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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH114632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Tarantino, PhD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Komfo Anokye Teaching Hospital | Kumasi | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39719465 | Derived | 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. | |
| 32779730 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analyses were conducted with participants who had viral load data at all three time points (n = 48). | Posted | Mean | Standard Deviation | log10 HIV copies/mL | Past 90 days |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nick Tarantino | Providence College | 4018651612 | ntaranti@providence.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2021 | Mar 21, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2021 | Mar 21, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| 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. |
|
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Visual Analog Scale Past 28-Day Adherence | The is the Visual Analog Scale which measures past 28-day antiretroviral adherence with a single item. Higher scores equal greater adherence. The scale ranges from 0 to 10. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. 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 | 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. | Analyses were conducted with participants who had completed survey assessments at all three time points (n = 51). | Posted | Mean | Standard Deviation | units on a scale | Past 30 days |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |