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AdherenceSTEPSNCT03092531

Positive Steps to Enhance Problem Solving Skills

A study testing Positive STEPS in people with Adherence, run by University of California, Los Angeles at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Adherence
What is being tested?
Positive STEPS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
4 sitesUnited States
Study dates
1 Feb 2018to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

4 sites in 1 country.

United States4 sites

  • Fenway Health Institute

    Boston, Massachusetts, 02215

  • Lurie Childrens Hospital

    Chicago, Illinois, 60611

  • UCLA Center for LGBTQ+ Advocacy, Research & Health

    Los Angeles, California, 90095

  • Brown University School of Public Health

    Providence, Rhode Island, 02912

Other trials in United States

About this study

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

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.

Read the 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.
Conditions
Adherence
Being tested
Positive STEPS
Keywords
HIV, ART Adherence, Adolescents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive STEPSBehavioural

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

Study groups in NCT03092531
Study groupRoleWhat they receive
Positive STEPSExperimentalStep 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.
Receives: Behavioral: Positive STEPS
Standard of CareNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduced HIV Viral Load

    Blood specimen collection tested for HIV Viral Load

    Measured: Baseline, 4 month, 8 month, 12 month

  2. ART Medication Level in Hair Sample

    Collection of hair sample to measure level of ART

    Measured: Baseline, 4 month, 8 month, 12 month

  3. Daily ART adherence

    Monitoring of Wisepill device for electronic adherence data

    Measured: 4 month, 8 month, 12 month

  4. Daily ART Adherence

    Self report via research assessment

    Measured: Baseline, 4 month, 8 month, 12 month

Secondary outcomes (3)

  1. Reduced HIV Symptoms

    Medical record review for increase or decrease in symptoms associated with HIV

    Measured: Baseline, 4 month, 8 month, 12 month

  2. Engagement in HIV Care

    Number of kept versus number of scheduled visits verified by medical record

    Measured: Baseline, 4 month, 8 month, 12 month

  3. Medication changes to ART

    Verified by medical record

    Measured: Baseline, 4 month, 8 month, 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start1 Feb 2018
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092531
Sponsor's protocol ID
1R01NR017098-01A1
Acronym
STEPS
Status last verified
Jul 2024
First submitted
10 Mar 2017
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Present at least annually on data collected after the second year when sufficient baseline data is collected. Randomized controlled efficacy trial, we anticipate that most of the papers and data-based projects and presentations will happen in year 5, once baseline data and follow-up assessments have occurred. Sharing findings will involve several papers, including a baseline paper, intervention-specific paper, primary paper describing the study outcomes, secondary outcomes papers and potentially a book that describes the intervention, submitting to lead workshops on the intervention approach at relevant national and international meetings and conferences. Raw data for additional analysis will be available by contacting the Principal Investigators.

Publications

  • Yonko EA, Garofalo R, Mimiaga MJ. Moderated Effects of Latinx Ethnicity for a Stepped-Care, Technology and Counseling-Based Intervention (Positive STEPS) on Antiretroviral Adherence and Viral Load Suppression Among Youths With HIV, United States, 2018-2023. Am J Public Health. 2026 Mar;116(S1):S36-S41. doi: 10.2105/AJPH.2025.308341.

    PubMed 41740073

  • 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.

    PubMed 34995162

  • 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.

    PubMed 30001703

Questions about this trial

What is this clinical trial studying?

A study testing Positive STEPS in people with Adherence, run by University of California, Los Angeles at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduced HIV Viral Load (time frame: Baseline, 4 month, 8 month, 12 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092531, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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