A Mobile Phone Game to Prevent HIV Among Young Africans

This project will test the feasibility of an electronic game to prevent HIV among African preadolescents, delivered via inexpensive Android smart phones. In order to collect feasibility data for a future randomized controlled trial, this study involves the pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya, where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be carried out with the Kenya Medical Research Institute (KEMRI).

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Tumaini Mobile Phone Game

Detailed Description

This project will test the feasibility of an electronic game for preadolescents, delivered via inexpensive Android smart phones. The game is informed by socio-behavioral and pedagogical theories, evidence-based practice, and formative research on youth sexual culture in sub-Saharan Africa. It is designed to: educate young players, ages 11-14, about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV, sexually transmitted infections (STIs), and unintended pregnancy; challenge harmful gender norms and HIV stigma; and foster dialogue with parents and caregivers.

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Aged 11-14 at time of recruitment
• Resident in Nyanza region, Kenya
• Having basic literacy in English
• Only one child enrolled per family

Exclusion criteria:

• Aged <11 or >14 at time of recruitment
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tumaini Mobile Phone Game; Participants randomized to this arm will be invited to play the Tumaini game.	Behavioral: 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.
No Intervention: Standard of Care; Participants randomized to this arm will receive no intervention beyond the current standard of care for sexual education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Interested in Participating	To evaluate the feasibility of conducting a technology based intervention in a low resource area, the number of eligible individuals who were interested in participating after hearing about the study was examined. Letters were sent to 150 families inviting them to attend an informational meeting and 126 attended a meeting and were assess for eligibility.	Month 1
Time to Recruitment of 60 Participants	The number of days needed to recruit 60 participants.	Month 1
Number of Participants Lost to Follow Up	The number of participants who consented to participate but then later could not be reached prior to completing all study visits.	Duration of Study (Up to 4 Months)
Number of Participants Completing the Study	The number of participants who completed all study visits after providing consent are presented here.	Duration of Study (Up to 4 Months)
Number of Phones Returned	The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention.	Month 2
Number Reporting Game Was Very Fun	Game acceptability was assessed by asking participants how fun playing the game was. The number of participants reporting that the game was "very fun" are presented here.	Day 17 (post-intervention)
Number Reporting the Game is Valuable	The value of the game was assessed with several questions regarding how much the participants learned and how useful the information is. The number of participants reporting that they learned a lot, found the information very useful now, and found the information very useful for the future, are presented below.	Day 17 (post-intervention)
Number of Participants Feeling Very Safe	Personal safety associated with being in possession of the phone was assessed by the post-intervention survey. Phones provided for the intervention were set up so that all other features were blocked and only function the phone could perform was playing the game.	Day 17 (post-intervention)
Number of Participants Playing the Game	Participants were asked to play the game for at least one hour per day for 16 days. The number of participants who reported playing the game everyday and the number of participants who reported playing the game for an hour or more each time are presented here.	Day 17 (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knowledge	Knowledge measures will be assessed via Yes/No survey questions and will address puberty, HIV, sexually transmitted infections (STIs), pregnancy, condoms, and alcohol and drugs. Knowledge was assessed with 15 items and responses are coded as 0 or 1. Total scores range from 0 to 15, with higher scores indicating increased knowledge. A positive value for the change from baseline score indicates an increase in knowledge from the baseline assessment.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Change in Self-Efficacy	Self-efficacy was assessed via a 3-point Likert scale, and addressed self-efficacy to seek advice about puberty, sex, relationships; to communicate about protected sex; to reject peer, partner and adult pressure to engage in risk behaviors. Self-efficacy was assessed with 9 items which were scored as 0, 0.5 or 1. Total scores ranged from 0 to 9, with higher scores indicating increased self-efficacy. A positive value for the change from baseline score indicates an increase in self-efficacy since the baseline assessment.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Change in Risk Assessment	Risk assessment was assessed via a 3-point Likert scale, and addressed perceived risk of certain risk situations/behaviors and of contracting HIV. Risk is assessed with 4 items and responses are coded as 0, 0.5 or 1. Total scores range from 0 to 4, with higher scores indicating increased risk assessment. A positive value for the change from baseline score indicates an increase in assessing risky situations as risky.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Change in Behavioral Intention	Behavioral intention was assessed via Yes/No questions. The measure addressed intention to seek advice, to avoid risk situations, and to engage in health protective behaviors. Behavioral intention is assessed with 6 items that are scored as 0 or 1 and total scores range from 0 to 6. Higher scores in indicate more intention to partake in health protective behaviors and a positive value for the change from baseline score indicates a desirable change in intention.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Change in Future Orientation	Future orientation was assessed via a single multiple-choice question (Yes/No/Maybe) and addressed perceived locus of control. Response is coded as 0, 0.5, or 1 and higher scores indicate greater understanding of future locus of control. A positive value for the change from baseline score indicates a desirable change in scores.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Change in Perceived Social Norms	Perceived social norms were assessed via a 3-point Likert and addressed sex, gender, condoms, and HIV stigma. Social norms were assessed with 6 items that are scored as 0, 0.5, or 1. Total scores range from 0 to 6 with higher scores indicating perception of more desirable social norms. A positive value for the change from baseline scores indicates a desirable change.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
Change in Attitudes	Attitudes were assessed via 3-pt Likert survey questions relating to HIV stigma, condoms, sex, gender, and future orientation. Attitudes were assessed with 15 items and responses coded as 0, 0.5, or 1. Total scores ranged from 0 to 15, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score indicates an increase in desirable attitudes.	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH); Kenya Medical Research Institute
• Investigators: Principal Investigator: Kate Winskell, PhD, Emory University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): June 19, 2017
• Study Completion (Actual): June 19, 2017

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Feasibility; HIV prevention; Preadolescence; Mobile phone game
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: IRB00081150; 5R34MH106368 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No