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

NCT03928717 | Completed Results

• 2 other identifiers: 1227391K23MH114632
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS; Medication Adherence

Keywords

adherence; young adult; Africa; mhealth; adolescent; viral load

Outcome Measures

Primary Outcomes (2)

• HIV-1 Viral Load (log10 Transformed)

  This is a measure of the number of copies of HIV in a person's blood (i.e., copies per ml). It was assessed through blood draw and lab testing. For analyses, raw viral load was log10 transformed to reduce skewness.

  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

Study Arms (2)

Text-Based Adherence Game

EXPERIMENTAL

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; Behavioral: Standard of Care (SOC)

Standard of Care (SOC)

ACTIVE COMPARATOR

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)

Interventions

Text-Based Adherence Game BEHAVIORAL

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.

Text-Based Adherence Game

Standard of Care (SOC) BEHAVIORAL

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.

Standard of Care (SOC); Text-Based Adherence Game

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Komfo Anokye Teaching Hospital

Kumasi, Ghana

Location

Related Publications (2)

• Tarantino N, Norman B, Enimil A, Asibey SO, Martyn-Dickens C, O'Neill K, Guthrie KM, Kwara A, Bock B, Mimiaga MJ, Brown LK. Randomized Pilot Trial of the Text-Based Adherence Game for Ghanaian Youth with HIV. AIDS Behav. 2025 Mar;29(3):791-803. doi: 10.1007/s10461-024-04560-3. Epub 2024 Dec 24.

  PMID: 39719465 DERIVED

• 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.

  PMID: 32779730 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Nick Tarantino
• Organization: Providence College

ntaranti@providence.edu

4018651612

Study Officials

• Nicholas Tarantino, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr. Research Scientist

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 26, 2019
• Study Start: August 23, 2021
• Primary Completion: March 23, 2023
• Study Completion: August 31, 2023
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2024-05

Locations

GH (1)