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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06074354
Other study ID # HSC-SN-23-0360
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date June 1, 2026

Study information

Verified date May 2024
Source The University of Texas Health Science Center, Houston
Contact Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM,
Phone 713-500-2002
Email Diane.M.SantaMaria@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date June 1, 2026
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in substance use baseline, 3, 6, and 12 months
Secondary Change in condom use baseline, 3, 6, and 12 months
Secondary Change in PrEP uptake as assessed by the self reported tool PrEP uptake is defined as the self initiation of HIV prevention medication baseline, 3, 6, and 12 months
Secondary 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 baseline, 3, 6, and 12 months
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