A Mobile Phone Game to Prevent HIV Among Young Africans
NCT ID: NCT03054051
Last Updated: 2019-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-03-20
2017-06-19
Brief Summary
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Detailed Description
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The proposed feasibility test will be conducted in Western Kenya. Sixty preadolescents will be enrolled in the trial, 30 in the study arm and 30 in the control arm. The Kenya Medical Research Institute (KEMRI) has established community advisory boards (CABs) in Kisumu, which will be available to the proposed study.
Data collection will take place at KEMRI offices, health clinics, or in the meeting room of a local community-based organization (CBO). In addition, data on game-play will be automatically collected on mobile phones given to preadolescent study participants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Tumaini Mobile Phone Game
Participants randomized to this arm will be invited to play the Tumaini game.
Tumaini Mobile Phone Game
Tumaini is a scenario-based role-playing game application, optimized for use on low-cost Android smartphones. Participants will be invited to play the game for at least ten hours over a period of three weeks. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma and harmful gender norms; and promote parent-child dialogue.
Standard of Care
Participants randomized to this arm will receive no intervention beyond the current standard of care for sexual education.
No interventions assigned to this group
Interventions
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Tumaini Mobile Phone Game
Tumaini is a scenario-based role-playing game application, optimized for use on low-cost Android smartphones. Participants will be invited to play the game for at least ten hours over a period of three weeks. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma and harmful gender norms; and promote parent-child dialogue.
Eligibility Criteria
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Inclusion Criteria
* Resident in Nyanza region, Kenya
* Having basic literacy in English
* Only one child enrolled per family
Exclusion Criteria
* Not resident in Nyanza region, Kenya
* Without basic literacy in English
* Sibling to a child already enrolled in the study
* Participant in formative research to inform the study
11 Years
14 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Kenya Medical Research Institute
OTHER
Emory University
OTHER
Responsible Party
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Kate Winskell
Associate Professor
Principal Investigators
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Kate Winskell, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Kenya Medical Research Institute
Kisumu, , Kenya
Countries
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References
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Winskell K, Sabben G, Akelo V, Ondeng'e K, Obong'o C, Stephenson R, Warhol D, Mudhune V. A Smartphone Game-Based Intervention (Tumaini) to Prevent HIV Among Young Africans: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 1;6(8):e10482. doi: 10.2196/10482.
Sabben G, Akelo V, Mudhune V, Ondeng'e K, Ndivo R, Stephenson R, Winskell K. A Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Pilot Study of a Mobile Intervention. JMIR Res Protoc. 2019 Mar 27;8(3):e11209. doi: 10.2196/11209.
Sabben G, Mudhune V, Ondeng'e K, Odero I, Ndivo R, Akelo V, Winskell K. A Smartphone Game to Prevent HIV Among Young Africans (Tumaini): Assessing Intervention and Study Acceptability Among Adolescents and Their Parents in a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 May 21;7(5):e13049. doi: 10.2196/13049.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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IRB00081150
Identifier Type: -
Identifier Source: org_study_id
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