Clinical trial NCT06307002: Evaluating What's My Method? in Barbados
Official title: Evaluating the Impact of a Contraception Education Game: What's My Method? on Contraceptive Self-efficacy and Clinical Outcomes in Barbados
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Keywords: Contraceptive Self-efficacy
Reproductive Empowerment
Videogame
Lead sponsor: Quinnipiac University
Sponsor class: OTHER
Collaborators: name: Barbados Family Planning Association
First posted: 2024-03-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 2 arm randomized controlled trial comparing standard of care (SOC) counseling alone to What's My Method? (WMM) gameplay in addition to SOC.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to measure the impact of the What's My Method game on participants' sense of agency, education, and empowerment around contraceptive decision-making. Patients receiving standard of care contraceptive counseling will be compared to those who play the game in addition to counseling.

Detailed description: Contraceptive self-care has been identified by the WHO as critical to achieving milestones for female empowerment and well-being. This focus reflects a shift in global public health attitudes regarding contraceptive provision from a top-down approach, where childbearing persons receive directives from medical providers, towards an approach that encourages self-determination and individual agency. Implementing contraceptive counseling and education through the lens of reproductive empowerment requires that the focus of the intervention be on the childbearing persons and their needs. There is a clear need for improvement in contraceptive counseling in Barbados. As per the United Nations dashboard, the modern contraceptive prevalence rate is 49% and providers report that abortion is often used as birth control.

Digital health interventions have been validated as successful high-impact practices to support healthy reproductive behaviors. These interventions include SMS campaigns , artificial intelligence-based chatbots, and interactive websites which provide information and offer tools to help choose appropriate methods. These studies demonstrate that digital media are an effective way to reach the target audience and communicate information about reproductive health. Barbadian clinics have not yet integrated digital technology to support CC; they rely on pamphlets and posters for information dissemination.

This study seeks assess the impact of supplementing SOC counseling with a digital game that provides detailed information about family planning methods, their benefits and side effects. The information is communicated through using animations and images and reinforced through experimentation and context.

Eligibility criteria: Inclusion Criteria:

* - English-speaking
* Capable of using a tablet
* Childbearing individuals
* Individuals/Couples seeking family planning counseling (one response collected per couple)

Exclusion Criteria:

* Unable to provide informed consent due to intellectual or physical impairment - Under the age of 18 unless accompanied by a parent

Primary outcomes:
measure: Contraceptive Self-Efficacy (CSE) score
timeFrame: 30-70 minutes
Secondary outcomes:
measure: Method Adoption
timeFrame: 30-70 minutes
measure: Qualitative feedback on game intervention
timeFrame: 50-90 minutes
Other outcomes:
Locations:
city: Bridgetown
country: Barbados
facility: Barbados Family Planning Association
state: Saint Michaels
Study officials:
References:
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