HIV-Prevention Smartphone Game Trial

Emory University

Status: Suspended

Conditions: HIV

Treatments: Behavioral: Control Mobile Phone Game; Behavioral: Tumaini Mobile Phone Game

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04437667

1R01MH118982-01 (U.S. NIH Grant/Contract)

IRB00108404

Details and patient eligibility

About

This project, funded by the National Institute of Mental Health, will test the efficacy of an electronic game to prevent HIV among African adolescents (aged 12-17), delivered via inexpensive Android smartphones. This study involves a sample of 912 young people and 500 of their parents in Kenya's former Nyanza province, where 11.4% of young women and 3% of men ages 15-24 are HIV-infected. This study will be carried out by Emory University and the Kenya Medical Research Institute (KEMRI).

Full description

The 912 study participants (youth ages 12-14) will be randomized to the intervention or control arm upon completion of the baseline survey. The assignments will be generated with the use of a pseudo-random-number generator with permuted blocks, used to ensure a sex-balanced and age-balanced assignment to each arm. All participants will be given a low-cost (<$40) Android phone on which the study game will be loaded. Intervention arm phones will have app for Tumaini programmed on them, while control arm phones will have a commercially available game to be determined prior to the start of the randomized clinical trial. Preference will be given to a game or other app with educational content, for example, a general knowledge quiz or strategy game. Each app will be standalone and not require data access or connection to the Internet to function. All participants will be invited to play their assigned game for at least 10 hours during the November-December school holiday. While we anticipate that access to smartphones will be widespread at time of roll-out of an efficacious game, this is not yet the case: for the purposes of this study, phones need to be provided in order to ensure consistency of technology and avoid SES bias. All other phone functions aside from the alarm, will be disabled for safety reasons. The game will automatically record the time spent playing and the choices made in the context of gameplay. When returning the phones, all participants will be asked to fill out a form identifying others with whom the game or app was shared and creators of each profile on their study phones.

In line with the preferences expressed by parents during the feasibility test, the phones will be provided to participants during the long November-December school holidays and collected at the end of the holiday. Providing there is no evidence of contamination, participants will (a) keep the phone throughout the long November-December school holiday; and (b) receive the phone, loaded with the game, again during the November-December holidays of the following years.

Enrollment: 1,000 patients

Sex: All

Ages: 12 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Adolescents, male and female, aged 12-14 at recruitment in Kisumu Town, Kenya (n=912)

Inclusion criteria:

• Aged 12-14 at time of enrollment
• Resident in Kisumu Town, Kenya
• Having basic English literacy (Grade 3-4 on the Flesch-Kincaid Reading Scale, assessed via a short listening and reading comprehension test at enrollment)
• Only one child per family
• Not previously enrolled in formative research or pilot testing of intervention or survey instruments

Exclusion criteria:

• Aged <12 or >14 at time of enrollment
• Not a resident of Kisumu Town, Kenya
• Not having basic English literacy
• Sibling to a child already enrolled in the study
• Previously involved in formative research or pilot testing of intervention or survey instruments

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Adolescents participants enrolled in the intervention arm will receive the intervention, Tumaini, loaded on a low-cost Android smartphone, during the long November-December school holidays for the first three years of the study.

Treatment:

Behavioral: Tumaini Mobile Phone Game

Control Arm

Active Comparator group

Description:

Adolescent participants enrolled in the control arm will receive a commercially available age- and language-appropriate educational game or knowledge quiz loaded on a study-provided low-cost Android smartphone.

Treatment:

Behavioral: Control Mobile Phone Game