ALHIV Smartphone Game Study

A Smartphone Game to Increase Engagement in Care Among African Adolescents Living With HIV

This is a cluster-randomized controlled trial that aims to conduct comprehensive feasibility testing of a smartphone game in a sample of 120 adolescents living with HIV (ALHIV) ages 15-21 in Kisumu, Kenya, to determine whether the game influences behavioral mediators of engagement in care and sexual risk avoidance and reduction (including knowledge, attitudes, behavioral intentions, and self-efficacy).

Study Overview

• Status: Active, not recruiting
• Conditions: Hiv; Sexual Behavior; Treatment Adherence; Adolescent Behavior; Reproductive Behavior; AIDS; Treatment Compliance
• Intervention / Treatment: Behavioral: Standard of care; Behavioral: MyGoals

Detailed Description

This is a cluster-randomized feasibility study that will involve clinic-level randomization of 120 ALHIV participants (12 from each of 10 clinical centers). Participants will either use the intervention (a smartphone game) or continue standard treatment and support for HIV. Participants will complete 5 surveys about behaviors, attitudes, knowledge, and self-efficacy relating to engagement in care, ART adherence, and sexual and reproductive health. They will also have blood drawn 3 times to measure their HIV viral load. Intervention-arm participants will also complete app experience surveys. A sample of intervention-arm participants will be invited to provide feedback on their experience in interviews (n=10) and/or focus groups (n=30).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya, 54840
    • KEMRI Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Adolescents, male and female, aged 15-21 in Kisumu County (n=120)

Inclusion criteria:

• Aged 15-21 at time of recruitment
• Diagnosed with HIV and aware of HIV status
• Initiated ART at least 6 months prior
• Accesses HIV-related care at intervention arm CCC
• VL above 50 copies/ml at last test, with last test conducted within 12 months prior to recruitment date

Exclusion criteria

• Does not have basic literacy in English (Grade 3-4 on the Flesch-Kincaid Reading Scale)
• Sibling to an adolescent already enrolled in study
• Sibling to adolescent that participated in formative research
• Participant in formative research to inform study
• Participant in any Tumaini game activities
• Enrolled in boarding school
• Last recorded viral load test >12 months prior to recruitment date

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
Active Comparator: Control Arm; Control-arm participants will receive the current standard of care offered at their CCC (i.e. HIV care management support and counselling received at the CCC).	Behavioral: Standard of care; A minimum standard of care package will be identified prior to identification and recruitment of CCCs to ensure a comparable and adequate level of care is being offered to all control participants, since implementation of the range of support and care strategies recommended by the Kenya Ministry of Health differs by clinic.; Other Names: Standard of care package
Experimental: Intervention Arm; The intervention is an Android smartphone-based interactive narrative-driven game called MyGoals. Participants will be instructed to play the game for at least 30 minutes for 5 days per week for the first 6 weeks and as desired thereafter.	Behavioral: MyGoals; A smartphone game for ALHIV aged 15-21 yrs MyGoals includes 3 components: A role-playing narrative in which all players make decisions for male and female characters navigating scenarios from adolescence and early adulthood.; A series of mini-games to reinforce knowledge, skills and related self-efficacy, explored in the narrative.; A metanarrative component, My Story, where players will create an avatar and set personal goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge	Knowledge measures will be assessed via Yes/No//I do not know survey questions and will address ART (antiretroviral therapy), 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. Total possible score range is 0-14. A positive value for the change from baseline score will indicate an increase in knowledge from the baseline assessment.	Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in attitudes	Attitudes will be assessed via Likert survey questions relating to HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. Total possible score range is 0-14. A positive value for the change from baseline score will indicate an increase in desirable attitudes.	Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in behavioral intentions	Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk 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. Total possible score range is 0-9.	Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in self-efficacy	Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy for condom use; to communicate with a partner about protected sex; to adhere to medication; to fully engage in care and to disclose their HIV status. 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. Total possible score range is 0-23.	Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in game acceptability	Acceptability will be assessed among intervention-arm participants via Likert scale questions. Acceptability will be scored on a 0-1 scale with higher scores indicating higher acceptability. Total possible score range is 0-12, with higher score correlating with better study outcome.	Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in game immersion	Immersion will be assessed among intervention-arm participants via Likert scale questions and focus on identification, transportation, and immersion. Immersion items will be scored on a 0-1 scale with higher scores indicating stronger immersion. Total possible score range is 0-18. Higher score correlates with better study outcome.	Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in game continued use	Continued use of the intervention over the course of the study will be assessed among intervention-arm participants via both self-report survey questions and analysis of paradata. Survey items will assess self-reported use of the game in hours at each follow-up study timepoint. Paradata analysis will calculate time in hours spent on the app for each intervention-arm participant.	Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in game demand	Demand for ongoing access to the intervention following study endline will be assessed among intervention-arm participants via Likert scale questions. Demand items will be scored on a 0-1 scale with higher scores indicating stronger demand. Total possible score range is 0-2, and higher score correlates with better study outcome.	Baseline, 9 months post-intervention
Change in game safety	Participants' perceived safety while in possession of the phone and app will be assess among intervention-arm participants via Likert scale questions. These will focus on physical safety as well as comfort with having an HIV-related app on the study phone. Safety items will be scored on a 0-1 scale with higher scores indicating higher perceived safety. Total possible score range is 0-4, and higher score correlates with better study outcome.	Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in attendance at scheduled clinic visits	Participant medical records (MR) will be used to review attendance.	Baseline, 9 months post-intervention
Change in Retention in care	Retention in care will be assessed as "disengaged" (has missed the last scheduled appointment and over half of all scheduled appointment within the previous study period) or "engaged".	Baseline, 9 months post-intervention
Change in viral load (VL) from baseline	VL will be assessed as "undetectable" (<50 copies/ml) or "detectable".	Baseline, mid-point (around 4 months post-intervention), and endline (9 months post-intervention)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Smartphone Game
• Other Study ID Numbers: STUDY00002974; 5R33MH124200-04 (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
• product manufactured in and exported from the U.S.: No