Contraception BehaviorNCT06307002
Evaluating What's My Method? in Barbados
A study testing Playing a contraception education videogame in people with Contraception Behavior, run by Quinnipiac University at 1 site in Barbados.
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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- Playing a contraception education videogame
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBarbados
- Study dates
- 11 Mar 2024to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - English-speaking
- Capable of using a tablet
- Childbearing individuals
- Individuals/Couples seeking family planning counseling (one response collected per couple)
Who cannot join
- Unable to provide informed consent due to intellectual or physical impairment - Under the age of 18 unless accompanied by a parent
Trial locations and contacts
1 site in 1 country.
Barbados1 site
Barbados Family Planning Association
Bridgetown, Saint Michaels, BB11085
About this study
Official title: Evaluating the Impact of a Contraception Education Game: What's My Method? on Contraceptive Self-efficacy and Clinical Outcomes in Barbados
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.
Read the 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.
- Conditions
- Contraception Behavior
- Being tested
- Playing a contraception education videogame
- Keywords
- Contraceptive Self-efficacy, Reproductive Empowerment, Videogame
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playing a contraception education videogameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Playing a contraception education videogame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Self-Efficacy (CSE) score
Participants will complete a survey after their contraceptive counseling appointment
Measured: 30-70 minutes
Secondary outcomes (2)
Method Adoption
Participant will indicate if they desire a method and obtain or request an appointment to obtain said method
Measured: 30-70 minutes
Qualitative feedback on game intervention
Group that played the game will complete 4 question assessment of experience
Measured: 50-90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start11 Mar 2024
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quinnipiac University
- Sponsor type
- University, hospital or other
- Collaborators
- Barbados Family Planning Association
- Responsible party
- Principal investigator, Elena Bertozzi, Quinnipiac University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307002
- Sponsor's protocol ID
- CAS_EB_2024
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35332057Bertozzi 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.
PubMed 29984358Chukwu 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.
PubMed 34766908Dehlendorf 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.
PubMed 30763545Fiellin 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.
PubMed 28923788Hamidi 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.
PubMed 30131220Stephenson 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.
PubMed 32704380Laidlaw 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.
PubMed 28679428Lepore 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.
PubMed 37935279Wang 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.
PubMed 34982034Whiting-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.
PubMed 33145490
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Contraception Education Game: What's My Method? on Contraceptive Self-efficacy and Clinical Outcomes in Barbados
- ClinicalTrials.gov ID
- NCT06307002
- Acronym / sponsor ID
- CAS_EB_2024
- Conditions
- Contraception Behavior
- Keywords
- Contraceptive Self-efficacy, Reproductive Empowerment, Videogame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Quinnipiac UniversityUniversity, hospital or other
- Collaborators
- Barbados Family Planning Association
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Playing a contraception education videogameThe 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. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - English-speaking
- Capable of using a tablet
- Childbearing individuals
- Individuals/Couples seeking family planning counseling (one response collected per couple)
Key exclusion criteria (1 listed)
- Unable to provide informed consent due to intellectual or physical impairment - Under the age of 18 unless accompanied by a parent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Playing a contraception education videogameThe 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. | Other | WMM Arm |
Primary outcome
Contraceptive Self-Efficacy (CSE) score
Time frame: 30-70 minutes
Participants will complete a survey after their contraceptive counseling appointment
2 secondary outcomes
Method Adoption
Time frame: 30-70 minutes
Qualitative feedback on game intervention
Time frame: 50-90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background: PubMed 35332057Bearak 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.
- Background: PubMed 29984358Bertozzi 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.
- Background: PubMed 34766908Chukwu 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.
- Background: PubMed 30763545Dehlendorf 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.
- Background: PubMed 28923788Fiellin 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.
- Background: PubMed 30131220Hamidi 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.
- Background: PubMed 32704380Stephenson 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.
- Background: PubMed 28679428Laidlaw 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.
- Background: PubMed 37935279Lepore 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.
- Background: PubMed 34982034Wang 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.
- Background: PubMed 33145490Whiting-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playing a contraception education videogame in people with Contraception Behavior, run by Quinnipiac University at 1 site in Barbados.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Barbados. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Self-Efficacy (CSE) score (time frame: 30-70 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307002, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.