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Assessing the Use of MY-RIDE, a Just-in-time Adaptive Intervention, to Improve HIV Prevention and Substance Use in Youth Experiencing Homelessness

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ClinicalTrials.gov Identifier: NCT06074354
Recruitment Status : Not yet recruiting
First Posted : October 10, 2023
Last Update Posted : October 10, 2023
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Diane Santa Maria, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
The purpose of this study is to determine whether Motivating Youth to Reduce Infections, Disconnections, and Emotion dysregulation (MY-RIDE) decreases substance use , to determine whether MY-RIDE increases human immunodeficiency virus (HIV) prevention strategies and to evaluate MY-RIDE effects on willingness to take Pre-Exposure Prophylaxis (PrEP), stress, substance use urge, and use of mental health and substance use services when compared to attention control youth

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Attention-control group Behavioral: MY-RIDE group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Assessing the Use of MY-RIDE, a Just-in-time Adaptive Intervention, to Improve HIV Prevention and Substance Use in Youth Experiencing Homelessness
Estimated Study Start Date : January 1, 2024
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: MY-RIDE group Behavioral: MY-RIDE group
MY-RIDE has three main components: 1) One nurse-led face-to-face session; 2) three months of Ecological Momentary Assessments (EMA) with personalized messaging delivered by phone in real-time in response to one's current risk; and 3) access to on-demand healthcare/PrEP navigation and referrals.
Active Comparator: Attention-control group Behavioral: Attention-control group
Participants will receive a one-hour general health promotion session from a nurse and be issued a phone that will deploy the EMA on the same schedule as the intervention arm. They will also receive usual care from the clinics, drop-in center, and shelter recruitment sites. Usual care includes accessing social workers and case managers for immediate housing, food, and clothing needs and assistance in navigating the local Continuum of Care system to access social services.


Outcome Measures
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Primary Outcome Measures :
  1. Change in substance use [ Time Frame: baseline, 3, 6, and 12 months ]

Secondary Outcome Measures :
  1. Change in condom use [ Time Frame: baseline, 3, 6, and 12 months ]
  2. Change in PrEP uptake as assessed by the self reported tool [ Time Frame: baseline, 3, 6, and 12 months ]
    PrEP uptake is defined as the self initiation of HIV prevention medication

  3. Change in sexually transmitted infections (STIs) [ Time Frame: baseline, 3, 6, and 12 months ]
    This will be assessed by a blood test to detect biomarkers for HIV and Syphilis, and urine test for Gonorrhea and Chlamydia


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have engaged in substance use (alcohol or illicit drugs)
  • speak English
  • are experiencing homelessness
  • engaged in sexual activity in the last 6 months or plan to in the next month
  • are not planning to move out of the metro area during the 12-month study period.

Exclusion Criteria:

  • Youth Experiencing Homelessness (YEH) who have low literacy based on the Rapid Estimate of Adult Literacy in Medicine-Short Form (scores < 4)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06074354


Contacts
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Contact: Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM, 713-500-2002 Diane.M.SantaMaria@uth.tmc.edu
Contact: Jennifer Jones 713-500-9928 Jennifer.D.Torres@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM,    713-500-2002    Diane.M.SantaMaria@uth.tmc.edu   
Contact: Jennifer Jones    713-500-9928    Jennifer.D.Torres@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM, The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Diane Santa Maria, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT06074354    
Other Study ID Numbers: HSC-SN-23-0360
First Posted: October 10, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders