Positive Steps to Enhance Problem Solving Skills (STEPS)

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Adherence

Treatments: Behavioral: Positive STEPS

Study type: Interventional

Funder types: Other

Identifiers

NCT03092531

1R01NR017098-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 16 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

123 participants in 2 patient groups

Positive STEPS

Experimental group

Description:

Step 1) all participants randomized to the experimental condition will receive low-intensity, daily two-way SMS texts of personalized reminders to take medications as prescribed ("social-cognitive cues"). If a participants demonstrates \>90% adherence they will remain on step one. Participants who continue to have difficulty adhering to their HIV medications at one month after baseline or anytime up to the end of month three (weeks five through twelve) will progress to Step 2) Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.

Treatment:

Behavioral: Positive STEPS

Standard of Care

No Intervention group

Description:

The standard health services offered at each site (e.g., mental health services, case management) and 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.