Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

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.

Study Overview

• Status: Completed
• Conditions: Contraception Behavior
• Intervention / Treatment: Behavioral: Intervention video; Behavioral: Control video

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: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jamaica
  • Kingston, Jamaica
    • Epidemiology Training Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported belief about IUD safety	"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.	3 months after enrollment
Self-reported belief about implant safety	"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 months after enrollment
Self-reported attitudes toward LARC-related bleeding patterns	"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	3 months after enrollment

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: FHI 360; The University of The West Indies; Epidemiology Research and Training Unit of the Jamaica Ministry of Health
• Investigators: Principal Investigator: Maria F Gallo, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): September 5, 2019
• Study Completion (Actual): September 5, 2019

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017B0412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No