ALHIV Smartphone Game Study

NCT ID: NCT06913660

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2026-07-31

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).

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).

Conditions

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

MyGoals

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: 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.

Interventions

MyGoals

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 Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Standard of care package

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

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

KEMRI Clinical Research Centre

Kisumu, , Kenya

Countries

Kenya

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

5R33MH124200-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002974

Identifier Type: -

Identifier Source: org_study_id