A Text-Based Adherence Game for Young People Living With HIV in Ghana (TAG)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03928717 |
|
Recruitment Status :
Recruiting
First Posted : April 26, 2019
Last Update Posted : September 22, 2021
|
Sponsor:
Rhode Island Hospital
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Nicholas Tarantino, Rhode Island Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV/AIDS Medication Adherence | Behavioral: Text-Based Adherence Game Behavioral: Standard of Care (SOC) | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | A Text-Based Adherence Game for Young People Living With HIV in Ghana |
| Actual Study Start Date : | August 23, 2021 |
| Estimated Primary Completion Date : | March 2023 |
| Estimated Study Completion Date : | March 2023 |
| 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. |
Primary Outcome Measures :
- HIV-1 viral load [ Time Frame: Past 90 days ]HIV-1 viral load
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 24 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928717
Contacts
| Contact: Nicholas Tarantino, PhD | 401-793-8706 | nicholas_tarantino@brown.edu | |
| Contact: Larry Brown, MD | 401-444-8539 | lkbrown@lifespan.org |
Locations
| Ghana | |
| Komfo Anokye Teaching Hospital | Recruiting |
| Kumasi, Ghana | |
| Contact: Nicholas Tarantino, PhD 4017938706 nicholas_tarantino@brown.edu | |
Sponsors and Collaborators
Rhode Island Hospital
National Institute of Mental Health (NIMH)
Investigators
| Principal Investigator: | Nicholas Tarantino, PhD | Rhode Island Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nicholas Tarantino, Sr. Research Scientist, Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT03928717 |
| Other Study ID Numbers: |
1227391 K23MH114632 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 26, 2019 Key Record Dates |
| Last Update Posted: | September 22, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Nicholas Tarantino, Rhode Island Hospital:
|
adherence young adult Africa |
mhealth adolescent viral load |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome 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 Immunologic Deficiency Syndromes Immune System Diseases |