An interventional study of MyGoals and Standard of care in Hiv, AIDS and Adolescent Behavior, sponsored by Emory University. Completed at 1 site in Kenya. Open to participants aged 15 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Emory University · Not applicable, Interventional, and Other
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).
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 120 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adolescents, male and female, aged 15-21 in Kisumu County (n=120)
Inclusion criteria:
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention is an Android smartphone-based interactive narrative-driven game called MyGoals. Participants will be instructed to play the game for at least 30 minutes for 5 days per week for the first 6 weeks and as desired thereafter.
Behavioral: MyGoals
Control-arm participants will receive the current standard of care offered at their CCC (i.e. HIV care management support and counselling received at the CCC).
Behavioral: Standard of care
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.
Also known as: Standard of care package
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome →