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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

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.

Condition or disease Intervention/treatment Phase
Contraception Behavior Behavioral: Intervention video Behavioral: Control video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : September 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Intervention video
The intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety.
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.

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.
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03775642


Locations
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Jamaica
Epidemiology Training Unit
Kingston, Jamaica
Sponsors and Collaborators
Ohio State University
FHI 360
Epidemiology Research and Training Unit of the Jamaica Ministry of Health
The University of The West Indies
Investigators
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Principal Investigator: Maria F Gallo, PhD Ohio State University
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Responsible Party: Maria F. Gallo, PhD, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03775642    
Other Study ID Numbers: 2017B0412
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No