Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brown University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
HIV infected adolescents and young adults will be recruited from Providence, Rhode Island, Boston, Massachusetts and Chicago, Illinois. Participants will be equally randomized to:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive STEPS | Experimental | 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. |
|
| Standard of Care | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive STEPS | Behavioral | Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduced HIV Viral Load | Blood specimen collection tested for HIV Viral Load | Baseline, 4 month, 8 month, 12 month |
| ART Medication Level in Hair Sample | Collection of hair sample to measure level of ART | Baseline, 4 month, 8 month, 12 month |
| Daily ART adherence | Monitoring of Wisepill device for electronic adherence data | 4 month, 8 month, 12 month |
| Daily ART Adherence | Self report via research assessment | Baseline, 4 month, 8 month, 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced HIV Symptoms | Medical record review for increase or decrease in symptoms associated with HIV | Baseline, 4 month, 8 month, 12 month |
| Engagement in HIV Care | Number of kept versus number of scheduled visits verified by medical record |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew J Mimiaga, ScD, MPH | UCLA, School of Public Health, Department of Epidemiology, Fielding School of Public Health | Principal Investigator |
| Robert Garofalo, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for LGBTQ+ Advocacy, Research & Health | Los Angeles | California | 90095 | United States | ||
| Lurie Childrens Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41740073 | Derived | 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. | |
| 34995162 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 25, 2026 | |
| Reset | Apr 13, 2026 | |
| Release | Jun 2, 2026 | |
| Reset | Jun 25, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2019 | Jul 8, 2019 | ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 25, 2026 | Apr 13, 2026 | |||
| Jun 2, 2026 |
Not provided
Not provided
Not provided
Block randomization
| Baseline, 4 month, 8 month, 12 month |
| Medication changes to ART | Verified by medical record | Baseline, 4 month, 8 month, 12 month |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Fenway Health Institute | Boston | Massachusetts | 02215 | United States |
| Brown University School of Public Health | Providence | Rhode Island | 02912 | United States |
| 30001703 | Derived | 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. |
| Jun 25, 2026 |