HivNCT06913660
ALHIV Smartphone Game Study
A study testing MyGoals in people with Hiv and AIDS, run by Emory University at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- Hiv, AIDS, Adolescent Behavior
- What is being tested?
- MyGoals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteKenya
- Study dates
- 7 Apr 2025to 7 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Smartphone Game to Increase Engagement in Care Among African Adolescents Living With HIV
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).
Read the 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).
- Conditions
- Hiv, AIDS, Adolescent Behavior, Treatment Compliance, Treatment Adherence, Reproductive Behavior
- Being tested
- MyGoals, Standard of care
- Keywords
- HIV, Smartphone Game
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Adolescent Behavior, Patient Compliance, Treatment Adherence and Compliance, Reproductive Behavior, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyGoalsBehavioural
A smartphone game for ALHIV aged 15-21 yrs
MyGoals includes 3 components:
- A role-playing narrative in which all players make decisions for male and female characters navigating scenarios from adolescence and early adulthood.
- A series of mini-games to reinforce knowledge, skills and related self-efficacy, explored in the narrative.
- A metanarrative component, My Story, where players will create an avatar and set personal goals.
Standard of careBehavioural
Also called Standard of care package
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: MyGoals |
| Control Arm | Active comparator | 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). Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention
Secondary outcomes (3)
Change in viral load (VL) from baseline
VL will be assessed as "undetectable" (<50 copies/ml) or "detectable".
Measured: 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.
Measured: 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".
Measured: Baseline, 9 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start7 Apr 2025
- Primary completion7 Mar 2026
- Study completion7 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized feasibility study, that involves clinic-level randomization
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kate Winskell, Emory University
- Investigators
- Kate Winskell, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913660
- Sponsor's protocol ID
- STUDY00002974
- Other IDs
- 5R33MH124200-04, 2025P009542
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Game to Increase Engagement in Care Among African Adolescents Living With HIV
- ClinicalTrials.gov ID
- NCT06913660
- Acronym / sponsor ID
- STUDY00002974
- Conditions
- Hiv, AIDS, Adolescent Behavior, Treatment Compliance, Treatment Adherence, Reproductive Behavior
- Keywords
- HIV, Smartphone Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 7 Mar 2026 (actual)
- Study completion
- 7 Mar 2026 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized feasibility study, that involves clinic-level randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: MyGoalsThe 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. |
| Control Arm | Active comparator | Behavioral: Standard of careControl-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). |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyGoalsA 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. | Behavioural | Intervention Arm |
| Standard of careAlso: Standard of care packageA 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. | Behavioural | Control Arm |
Primary outcome
Change in knowledge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in viral load (VL) from baseline
Time frame: Baseline, mid-point (around 4 months post-intervention), and endline (9 months post-intervention)
Change in attendance at scheduled clinic visits
Time frame: Baseline, 9 months post-intervention
Change in Retention in care
Time frame: Baseline, 9 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Winskell, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyGoals in people with Hiv and AIDS, run by Emory University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge (time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.