HIV
Conditions
Keywords
HIV, Telemedicine
Brief summary
The purpose of this research study is to see how effective the addition of video to home telehealth services is in helping patients with HIV to remain in care, which is vital to management of their illness. The investigators also want to understand how to best put the video to home services into practice.
Interventions
OTHERVVC
Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Veterans in the Infections Disease clinic at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) will be randomly assigned to either an offer of VA Video Connect (VVC) delivered HIV care or to usual care for HIV. All treatment as usual options for HIV care will be available to all patients in both treatment arms, however only the Veterans in the VVC arm will be actively offered this VA-approved technology.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient in the Infectious Diseases clinic at Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX, with HIV infection * At least 18 years of age * Able to speak English * Able to consent to the use of VVC
Exclusion criteria
* Unable to use or consent to use VVC, due to either significant physical or mental disability * Incarcerated (though MEDVAMC does not generally provide care for prisoners)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constancy Retention in Care Measure | From enrollment to the end of follow-up at 12 months | Completion of at least 1 visit with a primary care or Infectious Disease provider in each 6 months of the year at least 60 days apart. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Retention in Care Measure | 12 months | Percentage of scheduled HIV clinic appointments attended over 12 months |
| Completed Visits for Adherence Counseling | 12 months | Number of completed visits for counseling, mental health, and social services during the year. |
| HIV Suppression | 12 months | Number of Veterans with HIV on ART whose most recent viral load during the 12-month period was \<200c/mL |
| Percent ART Medication Dispensed (as a Proxy for Medication Adherence) | 12 months | The percentage of ART medication dispensed was calculated by dividing the total number of ART medication pills dispensed during each 365-day observation period (i.e., baseline and 12-month follow-up) by 365 and then multiplying by 100, yielding a percentage (0-100%). This pharmacy dispensing measure serves as a proxy for medication adherence, with higher percentages indicating greater medication availability. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJan Alexandra Lindsay, PhD
Michael E. DeBakey VA Medical Center, Houston, TX
Participant flow
Recruitment details
Participants were enrolled at completion of a scheduled medical visit. The first participant was enrolled on July 1, 2021 and the last participant was enrolled on May 24, 2022.
Pre-assignment details
Of 472 randomized scheduled clinic appointments, 306 appointments were completed and enrolled in the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Adherence Retention in Care | 78.56 Percent visits attended STANDARD_DEVIATION 21.61 |
| Age, Continuous | 57.36 years STANDARD_DEVIATION 12.59 |
| Alcohol Use Disorders Identification Test (AUDIT-C ) Low-risk (0-4) | 222 Participants |
| Alcohol Use Disorders Identification Test (AUDIT-C ) Positive/Moderate or higher risk (>=5) | 20 Participants |
| Alcohol Use Disorders Identification Test (AUDIT-C ) | 1.61 Score on screening tool STANDARD_DEVIATION 2.26 |
| Antiretroviral Therapy (ART) Medication adherence | 91.06 Percent adherence STANDARD_DEVIATION 12.9 |
| CD4 Cell count <200 | 3 Participants |
| CD4 Cell count 200-499 | 9 Participants |
| CD4 Cell count >=500 | 34 Participants |
| Completed visits for adherence counseling | 3.88 Number of visits STANDARD_DEVIATION 2 |
| Constancy Retention in Care | 241 Participants |
| Drive time to MEDVAMC | 37.46 minutes STANDARD_DEVIATION 30.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 272 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| HIV Viral Load >=200 | 16 Participants |
| HIV Viral Load <200 (suppressed) | 136 Participants |
| OEF/OIF Status Not OEF/OIF | 173 Participants |
| OEF/OIF Status OEF/OIF | 67 Participants |
| Patient Health Questionnaire-2 (PHQ-2) Score 0-2 | 85 Participants |
| Patient Health Questionnaire-2 (PHQ-2) Score 3-6 (likely MDD) | 16 Participants |
| Patient Health Questionnaire-2 (PHQ-2) | 0.56 Scale score STANDARD_DEVIATION 1.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 194 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 103 Participants |
| Region of Enrollment United States | 154 Participants |
| Rural zip code Not rural | 139 Participants |
| Rural zip code Rural | 14 Participants |
| Sex/Gender, Customized Female | 4 Participants |
| Sex/Gender, Customized Male | 150 Participants |
| Sex/Gender, Customized Transgender | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 154 | 4 / 152 |
| other Total, other adverse events | 62 / 154 | 61 / 152 |
| serious Total, serious adverse events | 42 / 154 | 38 / 152 |
Outcome results
None listed