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Active, Not Recruiting

NCT Number: NCT06913660

ALHIV Smartphone Game Study

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Adolescent Behavior Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Reproductive Behavior Retroviridae Infections Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence Treatment Adherence and Compliance Treatment Compliance Urogenital Diseases Virus Diseases

Age range

15 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KEMRI Clinical Research Centre

Kisumu, 54840, Kenya

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyGoals

Behavioral

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 Care

Behavioral

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.

Other names: Standard of care package

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Change in viral load (VL) from baseline

    Time frame: 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".

  2. Change in attendance at scheduled clinic visits

    Time frame: Baseline, 9 months post-intervention

    Participant medical records (MR) will be used to review attendance.

  3. Change in Retention in care

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Smartphone Game to Increase Engagement in Care Among African Adolescents Living With HIV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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