ALHIV Smartphone Game Study

NCT06913660 | Active Not Recruiting

• 2 other identifiers: STUDY000029745R33MH124200-04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hiv; AIDS; Adolescent Behavior; Treatment Compliance; Treatment Adherence; Reproductive Behavior; Sexual Behavior

Keywords

HIV; Smartphone Game

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Change in viral load (VL) from baseline

  Baseline, mid-point (around 4 months post-intervention), and endline (9 months post-intervention)

• Change in attendance at scheduled clinic visits

  Baseline, 9 months post-intervention

• Change in Retention in care

  Baseline, 9 months post-intervention

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

ACTIVE COMPARATOR

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

Interventions

MyGoals BEHAVIORAL

A smartphone game for ALHIV aged 15-21 yrs MyGoals includes 3 components: 1. A role-playing narrative in which all players make decisions for male and female characters navigating scenarios from adolescence and early adulthood. 2. A series of mini-games to reinforce knowledge, skills and related self-efficacy, explored in the narrative. 3. A metanarrative component, My Story, where players will create an avatar and set personal goals.

Intervention Arm

Standard of care BEHAVIORAL

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.

Also known as: Standard of care package

Control Arm

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

KEMRI Clinical Research Centre

Kisumu, 54840, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Adolescent Behavior; Patient Compliance; Treatment Adherence and Compliance; Reproductive Behavior; Sexual Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior; Patient Acceptance of Health Care; Health Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kate Winskell, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A cluster-randomized feasibility study, that involves clinic-level randomization

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 6, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)