NCT06307002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2024

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

March 5, 2024

Last Update Submit

January 14, 2025

Conditions

Keywords

Contraceptive Self-efficacyReproductive EmpowermentVideogame

Outcome Measures

Primary Outcomes (1)

  • Contraceptive Self-Efficacy (CSE) score

    Participants will complete a survey after their contraceptive counseling appointment

    30-70 minutes

Secondary Outcomes (2)

  • Method Adoption

    30-70 minutes

  • Qualitative feedback on game intervention

    50-90 minutes

Study Arms (2)

Control Arm

NO INTERVENTION

The control group will receive SOC counseling, defined as the current practice at our partner institutions. Patients presenting for contraceptive counseling are given informational pamphlets and have the option to review additional materials posted on the clinic walls and on a rotating slide deck on a digital screen. During their counseling session with a provider, they review eligible methods and can make a decision about whether or not to adopt a method, and to select and initiate the contraception of their choice.

WMM Arm

EXPERIMENTAL

The intervention group will be provided with a tablet loaded with the WMM game which will be played in the waiting room prior to their visit. They will then receive SOC counseling, defined as the current practice at our partner institutions. Patients presenting for contraceptive counseling are given informational pamphlets and have the option to review additional materials posted on the clinic walls and on a rotating slide deck on a digital screen. During their counseling session with a provider, they review eligible methods and can make a decision about whether or not to adopt a method, and to select and initiate the contraception of their choice.

Other: Playing a contraception education videogame

Interventions

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.

WMM Arm

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPersons who can become pregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbados Family Planning Association

Bridgetown, Saint Michaels, BB11085, Barbados

Location

Related 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.

    PMID: 35332057BACKGROUND
  • 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.

    PMID: 29984358BACKGROUND
  • 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.

    PMID: 34766908BACKGROUND
  • 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.

    PMID: 30763545BACKGROUND
  • 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.

    PMID: 28923788BACKGROUND
  • 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.

    PMID: 30131220BACKGROUND
  • 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.

    PMID: 32704380BACKGROUND
  • 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.

    PMID: 28679428BACKGROUND
  • 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. 2024 Apr;37(2):149-155. doi: 10.1016/j.jpag.2023.10.006. Epub 2023 Nov 6.

    PMID: 37935279BACKGROUND
  • 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.

    PMID: 34982034BACKGROUND
  • 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.

    PMID: 33145490BACKGROUND

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of Game Design & Development

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

March 11, 2024

Primary Completion

November 13, 2024

Study Completion

November 13, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Participant identifying information will not be collected as part of the study. Study data (scores on surveys, rate of method adoption) will be posted on a publicly available shared repository for use by other researchers.

Shared Documents
CSR, ANALYTIC CODE
Time Frame
within 3 months of publication.
Access Criteria
Data already collected is available at the Center for Open Science
More information

Locations