ALHIV Smartphone Game Study

Emory University

Status: Active, not recruiting

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

Treatments: Behavioral: Standard of care; Behavioral: MyGoals

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06913660

STUDY00002974

5R33MH124200-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 15 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: MyGoals

Control Arm

Active Comparator group

Description:

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).

Treatment:

Behavioral: Standard of care