HIV-Prevention Smartphone Game Trial

NCT04437667 | Suspended

• 2 other identifiers: IRB001084041R01MH118982-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV

Keywords

HIV; Adolescents; Prevention; Sexually transmitted infections (STIs)

Outcome Measures

Primary Outcomes (12)

• Age at first sex

  Age at first sex encounter.

  Up to month 46

• Percentage of participants reporting condom use at first sex

  Percentage of participants reporting condom use at first sex

  Up to month 46

• Binary Risk outcome of "risk" vs "low risk"

  Binary outcome of "risk" group (experienced sexual debut during the study period without condom use at first sex) vs "low risk" group (not yet experienced sexual debut by the end of the study, or used a condom at sexual debut during the study period).

  Up to month 46

• Change in percentage of participants reporting recent sexual activity

  For participants reporting previous sexual intercourse, self-report of sexual intercourse since previous behavioral survey.

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

• Change in percentage of participants reporting recent condom use

  For participants reporting recent sexual activity, self-report of consistent condom use since previous behavioral survey.

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

• Change in number of sexual partners

  For participants reporting any past sexual activity, number of different sexual partners

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

• Change in percentage of participants with recent alcohol and drug use

  Percentage of participants that report recent alcohol and drug use.

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

• Change in knowledge

  Knowledge measures will be assessed via Yes/No survey questions and will address HIV, sexually transmitted infections (STIs), pregnancy, and condoms. Answers to knowledge questions will be coded as 0 or 1, with higher scores indicating more accurate knowledge. A positive value for the change from baseline score indicate an increase in knowledge from the baseline assessment.

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

• Change in self-efficacy

  Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy to use a condom correctly; to communicate with a partner about protected sex; to reject peer, partner, and adult pressure to engage in risk behaviors; and, for female participants, to manage menstruation. Self-efficacy will be scored on a 0-1 scale with higher scores indicating stronger self-efficacy. A positive value for the change from baseline score will indicate an increase in self-efficacy since the baseline assessment.

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

• Change in risk assessment

  Risk assessment will be assessed via a Likert scale, and address perceived risk of certain risk situations/behaviors. Risk items will be scored on a 0-1 scale, with higher scores indicating higher risk assessment. A positive value for the change from baseline score will indicate an increase in assessing risky situations as risky.

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

• Change in attitudes

  Attitudes will be assessed via Likert survey questions relating to puberty, HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score will indicate an increase in desirable attitudes.

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

• Change in behavioral intentions

  Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk situations and to engage in health protective behaviors. Behavioral intention items will be scored on a 0-1 scale with higher scores indicating more intention to partake in health protective behaviors and a positive value for the change from baseline score indicating an increase in intention to engage in health protective behaviors.

  Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46

Secondary Outcomes (3)

• Total length of gameplay

  Months 3,18, 28

• Number of participants with new HSV-2 diagnosis

  Months 1 and 46

• Number of participants with new HIV diagnosis

  Months 1 and 46

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Tumaini Mobile Phone Game

Control Arm

ACTIVE COMPARATOR

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.

Behavioral: Control Mobile Phone Game

Interventions

Tumaini Mobile Phone Game 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.

Intervention Arm

Control Mobile Phone Game 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).

Control Arm

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Related Publications (2)

• 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.

  PMID: 38388022 DERIVED

• 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.

  PMID: 35030090 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kate Winskell, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: October 12, 2020
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)