Piloting the Incentivized Text-Based Adherence Game Intervention.

Not Applicable

Recruiting

• Conditions: HIV Treatment Adherence

• Registration Number: NCT07115498
• Lead Sponsor: Providence College

Brief Summary

This project will develop and test a novel intervention to improve HIV treatment adherence among young adults with HIV who attend an HIV clinic in Kumasi, Ghana. The intervention is called incentivized Text-Based Adherence Game (iTAG). It is delivered solely via text messages and includes many advanced features including a point system that rewards participants for responding to texts, a scoreboard that compares participants' progress with each other, and messages on a range of health and HIV-related topics. To evaluate iTAG, we will recruit 20 young people, ages 18-24, with HIV (YPWH) to complete 90 days worth of intervention text messages. Before and after receiving iTAG messages, they will complete computer assessments used to measure HIV medication adherence as well as other factors believed to be influence adherence such as social support. By examining participants score from before and after receiving the intervention, and by talking with participants after they receive the intervention, we hope to understand whether iTAG is acceptable to YPWH and could potential lead to improvements in their HIV treatment adherence.

Detailed Description

The current study has three aims revolved around developing and testing an intervention, called the incentivized Text-Based Adherence Game (iTAG) which is a text message-delivered intervention to improve HIV treatment adherence among Ghanaian young people with HIV (YPWH(). It expands on a prior intervention, called TAG, which used gamification strategies to improve adherence among YPWH by incorporate economic empowerment strategies including small conditional economic incentives and a peer-led mutual savings account. The central premise guiding this work is that iTAG is a feasible, acceptable, and potentially effective way to further engage YPWH in HIV care. As one of the study aims, we intend to evaluate iTAG with a single-arm pilot trial by examining YPH (N = 20-25) over 12 weeks on outcome trends, i.e., treatment adherence (i.e., antiretroviral use, viral load) and potential mediators (e.g., financial insecurity), acceptability, and indicators of feasibility and implementation potential (e.g., SMS response rate).

The single-arm pilot trial (N = 25 YPWH) will have a 12-week intervention period with pre- and-post-intervention assessments. Survey assessments will occur using an audio-assisted computer self-interview (ACASI) completed in a private space at an HIV clinic in Ghana. A post-intervention interview will also be conducted with 8 participants. Participants will be compensated for each assessment and receive phone credits for iTAG.

Final content, format, and delivery of iTAG will be determined after a prior Development Phase. Initial content, format, and delivery will be based on TAG and are as follows. YPWH receive four types of automated and tailored SMS: adherence messages (i.e., medication and clinic appointment reminders), skill messages on topics related to adherence, and story messages (i.e., SMS related to the game's storyline). Gamification strategies include themed messages, a point/reward system, and a weekly scoreboard message. Messages will also offer linkage to social support and clinic services by triggering email alerts to research staff. In addition, participants will be given opportunities to cash-in game points for mobile money or donate incentives to a mutual savings account. Code words will be used for all HIV-related topics and participants will use pseudonyms to protect privacy.

Survey assessments will be administered by SurveyToGo, an ACASI system, on tablets. The cloud system allows for encrypted storing and transfer of de-identified data collected in Ghana to research staff in the US. Participants will complete the Session Evaluation Form and the Client Satisfaction Questionnaire to assess intervention acceptability. Analytic data will also show text message (SMS) interactions for the purpose of assessing feasibility and engagement. Main outcomes will include (1) self-report of past 30-day ART adherence using a 3-item measure and (2) viral load (log10). Staff will abstract medical chart data and if viral load was not measured in the past 3 months (pre-intervention) or 1 month (post-intervention), it will be assessed at this visit as part of routine care. Secondary outcomes will also be assessed including relevant knowledge (e.g., HIV knowledge), beliefs/attitudes (e.g., attitudes towards ART), and behavior (e.g., treatment self-efficacy), social support, access to services/resources and economic wellbeing (e.g., food insecurity). A 15-min interview will also be conducted with 8 participants to further examine iTAG's acceptability and implementation potential.

Intervention acceptability will be determined using the criteria of mean scores ≥ 24 on the CSQ and ≥30 on the SEF defined as acceptable. An SMS/voice message response/receipt rate of 80% will be deemed as acceptable. To examine outcome trends, we have the following hypothesis: among the YPWH enrolled, at post-intervention, YPWH will demonstrate trends towards an increase in ART adherence and decrease in viral load (log10). They will also show improvements in secondary outcomes. Pre-post intervention differences in these outcomes will be explored using a repeated measures t-test and the Cohen's d effect size

Study Timeline

• Study Start: 2025-05-16
• Status Verified: 2025-07
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2025-11-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Between ages 18-24
• In treatment for HIV at our recruitment site
• Read English and speak English or a language spoken by clinic staff
• On ART medication
• Own a mobile phone
• Evidence of recent ART non-adherence
• Evidence of a detectable viral load in the past 3 months

Exclusion Criteria

• Physically or cognitively impaired
• Participation in another ART adherence intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
3-item measure of antiretroviral therapy (ART) adherence	30 days	This 3-item self-report survey measure assesses recent ART adherence (Wilson et al., 2016).; Wilson, I. B., Lee, Y., Michaud, J., Fowler Jr, F. J., \& Rogers, W. H. (2016). Validation of a new three-item self-report measure for medication adherence. AIDS and Behavior, 20(11), 2700-2708.
HIV viral load	Viral load testing must have been performed in past 3 months for the baseline assessment and in the past month for the 3-month follow-up assessment.	This measure is the biological assessment HIV viral load via blood draw. Consistent with prior studies, viral load will be statistically transformed (log10) to correct for skewness.

Trial Locations

Locations (1)

Komfo Anokye Teaching Hospital; 🇬🇭 Kumasi, Ghana