Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 99
- Locations
- 2
- Primary Endpoint
- HIV viral load
Study Overview
Brief Summary
In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. We will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. The project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Older than 18
- •Evidence of HIV-1 infection, based on patient's medical history or results of laboratory tests
- •Detectable Viral Load, based on patient's medical record
- •Receiving primary medical care at the AIDS Program at SFGH
- •Able and willing to give informed consent to be randomized to study arms
- •Willing to use the patient portal
- •Has a cell phone with ability to receive and send unlimited SMS texts, Patient of the HIV/AIDS Clinic at ward 86, SFGH
Exclusion Criteria
- •Failure to meet inclusion criteria
Outcomes
Primary Outcomes
HIV viral load
Time Frame: 12 month
The primary analyses of the 12-month trial data will compare the two study groups with respect to (i) change from baseline in CD4 T-cell count; and (ii) proportion of patients whose HIV viral load (VL) level is detectable. We will use repeated-measures analysis techniques to estimate longitudinal prevalence at the population level (via generalized estimating equations) and at the individual levels (via generalized linear mixed models)\[25\].
Secondary Outcomes
- Level of antiretroviral medication in hair(12 month)