Clinical trial NCT03054051: A Mobile Phone Game to Prevent HIV Among Young Africans
Official title: A Mobile Phone Game to Prevent HIV Among Young Africans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV prevention
Preadolescence
Mobile phone game
Feasibility
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kenya Medical Research Institute
First posted: 2017-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project will test the feasibility of an electronic game to prevent HIV among African preadolescents, delivered via inexpensive Android smart phones. In order to collect feasibility data for a future randomized controlled trial, this study involves the pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya, where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be carried out with the Kenya Medical Research Institute (KEMRI).

Detailed description: This project will test the feasibility of an electronic game for preadolescents, delivered via inexpensive Android smart phones. The game is informed by socio-behavioral and pedagogical theories, evidence-based practice, and formative research on youth sexual culture in sub-Saharan Africa. It is designed to: educate young players, ages 11-14, about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV, sexually transmitted infections (STIs), and unintended pregnancy; challenge harmful gender norms and HIV stigma; and foster dialogue with parents and caregivers.

The proposed feasibility test will be conducted in Western Kenya. Sixty preadolescents will be enrolled in the trial, 30 in the study arm and 30 in the control arm. The Kenya Medical Research Institute (KEMRI) has established community advisory boards (CABs) in Kisumu, which will be available to the proposed study.

Data collection will take place at KEMRI offices, health clinics, or in the meeting room of a local community-based organization (CBO). In addition, data on game-play will be automatically collected on mobile phones given to preadolescent study participants.

Eligibility criteria: Inclusion criteria:

* Aged 11-14 at time of recruitment
* Resident in Nyanza region, Kenya
* Having basic literacy in English
* Only one child enrolled per family

Exclusion criteria:

* Aged \<11 or \>14 at time of recruitment
* Not resident in Nyanza region, Kenya
* Without basic literacy in English
* Sibling to a child already enrolled in the study
* Participant in formative research to inform the study

Primary outcomes:
measure: Number Interested in Participating
timeFrame: Month 1
measure: Time to Recruitment of 60 Participants
timeFrame: Month 1
measure: Number of Participants Lost to Follow Up
timeFrame: Duration of Study (Up to 4 Months)
measure: Number of Participants Completing the Study
timeFrame: Duration of Study (Up to 4 Months)
measure: Number of Phones Returned
timeFrame: Month 2
measure: Number Reporting Game Was Very Fun
timeFrame: Day 17 (post-intervention)
measure: Number Reporting the Game is Valuable
timeFrame: Day 17 (post-intervention)
measure: Number of Participants Feeling Very Safe
timeFrame: Day 17 (post-intervention)
measure: Number of Participants Playing the Game
timeFrame: Day 17 (post-intervention)
Secondary outcomes:
measure: Change in Knowledge
timeFrame: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
measure: Change in Self-Efficacy
timeFrame: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
measure: Change in Risk Assessment
timeFrame: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
measure: Change in Behavioral Intention
timeFrame: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
measure: Change in Future Orientation
timeFrame: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
measure: Change in Perceived Social Norms
timeFrame: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
measure: Change in Attitudes
timeFrame: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention
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: Winskell K, Sabben G, Akelo V, Ondeng'e K, Obong'o C, Stephenson R, Warhol D, Mudhune V. A Smartphone Game-Based Intervention (Tumaini) to Prevent HIV Among Young Africans: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 1;6(8):e10482. doi: 10.2196/10482.
citation: Sabben G, Akelo V, Mudhune V, Ondeng'e K, Ndivo R, Stephenson R, Winskell K. A Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Pilot Study of a Mobile Intervention. JMIR Res Protoc. 2019 Mar 27;8(3):e11209. doi: 10.2196/11209.
citation: Sabben G, Mudhune V, Ondeng'e K, Odero I, Ndivo R, Akelo V, Winskell K. A Smartphone Game to Prevent HIV Among Young Africans (Tumaini): Assessing Intervention and Study Acceptability Among Adolescents and Their Parents in a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 May 21;7(5):e13049. doi: 10.2196/13049.