Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
1 other identifier
interventional
225
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2018
CompletedFirst Submitted
Initial submission to the registry
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2019
CompletedApril 16, 2020
April 1, 2020
10 months
December 11, 2018
April 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)
Based on survey question on use of the IUD (y/n) and implant (y/n)
within 3 months of enrollment
Secondary Outcomes (3)
Self-reported belief about IUD safety
3 months after enrollment
Self-reported belief about implant safety
3 months after enrollment
Self-reported attitudes toward LARC-related bleeding patterns
3 months after enrollment
Study Arms (2)
Intervention video
EXPERIMENTALThe intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety.
Control video
PLACEBO COMPARATORThe video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration.
Interventions
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.
The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration
Eligibility Criteria
You may qualify if:
- present at the Comprehensive Health Centre;
- years of age; and
- sexually active (defined as ≥1 penile-vaginal act in past month);
You may not qualify if:
- known to be pregnant;
- sterilized;
- breastfeeding;
- currently using the IUD or implant; or
- want pregnancy in the next 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- FHI 360collaborator
- Epidemiology Research and Training Unit of the Jamaica Ministry of Healthcollaborator
- The University of The West Indiescollaborator
Study Sites (1)
Epidemiology Training Unit
Kingston, Jamaica
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria F Gallo, PhD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 14, 2018
Study Start
November 21, 2018
Primary Completion
September 5, 2019
Study Completion
September 5, 2019
Last Updated
April 16, 2020
Record last verified: 2020-04