Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

Contraception Behavior Clinical Trial

Official title:

Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775642
• Other study ID #: 2017B0412
• Status: Completed
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: September 5, 2019

Study information

• Verified date: April 2020
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

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

Locations

Country	Name	City	State
Jamaica	Epidemiology Training Unit	Kingston

Sponsors (4)

Lead Sponsor	Collaborator
Ohio State University	Epidemiology Research and Training Unit of the Jamaica Ministry of Health, FHI 360, The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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