Clinical trial NCT03092531: Positive Steps to Enhance Problem Solving Skills
Official title: Adaptive Intervention Strategies Trial for Strengthening Adherence to Antiretroviral HIV Treatment Among Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence
Keywords: HIV
ART Adherence
Adolescents
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2017-03-28
Enrollment: 123
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduced HIV Viral Load
timeFrame: Baseline, 4 month, 8 month, 12 month
measure: ART Medication Level in Hair Sample
timeFrame: Baseline, 4 month, 8 month, 12 month
measure: Daily ART adherence
timeFrame: 4 month, 8 month, 12 month
measure: Daily ART Adherence
timeFrame: Baseline, 4 month, 8 month, 12 month
Secondary outcomes:
measure: Reduced HIV Symptoms
timeFrame: Baseline, 4 month, 8 month, 12 month
measure: Engagement in HIV Care
timeFrame: Baseline, 4 month, 8 month, 12 month
measure: Medication changes to ART
timeFrame: Baseline, 4 month, 8 month, 12 month
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for LGBTQ+ Advocacy, Research & Health
state: California
city: Chicago
country: United States
facility: Lurie Childrens Hospital
state: Illinois
city: Boston
country: United States
facility: Fenway Health Institute
state: Massachusetts
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: UCLA, School of Public Health, Department of Epidemiology, Fielding School of Public Health
name: Matthew J Mimiaga, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Lurie Children's Hospital
name: Robert Garofalo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klasko-Foster LB, Biello KB, Lodge W 2nd, Olson J, Mimiaga MJ. Transitioning from Face to Face to the Digital Space: Best Practices and Lessons Learned Leveraging Technology to Conduct HIV-Focused Interventions. Telemed J E Health. 2022 Jul;28(7):1070-1073. doi: 10.1089/tmj.2021.0190. Epub 2022 Jan 6.
citation: Mimiaga MJ, Kuhns LM, Biello KB, Olson J, Hoehnle S, Santostefano CM, Hughto JMW, Safi H, Salhaney P, Chen D, Garofalo R. Positive STEPS - a randomized controlled efficacy trial of an adaptive intervention for strengthening adherence to antiretroviral HIV treatment among youth: study protocol. BMC Public Health. 2018 Jul 13;18(1):867. doi: 10.1186/s12889-018-5815-9.