A Text-Based Adherence Game for Young People Living With HIV in Ghana (TAG)

This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Medication Adherence
• Intervention / Treatment: Behavioral: Text-Based Adherence Game; Behavioral: Standard of Care (SOC)

Detailed Description

Maintaining lifelong adherence to HIV care is a major challenge for older adolescents and young adults (young people) living with HIV in sub-Saharan Africa where HIV infection is globally most prevalent. Innovative, low cost, and easily scaled strategies are urgently needed to improve young people's engagement to HIV treatment and reduce the public health consequences associated with nonadherence including secondary transmission of HIV infection. Modern mobile health (mHealth) interventions improve adherence to care among young people but are currently not feasible for many low-resource areas of sub-Saharan Africa. This includes theory-driven applications that use gamification, where real-life adherence behaviors are combined with interesting story-lines in a mobile game to promote HIV treatment engagement. Whereas web and smartphone access can be limited, traditional cellphones and text messaging are near universal and have been used previously to promote adherence through simple reminders and linkage to staff support in sub-Saharan Africa. However, to date, no text message adherence intervention has been enhanced through the use of gamification. To increase access to this potentially powerful intervention approach, the current study will test a novel mHealth intervention that uses text messages to gamify adherence behavior among YPLH in Ghana. Piloting this intervention will provide information on its feasibility and signs of preliminary efficacy. The ultimate goal following is further evaluation and refinement will be to disseminate the intervention on a large scale across Ghana and other areas of sub-Saharan Africa.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Kumasi, Ghana
    • Komfo Anokye Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Living with HIV
• Reads English and speaks English or a local language (e.g., Twi)
• On antiretroviral therapy
• Access to mobile phone throughout study period
• Able to give consent and not impaired by cognitive or medical limitations as per clinical assessment
• Not involved with another HIV prevention or adherence study
• Evidence of a detectable viral load

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text-Based Adherence Game; Participants in the experimental condition will receive the Text Based Adherence Game. They will receive semi-automated text messages sent by study staff throughout the trial period.	Behavioral: Text-Based Adherence Game; A mobile health intervention facilitated by a cloud-hosted web application and designed to promote adherence to HIV care through text message-delivered gamification strategies including peer comparison, point reinforcement, feedback on adherence outcomes, facilitation of social support, and use of an engaging and culturally-relevant story-line.; Behavioral: Standard of Care (SOC); A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
Active Comparator: Standard of Care (SOC); SOC participants will receive the Standard of Care Intervention which includes receiving a brief adherence counseling session and access to clinic resources, including counseling services, throughout the trial period.	Behavioral: Standard of Care (SOC); A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV-1 viral load	HIV-1 viral load	Past 90 days
Self-reported Medication Adherence	The 3-item Self-Report Medication Adherence Scale is used to measure self-reported antiretroviral adherence in the past 30 days. Responses to each of the three items are linearly transformed to a 0-100 scale with zero being the worst adherence and 100 the best. A total score is calculated as the mean of the three individual item scores and ranges from 0 to 100.	Past 30 days

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Nicholas Tarantino, PhD, Rhode Island Hospital

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: adolescent; adherence; young adult; Africa; mhealth; viral load
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 1227391; K23MH114632 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No