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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06074354

Collaborator

National Institute of Nursing Research (NINR) (NIH)

450

Enrollment

Location

Arms

Anticipated Duration (Months)

15.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: Attention-control group Behavioral: MY-RIDE group	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

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.

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

Primary Outcome Measures

Change in substance use [baseline, 3, 6, and 12 months]

Secondary Outcome Measures

Change in condom use [baseline, 3, 6, and 12 months]
Change in PrEP uptake as assessed by the self reported tool [baseline, 3, 6, and 12 months]
PrEP uptake is defined as the self initiation of HIV prevention medication
Change in sexually transmitted infections (STIs) [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

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

Principal Investigator: Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM,, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Oct 10, 2023