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

Primary Purpose

HIV/AIDS, Medication Adherence

Status
Active
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Text-Based Adherence Game
Standard of Care (SOC)
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring adherence, young adult, Africa, mhealth, adolescent, viral load

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Komfo Anokye Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Text-Based Adherence Game

Standard of Care (SOC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HIV-1 viral load
HIV-1 viral load
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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2019
Last Updated
May 5, 2022
Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03928717
Brief Title
A Text-Based Adherence Game for Young People Living With HIV in Ghana
Acronym
TAG
Official Title
A Text-Based Adherence Game for Young People Living With HIV in Ghana
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Medication Adherence
Keywords
adherence, young adult, Africa, mhealth, adolescent, viral load

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text-Based Adherence Game
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text-Based Adherence Game
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care (SOC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV-1 viral load
Description
HIV-1 viral load
Time Frame
Past 90 days
Title
Self-reported Medication Adherence
Description
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.
Time Frame
Past 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Tarantino, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Komfo Anokye Teaching Hospital
City
Kumasi
Country
Ghana

12. IPD Sharing Statement

Citations:
PubMed Identifier
32779730
Citation
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.
Results Reference
derived

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

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