Adherence
Conditions
Keywords
HIV, ART Adherence, Adolescents
Brief summary
This randomized control trial is to test the efficacy of a stepped-care adaptive Antiretroviral Therapy (ART) adherence intervention (Positive STEPS) for HIV infected adolescents and young adults, ages 16 to 29. Stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who do not improve then receive the high intensity, more resource intensive part of an intervention.
Detailed description
HIV infected adolescents and young adults will be recruited from Providence, Rhode Island, Boston, Massachusetts and Chicago, Illinois. Participants will be equally randomized to: 1. Positive STEPS - a stepped care, adherence intervention with integrated technology (2-way daily text messaging aimed at improving ART adherence). If text messaging is not sufficient to overcome the barriers to ART adherence;these individuals will then also receive the more intensive component based on general principles of cognitive-behavioral therapy. 2. Standard of Care comparison group including a brief adherence educational session. This will consist of a review of medications and recommended dosing (i.e., to understand regimen), adherence expectations, toxicity expectations and medication misperceptions.The participant will then view a 20-minute animated tutorial which explains the importance of adherence to antiretroviral medication effectiveness.
Interventions
BEHAVIORALPositive STEPS
Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.
Sponsors
Brown University
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Block randomization
Eligibility
Sex/Gender
ALL
Age
16 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 16 and 29 years of age * HIV-infected (perinatally, transfusion, or behaviorally-acquired) * Currently taking or prescribed antiretroviral therapy and: 1) Began taking ART \< 3 months ago, OR 2) Has been taking ART for \>3 AND has missed one or more doses in the past week or more than 3 doses in the past month. * Daily access to a cell phone * Has lived in the greater Providence, Boston, or Chicago area greater than three months * Self-reports \< 90% ART medication adherence in the past month (i.e., missed one or more doses in the past week or more than 3 doses in the past month) at screening * Able to speak and understand English * Not currently enrolled in another ART-adherence intervention study * Willing and able to complete all study visits in person or remotely via video conferencing platform
Exclusion criteria
* Unable to give informed consent due to severe mental or physical illness, cognitive limitation, or substance intoxication at baseline visit * HIV-uninfected * Not currently on antiretroviral therapy * Does not own a cell phone * Has lived in the greater Providence, Boston, or Chicago area for less than three months or is planning to move outside the area within the next year * Self-reports \> 90% ART medication adherence in the past month AND has been taking ART for more than 3 months * Unable to speak and understand English * Currently enrolled in another ART-adherence intervention study * Not willing to and able to complete all study visits in person or remotely via video conferencing platform
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced HIV Viral Load | Baseline, 4 month, 8 month, 12 month | Blood specimen collection tested for HIV Viral Load |
| ART Medication Level in Hair Sample | Baseline, 4 month, 8 month, 12 month | Collection of hair sample to measure level of ART |
| Daily ART adherence | 4 month, 8 month, 12 month | Monitoring of Wisepill device for electronic adherence data |
| Daily ART Adherence | Baseline, 4 month, 8 month, 12 month | Self report via research assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in HIV Care | Baseline, 4 month, 8 month, 12 month | Number of kept versus number of scheduled visits verified by medical record |
| Medication changes to ART | Baseline, 4 month, 8 month, 12 month | Verified by medical record |
| Reduced HIV Symptoms | Baseline, 4 month, 8 month, 12 month | Medical record review for increase or decrease in symptoms associated with HIV |
Countries
United States
Outcome results
None listed