NCT06074354

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
15mo left

Started Nov 2024

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Nov 2024Aug 2027

First Submitted

Initial submission to the registry

September 22, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 11, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

September 22, 2023

Last Update Submit

May 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in substance use

    baseline, end of intervention (3 months after baseline), 3 months after intervention, 6 months after intervention, and 12 months after intervention

Secondary Outcomes (3)

  • Change in condom use

    baseline, end of intervention (3 months after baseline), 3 months after intervention, 6 months after intervention, and 12 months after intervention

  • Change in PrEP uptake as assessed by the self reported tool

    baseline, end of intervention (3 months after baseline), 3 months after intervention, 6 months after intervention, and 12 months after intervention

  • Change in sexually transmitted infections (STIs)

    baseline, end of intervention (3 months after baseline), 3 months after intervention, 6 months after intervention, and 12 months after intervention

Study Arms (2)

MY-RIDE group

EXPERIMENTAL
Behavioral: MY-RIDE group

Attention-control group

ACTIVE COMPARATOR
Behavioral: Attention-control group

Interventions

MY-RIDE groupBEHAVIORAL

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.

MY-RIDE 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.

Attention-control group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 15-month study period.

You may not qualify if:

  • Youth Experiencing Homelessness (YEH) who have low literacy based on the Rapid Estimate of Adult Literacy in Medicine-Short Form (scores \< 4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • Santa Maria D, Padhye N, Businelle M, Slesnick N, Ricondo S, Lightfoot M. Just-in-Time Adaptive Intervention to Improve HIV Prevention and Substance Use in Youth Experiencing Homelessness (MY-RIDE): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 10;14:e78006. doi: 10.2196/78006.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 10, 2023

Study Start

November 11, 2024

Primary Completion (Estimated)

August 23, 2027

Study Completion (Estimated)

August 23, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations