Back to resultsAssessing the Use of MY-RIDE, a Just-in-time Adaptive Intervention, to Improve HIV Prevention and Substance Use in Youth Experiencing Homelessness
Primary Purpose
HIV Infections
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention-control group
MY-RIDE group
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections
Eligibility 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)
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MY-RIDE group
Attention-control group
Arm Description
Outcomes
Primary Outcome Measures
Change in substance use
Secondary Outcome Measures
Change in condom use
Change in PrEP uptake as assessed by the self reported tool
PrEP uptake is defined as the self initiation of HIV prevention medication
Change in sexually transmitted infections (STIs)
This will be assessed by a blood test to detect biomarkers for HIV and Syphilis, and urine test for Gonorrhea and Chlamydia
Full Information
NCT ID
NCT06074354
First Posted
September 22, 2023
Last Updated
October 6, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT06074354
Brief Title
Assessing the Use of MY-RIDE, a Just-in-time Adaptive Intervention, to Improve HIV Prevention and Substance Use in Youth Experiencing Homelessness
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MY-RIDE group
Arm Type
Experimental
Arm Title
Attention-control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Attention-control group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MY-RIDE group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in substance use
Time Frame
baseline, 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Change in condom use
Time Frame
baseline, 3, 6, and 12 months
Title
Change in PrEP uptake as assessed by the self reported tool
Description
PrEP uptake is defined as the self initiation of HIV prevention medication
Time Frame
baseline, 3, 6, and 12 months
Title
Change in sexually transmitted infections (STIs)
Description
This will be assessed by a blood test to detect biomarkers for HIV and Syphilis, and urine test for Gonorrhea and Chlamydia
Time Frame
baseline, 3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM,
Phone
713-500-2002
Email
Diane.M.SantaMaria@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Jones
Phone
713-500-9928
Email
Jennifer.D.Torres@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM,
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM,
Phone
713-500-2002
Email
Diane.M.SantaMaria@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Jones
Phone
713-500-9928
Email
Jennifer.D.Torres@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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