct benefits to participants from being in the study, the research could benefit women in general by providing evidence to help prevent unintended pregnancy. Unlike many interventions that are not feasible for scaling up once shown to be effective in changing people's behavior, the proposed intervention has been carefully designed to impose a low burden to clinic staff and require few resources for translating to wider use. Thus, the investigators expect the intervention to have high potential for influencing clinical care and research for addressing the overall goal of reducing unintended pregnancy.
Detailed Description

The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to test the effectiveness of the final intervention video.

Participants in the RT will complete the "Enrollment Questionnaire" and then will be randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm; n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the option of receiving routine contraceptive services that follow standard care. After three months, trained interviewers will contact participants to administer the short "Follow-up Questionnaire" via telephone. To corroborate participant reporting of contraception use during follow-up, the investigators also will extract data on LARC use from participant medical records.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception Behavior
Intervention  ICMJE
  • Behavioral: Intervention video
    The intervention video will employ the debiasing strategies. It will avoid directly articulating contraception-related myths, but instead will provide a limited number of alternative explanations related to IUD and implant safety.
  • Behavioral: Control video
    The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration
Study Arms  ICMJE
  • Experimental: Intervention video
    The intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety.
    Intervention: Behavioral: Intervention video
  • Placebo Comparator: Control video
    The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration.
    Intervention: Behavioral: Control video
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2020)
225
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
220
Actual Study Completion Date  ICMJE September 5, 2019
Actual Primary Completion Date September 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • present at the Comprehensive Health Centre;
  • 18-25 years of age; and
  • sexually active (defined as ≥1 penile-vaginal act in past month);

Exclusion Criteria:

  • known to be pregnant;
  • sterilized;
  • breastfeeding;
  • currently using the IUD or implant; or
  • want pregnancy in the next 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jamaica
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03775642
Other Study ID Numbers  ICMJE 2017B0412
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Maria F. Gallo, PhD, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE
  • FHI 360
  • Epidemiology Research and Training Unit of the Jamaica Ministry of Health
  • The University of The West Indies
Investigators  ICMJE
Principal Investigator: Maria F Gallo, PhD Ohio State University
PRS Account Ohio State University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP