Human Immunodeficiency Virus
Conditions
Keywords
HIV/AIDS, Adherence, Self-management, Antiretroviral therapy
Brief summary
The overall goal of this project is to use technology to improve adherence to antiretroviral therapy (ART)and increase access to ART adherence care for those HIV+ persons living in rural areas. The LIVE Network audio music program mobile application (app) is innovative, practical, portable, and could be rapidly scaled up to address the adherence self-management needs of rural groups nationwide. If successful, the impact on HIV care will be immense and could transform the delivery of HIV self-management and adherence education by overcoming barriers of geographic isolation, transportation, stigma and confidentiality in this vulnerable group.
Detailed description
The project has two primary aims and one exploratory aim. 1.0 Revise and adapt the Live Network (LN) program and manual for rural persons living with HIV/AIDS (PLWHA) and develop into a mobile application. 2.0 Conduct a randomized controlled trial to test the efficacy of the program. When compared with an educational music control condition at 3, 6, and 9 months post-baseline, those randomized to the LN will have: H1: Significantly higher mean antiretroviral therapy (ART) adherence rates (measured by pill counts, self report). H2: Significantly higher mean levels of ART drug levels in hair sample analyses. H3: Significantly better clinical indicators: higher mean CD4 lymphocyte counts and percents, a larger proportion achieving virologic suppression (proportion with HIV RNA PCR \<50 copies/ml), and smaller proportion with evidence of drug resistance, all as measured by medical record review. 3.0 Explore: a) the effects of LN on symptoms and symptom management; b) the roles of self-efficacy, outcome expectancies, and personal goal setting as mediators, and depression and health literacy as moderators of adherence.
Interventions
BEHAVIORALmobile phone application
Sponsors
National Institute of Nursing Research (NINR)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV+ individuals initiating ART for the first time (except women who may have had ART during pregnancy); or HIV+ individuals changing ART regimen within the past 3 months due to side effects or virologic resistance; or HIV+ individuals with a detectable viral load ≥ 40copies/ml; or HIV+ individuals on ART medication * English speaking * Willing to complete 4 assessments * Willing to complete monthly, unannounced pill counts * Willing to allow collection of hair samples * Willing to be randomly assigned to either condition * Willing to participate in study activities that include using smart phone and mobile app
Exclusion criteria
* Have a history of bilateral hearing loss (health care provider diagnosed or self-identified) * Homeless * Have a cognitive impairment (inability to comprehend the informed consent) * Display psychotic symptoms, as determined by the Brief Symptom Inventory (BSI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Antiretroviral Therapy (ART) Adherence Rates | Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline | Adherence rate was measured with the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days. It includes 5 items scored 1 to 6, with the possible scores for this instrument ranging from 5 to 30, and higher scores reflect better adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses. | 3, 6, and 9 months post-baseline | No data available due to inability of the lab to accurately extract drug from hair. |
| Clinical Indicator: Change in Mean CD4 Percentage | Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention | CD4 count is a test that measures the number of CD4 cells in your blood. CD4 cells, also known as T cell lymphocytes, are white blood cells that fight infection and play an important role in your immune system. A CD4 count is used to check the health of the immune system in people infected with HIV (human immunodeficiency virus). The count measures the number of CD4 cells in a small sample of blood. The percent of CD4 cells measure the percentage of all lymphocytes that are CD4 cells. The study assesses the percentage of CD4 lymphocytes over time. |
| Clinical Indicator: Number of Participants With Non-detectable Viral Load | Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention | Change in number of participants with viral load presented as number of copies if \<50 copies versus ≥ 50 copies. Subjects were coded as having non-detectable viral loads if the load was \< 50 copies. The analyses performed reflects the number of subjects with non-detectable load (\<50) at Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled in the trial starting in June 2014 and randomized either to Educational music mobile app or to the Live Network mobile phone app
Participants by arm
| Arm | Count |
|---|---|
| Educational Music Mobile App A prerecorded program of songs on various topics in a mobile phone application (app). It is designed to provide education about non-health related topics and will be equivalent in length to the intervention app.
mobile phone application | 77 |
| Live Network Mobile Phone App The LN is a prerecorded mobile phone application (app). It employs a radio talk show format in which a Disc Jockey entertains HIV medication-, adherence-, and self-management-related questions and comments from callers and poses them to expert care providers, whose responses to these questions are augmented by songs that shed additional light on these issues.
mobile phone application | 72 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Incarceration | 1 | 1 |
| Overall Study | Lost to Follow-up | 21 | 13 |
| Overall Study | Withdrawal by Subject | 0 | 7 |
Baseline characteristics
| Characteristic | Total | Educational Music Mobile App | Live Network Mobile Phone App |
|---|---|---|---|
| Age, Continuous | 39.4 years STANDARD_DEVIATION 11.6 | 41.4 years STANDARD_DEVIATION 11.6 | 37.3 years STANDARD_DEVIATION 11.1 |
| Consider Yourself to be Bisexual | 17 Participants | 5 Participants | 12 Participants |
| Consider Yourself to be Gay/Homosexual | 55 Participants | 28 Participants | 27 Participants |
| Consider Yourself to be None of the above | 6 Participants | 2 Participants | 4 Participants |
| Consider Yourself to be Straight/Heterosexual | 71 Participants | 42 Participants | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 115 Participants | 61 Participants | 54 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Female | 51 Participants | 28 Participants | 23 Participants |
| Sex: Female, Male Male | 98 Participants | 49 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 1 / 72 |
| other Total, other adverse events | 0 / 77 | 0 / 72 |
| serious Total, serious adverse events | 0 / 77 | 0 / 72 |
Outcome results
Primary
Change in Antiretroviral Therapy (ART) Adherence Rates
Adherence rate was measured with the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days. It includes 5 items scored 1 to 6, with the possible scores for this instrument ranging from 5 to 30, and higher scores reflect better adherence.
Time frame: Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
Population: Population included only subjects that were able to complete the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days. The possible scores for this instrument range from 5 to 30, and higher scores reflect better adherence.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Educational Music Mobile App | Change in Antiretroviral Therapy (ART) Adherence Rates | 6 months | 26.60 score on a scale | Standard Deviation 5.48 |
| Educational Music Mobile App | Change in Antiretroviral Therapy (ART) Adherence Rates | Baseline | 27.04 score on a scale | Standard Deviation 4.23 |
| Educational Music Mobile App | Change in Antiretroviral Therapy (ART) Adherence Rates | 9 months | 26.45 score on a scale | Standard Deviation 5.9 |
| Educational Music Mobile App | Change in Antiretroviral Therapy (ART) Adherence Rates | 3 months | 26.14 score on a scale | Standard Deviation 4.81 |
| Live Network Mobile Phone App | Change in Antiretroviral Therapy (ART) Adherence Rates | 9 months | 26.38 score on a scale | Standard Deviation 5.99 |
| Live Network Mobile Phone App | Change in Antiretroviral Therapy (ART) Adherence Rates | Baseline | 26.25 score on a scale | Standard Deviation 5.18 |
| Live Network Mobile Phone App | Change in Antiretroviral Therapy (ART) Adherence Rates | 6 months | 27.81 score on a scale | Standard Deviation 3.9 |
| Live Network Mobile Phone App | Change in Antiretroviral Therapy (ART) Adherence Rates | 3 months | 26.48 score on a scale | Standard Deviation 5.39 |
Secondary
Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.
No data available due to inability of the lab to accurately extract drug from hair.
Time frame: 3, 6, and 9 months post-baseline
Population: Data were not collected.
Secondary
Clinical Indicator: Change in Mean CD4 Percentage
CD4 count is a test that measures the number of CD4 cells in your blood. CD4 cells, also known as T cell lymphocytes, are white blood cells that fight infection and play an important role in your immune system. A CD4 count is used to check the health of the immune system in people infected with HIV (human immunodeficiency virus). The count measures the number of CD4 cells in a small sample of blood. The percent of CD4 cells measure the percentage of all lymphocytes that are CD4 cells. The study assesses the percentage of CD4 lymphocytes over time.
Time frame: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
Population: Population includes participants with a valid CD4 sample analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Educational Music Mobile App | Clinical Indicator: Change in Mean CD4 Percentage | 3 months post-intervention | 21.68 percentage of CD4 | Standard Deviation 12.37 |
| Educational Music Mobile App | Clinical Indicator: Change in Mean CD4 Percentage | 9 months post-intervention | 26.13 percentage of CD4 | Standard Deviation 11.92 |
| Educational Music Mobile App | Clinical Indicator: Change in Mean CD4 Percentage | 6 months post-intervention | 27.08 percentage of CD4 | Standard Deviation 12.9 |
| Educational Music Mobile App | Clinical Indicator: Change in Mean CD4 Percentage | 9 to 12 months post-intervention | 24.80 percentage of CD4 | Standard Deviation 11.4 |
| Educational Music Mobile App | Clinical Indicator: Change in Mean CD4 Percentage | Baseline | 21.87 percentage of CD4 | Standard Deviation 12.66 |
| Live Network Mobile Phone App | Clinical Indicator: Change in Mean CD4 Percentage | 9 to 12 months post-intervention | 26.39 percentage of CD4 | Standard Deviation 10.49 |
| Live Network Mobile Phone App | Clinical Indicator: Change in Mean CD4 Percentage | Baseline | 26.07 percentage of CD4 | Standard Deviation 14.26 |
| Live Network Mobile Phone App | Clinical Indicator: Change in Mean CD4 Percentage | 3 months post-intervention | 25.91 percentage of CD4 | Standard Deviation 12.32 |
| Live Network Mobile Phone App | Clinical Indicator: Change in Mean CD4 Percentage | 6 months post-intervention | 26.23 percentage of CD4 | Standard Deviation 13.27 |
| Live Network Mobile Phone App | Clinical Indicator: Change in Mean CD4 Percentage | 9 months post-intervention | 24.08 percentage of CD4 | Standard Deviation 14.08 |
Secondary
Clinical Indicator: Number of Participants With Non-detectable Viral Load
Change in number of participants with viral load presented as number of copies if \<50 copies versus ≥ 50 copies. Subjects were coded as having non-detectable viral loads if the load was \< 50 copies. The analyses performed reflects the number of subjects with non-detectable load (\<50) at Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention.
Time frame: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
Population: Only number of participants with available lab tests are included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Educational Music Mobile App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | 3 months post-intervention | 49 Participants |
| Educational Music Mobile App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | 9 months post-intervention | 27 Participants |
| Educational Music Mobile App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | 6 months post-intervention | 40 Participants |
| Educational Music Mobile App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | 9 to 12 months post-intervention | 26 Participants |
| Educational Music Mobile App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | Baseline | 25 Participants |
| Live Network Mobile Phone App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | 9 to 12 months post-intervention | 27 Participants |
| Live Network Mobile Phone App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | Baseline | 21 Participants |
| Live Network Mobile Phone App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | 3 months post-intervention | 35 Participants |
| Live Network Mobile Phone App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | 6 months post-intervention | 38 Participants |
| Live Network Mobile Phone App | Clinical Indicator: Number of Participants With Non-detectable Viral Load | 9 months post-intervention | 33 Participants |