HIV InfectionsNCT06074354
Assessing the Use of MY-RIDE, a Just-in-time Adaptive Intervention, to Improve HIV Prevention and Substance Use in Youth Experiencing Homelessness
A study testing MY-RIDE group in people with HIV Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- MY-RIDE group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 23 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Youth Experiencing Homelessness (YEH) who have low literacy based on the Rapid Estimate of Adult Literacy in Medicine-Short Form (scores < 4)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM, 713-500-2002, Diane.M.SantaMaria@uth.tmc.edu
Jennifer Jones, 713-500-9928, Jennifer.D.Torres@uth.tmc.edu
About this study
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
- Conditions
- HIV Infections
- Being tested
- Attention-control group, MY-RIDE group
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention-control groupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MY-RIDE group | Experimental | Not described Receives: Behavioral: MY-RIDE group |
| Attention-control group | Active comparator | Not described Receives: Behavioral: Attention-control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in substance use
Measured: 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
Measured: 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
PrEP uptake is defined as the self initiation of HIV prevention medication
Measured: 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)
This will be assessed by a blood test to detect biomarkers for HIV and Syphilis, and urine test for Gonorrhea and Chlamydia
Measured: baseline, end of intervention (3 months after baseline), 3 months after intervention, 6 months after intervention, and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start11 Nov 2024
- Primary completion23 Aug 2027 (estimated)
- Study completion23 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Diane Santa Maria, The University of Texas Health Science Center, Houston
- Investigators
- Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074354
- Sponsor's protocol ID
- HSC-SN-23-0360
- Other IDs
- 1R01NR020997-01A1
- Status last verified
- May 2026
- First submitted
- 22 Sep 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santa Maria D, Businelle M, Slesnick N, Padhye N, Harrison T, Ging L, Jones JDT, White M. HIV and Substance Use Reduction for Youth Experiencing Homelessness: Development and Usability Study. JMIR Form Res. 2026 May 14;10:e82232. doi: 10.2196/82232.
PubMed 42133932Santa 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.
PubMed 41072013
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06074354
- Acronym / sponsor ID
- HSC-SN-23-0360
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 23 Aug 2027 (estimated)
- Study completion
- 23 Aug 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MY-RIDE group | Experimental | Behavioral: MY-RIDE group |
| Attention-control group | Active comparator | Behavioral: Attention-control group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Youth Experiencing Homelessness (YEH) who have low literacy based on the Rapid Estimate of Adult Literacy in Medicine-Short Form (scores < 4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention-control groupParticipants 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. | Behavioural | Attention-control group |
| MY-RIDE groupMY-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. | Behavioural | MY-RIDE group |
Primary outcome
Change in substance use
Time frame: baseline, end of intervention (3 months after baseline), 3 months after intervention, 6 months after intervention, and 12 months after intervention
3 secondary outcomes
Change in condom use
Time frame: 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
Time frame: 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)
Time frame: baseline, end of intervention (3 months after baseline), 3 months after intervention, 6 months after intervention, and 12 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 42133932Santa Maria D, Businelle M, Slesnick N, Padhye N, Harrison T, Ging L, Jones JDT, White M. HIV and Substance Use Reduction for Youth Experiencing Homelessness: Development and Usability Study. JMIR Form Res. 2026 May 14;10:e82232. doi: 10.2196/82232.
- Derived from this study: PubMed 41072013Santa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM contact
Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MY-RIDE group in people with HIV Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane M Santa Maria, DrPH, MSN, RN, PHNA-BC, FSAHM (713-500-2002, Diane.M.SantaMaria@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in substance use (time frame: baseline, end of intervention (3 months after baseline), 3 months after intervention, 6 months after intervention, and 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074354, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.