Positive Steps to Enhance Problem Solving Skills

Adherence Clinical Trial

— STEPS  

Official title:

Adaptive Intervention Strategies Trial for Strengthening Adherence to Antiretroviral HIV Treatment Among Youth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03092531
• Other study ID #: 1R01NR017098-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence

Intervention

Behavioral:
• Positive STEPS
Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.

Locations

Country	Name	City	State
United States	Fenway Health Institute	Boston	Massachusetts
United States	Lurie Childrens Hospital	Chicago	Illinois
United States	UCLA Center for LGBTQ+ Advocacy, Research & Health	Los Angeles	California
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced HIV Viral Load	Blood specimen collection tested for HIV Viral Load	Baseline, 4 month, 8 month, 12 month
Primary	ART Medication Level in Hair Sample	Collection of hair sample to measure level of ART	Baseline, 4 month, 8 month, 12 month
Primary	Daily ART adherence	Monitoring of Wisepill device for electronic adherence data	4 month, 8 month, 12 month
Primary	Daily ART Adherence	Self report via research assessment	Baseline, 4 month, 8 month, 12 month
Secondary	Reduced HIV Symptoms	Medical record review for increase or decrease in symptoms associated with HIV	Baseline, 4 month, 8 month, 12 month
Secondary	Engagement in HIV Care	Number of kept versus number of scheduled visits verified by medical record	Baseline, 4 month, 8 month, 12 month
Secondary	Medication changes to ART	Verified by medical record	Baseline, 4 month, 8 month, 12 month