Adolescent Behavior, AIDS, Hiv, Reproductive Behavior, Sexual Behavior, Treatment Adherence, Treatment Compliance
Conditions
Keywords
HIV, Smartphone Game
Brief summary
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).
Detailed description
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).
Interventions
BEHAVIORALMyGoals
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.
BEHAVIORALStandard of care
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.
Sponsors
Emory University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A cluster-randomized feasibility study, that involves clinic-level randomization
Eligibility
Sex/Gender
ALL
Age
15 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
Adolescents, male and female, aged 15-21 in Kisumu County (n=120) Inclusion criteria: * Aged 15-21 at time of recruitment * Diagnosed with HIV and aware of HIV status * Initiated ART at least 6 months prior * Accesses HIV-related care at intervention arm CCC * VL above 50 copies/ml at last test, with last test conducted within 12 months prior to recruitment date
Exclusion criteria
* Does not have basic literacy in English (Grade 3-4 on the Flesch-Kincaid Reading Scale) * Sibling to an adolescent already enrolled in study * Sibling to adolescent that participated in formative research * Participant in formative research to inform study * Participant in any Tumaini game activities * Enrolled in boarding school * Last recorded viral load test \>12 months prior to recruitment date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in knowledge | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention | 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. |
| Change in attitudes | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention | 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. |
| Change in behavioral intentions | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention | 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. |
| Change in self-efficacy | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention | 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. |
| Change in game acceptability | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention | 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. |
| Change in game immersion | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention | 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. |
| Change in game continued use | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention | 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. |
| Change in game demand | Baseline, 9 months post-intervention | 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. |
| Change in game safety | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in viral load (VL) from baseline | Baseline, mid-point (around 4 months post-intervention), and endline (9 months post-intervention) | VL will be assessed as "undetectable" (\<50 copies/ml) or "detectable". |
| Change in attendance at scheduled clinic visits | Baseline, 9 months post-intervention | Participant medical records (MR) will be used to review attendance. |
| Change in Retention in care | Baseline, 9 months post-intervention | 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". |
Countries
Kenya
Contacts
PRINCIPAL_INVESTIGATORKate Winskell, PhD
Emory University
Outcome results
None listed