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OpenTrials
Completed

NCT Number: NCT03775642

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.

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Key information

Conditions

Contraception Behavior Behavior Reproductive Behavior

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Epidemiology Training Unit

Kingston, Jamaica

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Video

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

Behavioral

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

Primary outcomes

  1. Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)

    Time frame: within 3 months of enrollment

    Based on survey question on use of the IUD (y/n) and implant (y/n)

Secondary outcomes

  1. Self-reported belief about IUD safety

    Time frame: 3 months after enrollment

    "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.

  2. Self-reported belief about implant safety

    Time frame: 3 months after enrollment

    "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. Self-reported attitudes toward LARC-related bleeding patterns

    Time frame: 3 months after enrollment

    "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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Epidemiology Research and Training Unit of the Jamaica Ministry of Health
  • FHI 360
  • The University of The West Indies

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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