NCT03775642

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

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2019

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

December 11, 2018

Last Update Submit

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

EXPERIMENTAL

The intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety.

Behavioral: Intervention video

Control video

PLACEBO COMPARATOR

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

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.

Intervention video
Control videoBEHAVIORAL

The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration

Control video

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Epidemiology Training Unit

Kingston, Jamaica

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Maria F Gallo, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

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

Locations