- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03928717
A Text-Based Adherence Game for Young People Living With HIV in Ghana (TAG)
December 15, 2023 updated by: Nicholas Tarantino, Rhode Island Hospital
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kumasi, Ghana
- Komfo Anokye Teaching Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
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.
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.
|
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
Time Frame: Past 90 days
|
HIV-1 viral load
|
Past 90 days
|
Self-reported Medication Adherence
Time Frame: Past 30 days
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicholas Tarantino, PhD, Rhode Island Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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