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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
120
A smartphone game for ALHIV aged 15-21 yrs MyGoals includes 3 components: 1. A role-playing narrative in which all players make decisions for male and female characters navigating scenarios from adolescence and early adulthood. 2. A series of mini-games to reinforce knowledge, skills and related self-efficacy, explored in the narrative. 3. A metanarrative component, My Story, where players will create an avatar and set personal goals.
A minimum standard of care package will be identified prior to identification and recruitment of CCCs to ensure a comparable and adequate level of care is being offered to all control participants, since implementation of the range of support and care strategies recommended by the Kenya Ministry of Health differs by clinic.
KEMRI Clinical Research Centre
Kisumu, Kenya
Change in knowledge
Knowledge measures will be assessed via Yes/No//I do not know survey questions and will address ART (antiretroviral therapy), HIV, sexually transmitted infections (STIs), pregnancy, and condoms. Answers to knowledge questions will be coded as 0 or 1, with higher scores indicating more accurate knowledge. Total possible score range is 0-14. A positive value for the change from baseline score will indicate an increase in knowledge from the baseline assessment.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in attitudes
Attitudes will be assessed via Likert survey questions relating to HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. Total possible score range is 0-14. A positive value for the change from baseline score will indicate an increase in desirable attitudes.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in behavioral intentions
Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk and to engage in health protective behaviors. Behavioral intention items will be scored on a 0-1 scale with higher scores indicating more intention to partake in health protective behaviors and a positive value for the change from baseline score indicating an increase in intention to engage in health protective behaviors. Total possible score range is 0-9.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in self-efficacy
Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy for condom use; to communicate with a partner about protected sex; to adhere to medication; to fully engage in care and to disclose their HIV status. Self-efficacy will be scored on a 0-1 scale with higher scores indicating stronger self-efficacy. A positive value for the change from baseline score will indicate an increase in self-efficacy since the baseline assessment. Total possible score range is 0-23.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in game acceptability
Acceptability will be assessed among intervention-arm participants via Likert scale questions. Acceptability will be scored on a 0-1 scale with higher scores indicating higher acceptability. Total possible score range is 0-12, with higher score correlating with better study outcome.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in game immersion
Immersion will be assessed among intervention-arm participants via Likert scale questions and focus on identification, transportation, and immersion. Immersion items will be scored on a 0-1 scale with higher scores indicating stronger immersion. Total possible score range is 0-18. Higher score correlates with better study outcome.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in game continued use
Continued use of the intervention over the course of the study will be assessed among intervention-arm participants via both self-report survey questions and analysis of paradata. Survey items will assess self-reported use of the game in hours at each follow-up study timepoint. Paradata analysis will calculate time in hours spent on the app for each intervention-arm participant.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in game demand
Demand for ongoing access to the intervention following study endline will be assessed among intervention-arm participants via Likert scale questions. Demand items will be scored on a 0-1 scale with higher scores indicating stronger demand. Total possible score range is 0-2, and higher score correlates with better study outcome.
Time frame: Baseline, 9 months post-intervention
Change in game safety
Participants' perceived safety while in possession of the phone and app will be assess among intervention-arm participants via Likert scale questions. These will focus on physical safety as well as comfort with having an HIV-related app on the study phone. Safety items will be scored on a 0-1 scale with higher scores indicating higher perceived safety. Total possible score range is 0-4, and higher score correlates with better study outcome.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Change in viral load (VL) from baseline
VL will be assessed as "undetectable" (\<50 copies/ml) or "detectable".
Time frame: Baseline, mid-point (around 4 months post-intervention), and endline (9 months post-intervention)
Change in attendance at scheduled clinic visits
Participant medical records (MR) will be used to review attendance.
Time frame: Baseline, 9 months post-intervention
Change in Retention in care
Retention in care will be assessed as "disengaged" (has missed the last scheduled appointment and over half of all scheduled appointment within the previous study period) or "engaged".
Time frame: Baseline, 9 months post-intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.