Piloting the Incentivized Text-Based Adherence Game Intervention.

NCT07115498 | Recruiting

• 1 other identifier: IRB-FY24-62
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Treatment Adherence

Outcome Measures

Primary Outcomes (2)

• 3-item measure of antiretroviral therapy (ART) adherence

  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.

  30 days

• HIV viral load

  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.

  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.

Study Arms (1)

iTAG

EXPERIMENTAL

Participants in this arm receive the iTAG intervention.

Behavioral: iTAG

Interventions

iTAG 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.

iTAG

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Providence College: lead

Study Sites (1)

Komfo Anokye Teaching Hospital

Kumasi, Ghana

RECRUITING

Central Study Contacts

Nicholas Tarantino, PhD

CONTACT

1-800-721-6444; ntaranti@providence.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: May 16, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-07

Locations

GH (1)