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Positive STEPS for ART Compliance in HIV (STEPS Trial)

N/A

Waitlist Available

Led By Robert Garofalo, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

HIV-infected (perinatally, transfusion, or behaviorally-acquired)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 month, 8 month, 12 month

Awards & highlights

STEPS Trial Summary

This trial is testing whether an intervention to help HIV-infected young adults stick to their ART regimen will work better than the standard of care.

Who is the study for?

This trial is for HIV-infected adolescents and young adults aged 16 to 29 who are on antiretroviral therapy (ART) but have missed doses recently. Participants must speak English, have daily access to a cell phone, live in specified areas, and be willing to attend study visits. Those with severe mental or physical illness or high ART adherence aren't eligible.Check my eligibility

What is being tested?

The 'Positive STEPS' program aims to improve ART adherence using a stepped-care approach. Initially, all participants receive basic intervention; those not improving get more intensive help. The effectiveness of this adaptive method is being tested through random assignment of participants.See study design

What are the potential side effects?

Since the intervention involves behavioral support rather than medication, traditional side effects are not expected. However, participants may experience stress or discomfort discussing their health behaviors.

STEPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on antiretroviral therapy and either started it recently or have missed doses.

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I am HIV-positive.

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I missed more than 3 doses of my ART medication in the last month.

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I am between 16 and 29 years old.

STEPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 month, 8 month, 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 month, 8 month, 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 month, 8 month, 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ART Medication Level in Hair Sample

Daily ART Adherence

Daily ART adherence

+1 more

Secondary outcome measures

Engagement in HIV Care

Medication changes to ART

Reduced HIV Symptoms

STEPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Positive STEPSExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positive STEPS

2011

N/A

~70

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,010 Total Patients Enrolled

Brown UniversityOTHER

456 Previous Clinical Trials

558,162 Total Patients Enrolled

Robert Garofalo, MDPrincipal InvestigatorLurie Children's Hospital

2 Previous Clinical Trials

858 Total Patients Enrolled

Media Library

Positive STEPS Clinical Trial Eligibility Overview. Trial Name: NCT03092531 — N/A

Compliance Research Study Groups: Standard of Care, Positive STEPS

Compliance Clinical Trial 2023: Positive STEPS Highlights & Side Effects. Trial Name: NCT03092531 — N/A

Positive STEPS 2023 Treatment Timeline for Medical Study. Trial Name: NCT03092531 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 30 and over admissible to this experiment?

"This medical study is only open to those between 16 and 29 years old. Although, there are 2 separate trials for minors below 18 and 3 more available to people over 65."

Answered by AI

Would I be a suitable candidate for this clinical research?

"This medical research requires participants to meet certain criteria; specifically, they must be aged between 16 and 29 with a history of adherence. The team plans on recruiting 192 patients in total."

Answered by AI

Where can Canadian patients access this research trial?

"At present, 4 medical centres are recruiting for this clinical trial. These facilities are located in Chicago, Boston, Providence and other nearby areas. To minimise travel requirements when taking part of the study please opt to attend the nearest clinic if possible."

Answered by AI

Is this scientific endeavor still recruiting participants?

"The clinicaltrials.gov listing indicates that this study is not currently enrolling patients, with the initial posting on February 1st 2018 and last update taking place on November 3rd 2022. Nonetheless, there are five other trials actively seeking participants at present."

Answered by AI

Recent research and studies

BMC Public HealthJournal

Positive STEPS – a Randomized Controlled Efficacy Trial of an Adaptive Intervention for Strengthening Adherence to Antiretroviral HIV Treatment Among Youth: Study Protocol

Mimiaga, Matthew J., Lisa M. Kuhns, Katie B. Biello, Jennifer Olson, Sam Hoehnle, Christopher M. Santostefano, Jaclyn M. W. Hughto, et al.. 2018. “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. Springer Science and Business Media LLC. doi:10.1186/s12889-018-5815-9.

Telemedicine and e-HealthJournal

Transitioning from Face to Face to the Digital Space: Best Practices and Lessons Learned Leveraging Technology to Conduct Hiv-focused Interventions

Klasko-Foster, Lynne B., Katie B. Biello, William Lodge II, Jennifer Olson, and Matthew J. Mimiaga. 2022. “Transitioning from Face to Face to the Digital Space: Best Practices and Lessons Learned Leveraging Technology to Conduct Hiv-focused Interventions”. Telemedicine and E-health. Mary Ann Liebert Inc. doi:10.1089/tmj.2021.0190.

Telemedicine and e-HealthJournal

Transitioning from Face to Face to the Digital Space: Best Practices and Lessons Learned Leveraging Technology to Conduct Hiv-focused Interventions

clinicaltrials.govStudy

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