Clinical trial NCT04437667: HIV-Prevention Smartphone Game Trial
Official title: Efficacy Trial for a Smartphone Game to Prevent HIV Among Young Africans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Keywords: HIV
Adolescents
Prevention
Sexually transmitted infections (STIs)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kenya Medical Research Institute
First posted: 2020-06-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Age at first sex
timeFrame: Up to month 46
measure: Percentage of participants reporting condom use at first sex
timeFrame: Up to month 46
measure: Binary Risk outcome of "risk" vs "low risk"
timeFrame: Up to month 46
measure: Change in percentage of participants reporting recent sexual activity
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
measure: Change in percentage of participants reporting recent condom use
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
measure: Change in number of sexual partners
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
measure: Change in percentage of participants with recent alcohol and drug use
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
measure: Change in knowledge
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
measure: Change in self-efficacy
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
measure: Change in risk assessment
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
measure: Change in attitudes
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
measure: Change in behavioral intentions
timeFrame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Secondary outcomes:
measure: Total length of gameplay
timeFrame: Months 3,18, 28
measure: Number of participants with new HSV-2 diagnosis
timeFrame: Months 1 and 46
measure: Number of participants with new HIV diagnosis
timeFrame: Months 1 and 46
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: Emory University
name: Kate Winskell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mudhune V, Sabben G, Ondenge K, Mbeda C, Morales M, Lyles RH, Arego J, Ndivo R, Bednarczyk RA, Komro K, Winskell K. The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19. JMIR Res Protoc. 2022 Mar 3;11(3):e35117. doi: 10.2196/35117.