JMIR Publications

ABSTRACT

Background:

Adolescents contribute slightly less than a third of all new HIV infections in sub-Saharan Africa. There is a need for more effective intervention approaches to help young adolescents safely navigate through adolescence and into adulthood. We are assessing the efficacy of Tumaini, a smartphone game designed to prevent HIV among young Africans. Against the background of COVID-19, meaningful alteration of the research protocol was necessary to ensure successful implementation, and retention of the study participants in ongoing research.

Objective:

The objective of our protocol is to: (1) determine if Tumaini delays sexual debut and increases condom use at first sex, and (2) determine whether it influences behavioral mediators of early and unprotected sex.

Methods:

Participants were recruited from Kisumu County, in Western Kenya. This study is a two-arm, individual-randomized controlled trial that enrolled 1,004 adolescents aged between 12 and 15 years. The intervention arm participants are playing Tumaini, while the control arm are provided with Brainilis, a commercially available control game. The study period will last 45 months. At baseline, participants in both arms completed a baseline survey and biological testing for HIV and HSV-2; participants will have annual gameplay sessions in years 1-3. They will also complete a total of 12 follow-up surveys. At endline, repeat biological testing will be conducted. Protocol adaptations were necessitated by the COVID-19 pandemic and implemented in accordance with local public health guidelines.

Results:

Participants were enrolled between October 2020 and November 2020. We plan to complete study procedures in September 2024. Enrolled participant sample was 50.1% female (n=499) and had a mean age of 14.0 years (SD=0.6 years).

Conclusions:

This ongoing research demonstrates that with appropriate revisions to planned protocol activities guided by the need to maintain study integrity, protect both study participants and staff, and adherence to IRB and local health authority guidelines, human subject research is possible in the context of a global pandemic. If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to pre-adolescents on safer sex, HIV prevention and effective life skills on a highly scalable, low cost and culturally adaptable platform. Clinical Trial: ClinicalTrials.gov (NCT04437667).