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Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03775642
Enrollment
225
Registered
2018-12-14
Start date
2018-11-21
Completion date
2019-09-05
Last updated
2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception Behavior

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.

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.

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.

BEHAVIORALControl video

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

Sponsors

FHI 360
CollaboratorOTHER
Epidemiology Research and Training Unit of the Jamaica Ministry of Health
CollaboratorUNKNOWN
The University of The West Indies
CollaboratorOTHER
Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)within 3 months of enrollmentBased on survey question on use of the IUD (y/n) and implant (y/n)

Secondary

MeasureTime frameDescription
Self-reported belief about IUD safety3 months after enrollmentDo 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.
Self-reported belief about implant safety3 months after enrollmentDo 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.
Self-reported attitudes toward LARC-related bleeding patterns3 months after enrollmentHow 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

Countries

Jamaica

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026