Clinical trial NCT06913660: ALHIV Smartphone Game Study
Official title: A Smartphone Game to Increase Engagement in Care Among African Adolescents Living With HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hiv
AIDS
Adolescent Behavior
Treatment Compliance
Treatment Adherence
Reproductive Behavior
Sexual Behavior
Keywords: HIV
Smartphone Game
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-06
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized feasibility study, that involves clinic-level randomization
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in knowledge
timeFrame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
measure: Change in attitudes
timeFrame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
measure: Change in behavioral intentions
timeFrame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
measure: Change in self-efficacy
timeFrame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
measure: Change in game acceptability
timeFrame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
measure: Change in game immersion
timeFrame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
measure: Change in game continued use
timeFrame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
measure: Change in game demand
timeFrame: Baseline, 9 months post-intervention
measure: Change in game safety
timeFrame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Secondary outcomes:
measure: Change in viral load (VL) from baseline
timeFrame: Baseline, mid-point (around 4 months post-intervention), and endline (9 months post-intervention)
measure: Change in attendance at scheduled clinic visits
timeFrame: Baseline, 9 months post-intervention
measure: Change in Retention in care
timeFrame: Baseline, 9 months post-intervention
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: KEMRI Clinical Research Centre
Study officials:
affiliation: Emory University
name: Kate Winskell, PhD
role: PRINCIPAL_INVESTIGATOR
References: