Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

NCT ID: NCT03775642

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-21

Study Completion Date

2019-09-05

Brief Summary

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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

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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.

Conditions

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Contraception Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention video

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

Group Type EXPERIMENTAL

Intervention video

Intervention Type BEHAVIORAL

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.

Control video

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

Group Type PLACEBO_COMPARATOR

Control video

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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FHI 360

OTHER

Sponsor Role collaborator

Epidemiology Research and Training Unit of the Jamaica Ministry of Health

UNKNOWN

Sponsor Role collaborator

The University of The West Indies

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Maria F. Gallo, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria F Gallo, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Epidemiology Training Unit

Kingston, , Jamaica

Site Status

Countries

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Jamaica

Other Identifiers

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2017B0412

Identifier Type: -

Identifier Source: org_study_id

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