ALHIV Smartphone Game Study

Not Applicable

Active, not recruiting

• Conditions: Hiv; Treatment Adherence; AIDS; Adolescent Behavior; Treatment Compliance; Sexual Behavior; Reproductive Behavior

• Registration Number: NCT06913660
• Lead Sponsor: Emory University

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).

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-06
• Study Start: 2025-04-07
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-11
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 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 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 Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (1)

KEMRI Clinical Research Centre; 🇰🇪 Kisumu, Kenya