Piloting the Incentivized Text-Based Adherence Game Intervention.

NCT ID: NCT07115498

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2026-05-30

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

Conditions

HIV Treatment Adherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

iTAG

Participants in this arm receive the iTAG intervention.

Group Type: EXPERIMENTAL

iTAG

Intervention Type: BEHAVIORAL

Participants in this intervention start by receiving a brief (15 minute) in-person standard-of-care counseling session focused on increasing their knowledge of HIV treatment adherence and strategies to improve adherence. Following this session, they will then receive daily or less frequent text messages (SMS) over the course of three months. Messages are primary two-way, automated, and have preprogrammed response options. Message content includes HIV medication reminders, motivational messages, information on topics relevant to HIV treatment (e.g., HIV disclosure) in the form of quizzes, opportunities to reach out for support from clinic staff or peer mentors, and game-based messages including story messages, a weekly scoreboard, point system progress, and peer interactions.

Interventions

iTAG

Participants in this intervention start by receiving a brief (15 minute) in-person standard-of-care counseling session focused on increasing their knowledge of HIV treatment adherence and strategies to improve adherence. Following this session, they will then receive daily or less frequent text messages (SMS) over the course of three months. Messages are primary two-way, automated, and have preprogrammed response options. Message content includes HIV medication reminders, motivational messages, information on topics relevant to HIV treatment (e.g., HIV disclosure) in the form of quizzes, opportunities to reach out for support from clinic staff or peer mentors, and game-based messages including story messages, a weekly scoreboard, point system progress, and peer interactions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Komfo Anokye Teaching Hospital

Kumasi, , Ghana

Site Status: RECRUITING

Countries

Ghana

Central Contacts

Nicholas Tarantino, PhD

Role: CONTACT

ntaranti@providence.edu

1-800-721-6444

Facility Contacts

Betty Norman, MBChB

Role: primary

branorman@yahoo.com

+2330207064699

Other Identifiers

IRB-FY24-62

Identifier Type: -

Identifier Source: org_study_id