Evaluating What's My Method? in Barbados

Contraception Behavior Clinical Trial

Official title:

Evaluating the Impact of a Contraception Education Game: What's My Method? on Contraceptive Self-efficacy and Clinical Outcomes in Barbados

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307002
• Other study ID #: CAS_EB_2024
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Quinnipiac University
• Contact: Tiffany Jordan, MD
• Phone: 12468324827
• Email: tiffany[@]bfpaonline.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 30, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

Other:
• Playing a contraception education videogame
The WMM game is divided into three parts- a reproductive anatomy quiz ("Parts"), an interactive tool for education about each individual birth control method ("Methods"), and a section in which players help avatar couples choose the most effective method for them.

Locations

Country	Name	City	State
Barbados	Barbados Family Planning Association	Bridgetown	Saint Michaels

Sponsors (2)

Lead Sponsor	Collaborator
Quinnipiac University	Barbados Family Planning Association

Country where clinical trial is conducted

Barbados, 

References & Publications (11)

Bearak JM, Popinchalk A, Beavin C, Ganatra B, Moller AB, Tuncalp O, Alkema L. Country-specific estimates of unintended pregnancy and abortion incidence: a global comparative analysis of levels in 2015-2019. BMJ Glob Health. 2022 Mar;7(3):e007151. doi: 10.1136/bmjgh-2021-007151. — View Citation

Bertozzi E, Bertozzi-Villa A, Kulkarni P, Sridhar A. Collecting family planning intentions and providing reproductive health information using a tablet-based video game in India. Gates Open Res. 2018 Sep 7;2:20. doi: 10.12688/gatesopenres.12818.2. eCollection 2018. — View Citation

Chukwu E, Gilroy S, Addaquay K, Jones NN, Karimu VG, Garg L, Dickson KE. Formative Study of Mobile Phone Use for Family Planning Among Young People in Sierra Leone: Global Systematic Survey. JMIR Form Res. 2021 Nov 12;5(11):e23874. doi: 10.2196/23874. — View Citation

Dehlendorf C, Fitzpatrick J, Fox E, Holt K, Vittinghoff E, Reed R, Campora MP, Sokoloff A, Kuppermann M. Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. Am J Obstet Gynecol. 2019 Jun;220(6):565.e1-565.e12. doi: 10.1016/j.ajog.2019.02.015. Epub 2019 Feb 11. — View Citation

Fiellin LE, Hieftje KD, Pendergrass TM, Kyriakides TC, Duncan LR, Dziura JD, Sawyer BG, Mayes L, Crusto CA, Forsyth BW, Fiellin DA. Video Game Intervention for Sexual Risk Reduction in Minority Adolescents: Randomized Controlled Trial. J Med Internet Res. 2017 Sep 18;19(9):e314. doi: 10.2196/jmir.8148. — View Citation

Hamidi OP, Deimling T, Lehman E, Weisman C, Chuang C. High Self-Efficacy Is Associated with Prescription Contraceptive Use. Womens Health Issues. 2018 Nov-Dec;28(6):509-513. doi: 10.1016/j.whi.2018.04.006. Epub 2018 Aug 18. — View Citation

Laidlaw R, Dixon D, Morse T, Beattie TK, Kumwenda S, Mpemberera G. Using participatory methods to design an mHealth intervention for a low income country, a case study in Chikwawa, Malawi. BMC Med Inform Decis Mak. 2017 Jul 5;17(1):98. doi: 10.1186/s12911-017-0485-6. — View Citation

Lepore C, McNamara M, Miclette K, Vash-Margita A. Assessment of a Novel Interactive Website to Inform Adolescent and Young Adult Decision-Making about Contraception. J Pediatr Adolesc Gynecol. 2023 Nov 6:S1083-3188(23)00438-2. doi: 10.1016/j.jpag.2023.10.006. Online ahead of print. — View Citation

Stephenson J, Bailey JV, Gubijev A, D'Souza P, Oliver S, Blandford A, Hunter R, Shawe J, Rait G, Brima N, Copas A. An interactive website for informed contraception choice: randomised evaluation of Contraception Choices. Digit Health. 2020 Jun 26;6:2055207620936435. doi: 10.1177/2055207620936435. eCollection 2020 Jan-Dec. — View Citation

Wang H, Gupta S, Singhal A, Muttreja P, Singh S, Sharma P, Piterova A. An Artificial Intelligence Chatbot for Young People's Sexual and Reproductive Health in India (SnehAI): Instrumental Case Study. J Med Internet Res. 2022 Jan 3;24(1):e29969. doi: 10.2196/29969. — View Citation

Whiting-Collins L, Grenier L, Winch PJ, Tsui A, Donohue PK. Measuring contraceptive self-efficacy in sub-Saharan Africa: development and validation of the CSESSA scale in Kenya and Nigeria. Contracept X. 2020 Oct 9;2:100041. doi: 10.1016/j.conx.2020.100041. eCollection 2020. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive Self-Efficacy (CSE) score	Participants will complete a survey after their contraceptive counseling appointment	30-70 minutes
Secondary	Method Adoption	Participant will indicate if they desire a method and obtain or request an appointment to obtain said method	30-70 minutes
Secondary	Qualitative feedback on game intervention	Group that played the game will complete 4 question assessment of experience	50-90 minutes