HIV-Prevention Smartphone Game Trial

NCT ID: NCT04437667

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2028-08-31

Brief Summary

This project, funded by the National Institute of Mental Health, will test the efficacy of an electronic game to prevent HIV among African adolescents (aged 12-17), delivered via inexpensive Android smartphones. This study involves a sample of 912 young people and 500 of their parents in Kenya's former Nyanza province, where 11.4% of young women and 3% of men ages 15-24 are HIV-infected. This study will be carried out by Emory University and the Kenya Medical Research Institute (KEMRI).

Detailed Description

The 912 study participants (youth ages 12-14) will be randomized to the intervention or control arm upon completion of the baseline survey. The assignments will be generated with the use of a pseudo-random-number generator with permuted blocks, used to ensure a sex-balanced and age-balanced assignment to each arm. All participants will be given a low-cost (<$40) Android phone on which the study game will be loaded. Intervention arm phones will have app for Tumaini programmed on them, while control arm phones will have a commercially available game to be determined prior to the start of the randomized clinical trial. Preference will be given to a game or other app with educational content, for example, a general knowledge quiz or strategy game. Each app will be standalone and not require data access or connection to the Internet to function. All participants will be invited to play their assigned game for at least 10 hours during the November-December school holiday. While we anticipate that access to smartphones will be widespread at time of roll-out of an efficacious game, this is not yet the case: for the purposes of this study, phones need to be provided in order to ensure consistency of technology and avoid SES bias. All other phone functions aside from the alarm, will be disabled for safety reasons. The game will automatically record the time spent playing and the choices made in the context of gameplay. When returning the phones, all participants will be asked to fill out a form identifying others with whom the game or app was shared and creators of each profile on their study phones.

In line with the preferences expressed by parents during the feasibility test, the phones will be provided to participants during the long November-December school holidays and collected at the end of the holiday. Providing there is no evidence of contamination, participants will (a) keep the phone throughout the long November-December school holiday; and (b) receive the phone, loaded with the game, again during the November-December holidays of the following years.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Adolescents participants enrolled in the intervention arm will receive the intervention, Tumaini, loaded on a low-cost Android smartphone, during the long November-December school holidays for the first three years of the study.

Group Type: EXPERIMENTAL

Tumaini Mobile Phone Game

Intervention Type: BEHAVIORAL

Tumaini is a scenario-based role-playing game application. Participants will be instructed to engage in a minimum of 10 hours of gameplay over the holiday period each year. The game will automatically collect for analysis data related to participants' in-game behavior, e.g. time spent playing, scores on knowledge-based mini-games, choices made in the narrative game, components to which the player was exposed. 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 promote parent-child dialogue.

Control Arm

Adolescent participants enrolled in the control arm will receive a commercially available age- and language-appropriate educational game or knowledge quiz loaded on a study-provided low-cost Android smartphone.

Group Type: ACTIVE_COMPARATOR

Control Mobile Phone Game

Intervention Type: BEHAVIORAL

Independent gameplay of control game. Total respondent burden: participants will be invited to engage in at least 10 hours of gameplay during each long school holiday (November-December).

Interventions

Tumaini Mobile Phone Game

Tumaini is a scenario-based role-playing game application. Participants will be instructed to engage in a minimum of 10 hours of gameplay over the holiday period each year. The game will automatically collect for analysis data related to participants' in-game behavior, e.g. time spent playing, scores on knowledge-based mini-games, choices made in the narrative game, components to which the player was exposed. 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 promote parent-child dialogue.

Intervention Type: BEHAVIORAL

Control Mobile Phone Game

Independent gameplay of control game. Total respondent burden: participants will be invited to engage in at least 10 hours of gameplay during each long school holiday (November-December).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 12-14 at time of enrollment
• Resident in Kisumu Town, Kenya
• Having basic English literacy (Grade 3-4 on the Flesch-Kincaid Reading Scale, assessed via a short listening and reading comprehension test at enrollment)
• Only one child per family
• Not previously enrolled in formative research or pilot testing of intervention or survey instruments

Exclusion Criteria

• Aged <12 or >14 at time of enrollment
• Not a resident of Kisumu Town, Kenya
• Not having basic English literacy
• Sibling to a child already enrolled in the study
• Previously involved in formative research or pilot testing of intervention or survey instruments

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Kate Winskell

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kate Winskell, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Kenya Medical Research Institute

Kisumu, , Kenya

Countries

Kenya

References

Mudhune V, Winskell K, Bednarczyk RA, Ondenge K, Mbeda C, Kerubo E, Ndivo R, Arego J, Morales M, Halliburton B, Sabben G. Sexual behaviour among Kenyan adolescents enrolled in an efficacy trial of a smartphone game to prevent HIV: a cross-sectional analysis of baseline data. SAHARA J. 2024 Dec;21(1):2320188. doi: 10.1080/17290376.2024.2320188. Epub 2024 Feb 22.

Reference Type: DERIVED

PMID: 38388022 (View on PubMed)

Mudhune V, Sabben G, Ondenge K, Mbeda C, Morales M, Lyles RH, Arego J, Ndivo R, Bednarczyk RA, Komro K, Winskell K. The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19. JMIR Res Protoc. 2022 Mar 3;11(3):e35117. doi: 10.2196/35117.

Reference Type: DERIVED

PMID: 35030090 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01MH118982-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00108404

Identifier Type: -

Identifier Source: org_study_id