MY-RIDE Program for HIV Prevention

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

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Low literacy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the MY-RIDE program (Motivating Youth to Reduce Infections, Disconnections, and Emotion dysregulation) can reduce substance use and enhance HIV prevention efforts. The researchers aim to determine if the program increases willingness to take PrEP (a medication that helps prevent HIV), manage stress, and utilize mental health and substance use services. Participants will either follow the MY-RIDE program or join a comparison group. Suitable candidates for this trial are English-speaking individuals experiencing homelessness who have used substances, recently engaged in sexual activity, and plan to remain in the metro area for the next 15 months. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future HIV prevention strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that the MY-RIDE program is safe for youth?

Research has shown that the MY-RIDE program helps young people manage their emotions to reduce risky behaviors. The program includes short messages aimed at improving HIV prevention and reducing substance use among youth. While specific information on side effects or negative reactions related to MY-RIDE is not available, the program is non-invasive. This means it does not involve taking medicine or undergoing medical procedures, which typically lowers the chance of physical side effects. The trial is in a phase called "Not Applicable," focusing on changing behaviors rather than testing a new drug, which generally presents fewer safety risks. Participants in similar studies have usually responded well to this type of program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MY-RIDE Program for HIV prevention because it offers a novel approach compared to traditional methods like PrEP medications. Unlike the standard of care, which typically involves daily pill regimens, MY-RIDE focuses on behavioral intervention through personalized, interactive sessions designed to empower individuals and promote safer practices. This program could enhance engagement and adherence, potentially leading to more effective prevention strategies.

What evidence suggests that the MY-RIDE program is effective for HIV prevention?

Research has shown that the MY-RIDE program, which participants in this trial may receive, helps young people manage their emotions to reduce risky behaviors. It aims to lower substance use and promote HIV prevention strategies. Studies suggest that MY-RIDE may also increase the willingness to use PrEP, a medication that helps prevent HIV. Early results have been promising in improving mental health and reducing the urge to use substances. Overall, MY-RIDE is designed to help youth make safer health choices by teaching them to better control their emotions. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for English-speaking youth experiencing homelessness in the metro area, who have used substances and been sexually active recently or plan to be. They should not be planning to move during the study year and must be able to read well enough (RELM-SF score ≥ 4).

Inclusion Criteria

I have been sexually active in the past 6 months or plan to be soon.

Are not planning to move out of the metro area during the 12-month study period

Are experiencing homelessness

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MY-RIDE intervention to improve HIV prevention and reduce substance use

12 months

Regular check-ins at baseline, 3, 6, and 12 months

Follow-up

Participants are monitored for changes in STIs and PrEP uptake

12 months

Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention-control group
• MY-RIDE

Trial Overview The MY-RIDE program aims to reduce substance use and increase HIV prevention strategies among homeless youth. It will be compared with an attention-control group, focusing on willingness to take PrEP, stress levels, urges for substance use, and mental health service usage.

How Is the Trial Designed?

Group I: MY-RIDE group Experimental Treatment 1 Intervention

Group II: Attention-control group Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The study involving 386 trauma-exposed individuals found that difficulties in regulating positive emotions are linked to increased risky sexual behaviors (RSB), highlighting the importance of emotional regulation in sexual health.

Specifically, nonacceptance of positive emotions was associated with impulsive sexual behaviors, while difficulties controlling impulses were linked to risky anal sex acts, suggesting that addressing these emotional regulation issues could be beneficial in reducing RSB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Difficulties Regulating Positive Emotions Contribute to Risky Sexual Behavior? A Path Analysis. Weiss, NH., Forkus, SR., Contractor, AA., et al.[2020]

In a study of 174 men who have sex with men (MSM), anxiety was found to increase risky sexual behavior and substance use, particularly when their decision-making abilities were intact, highlighting the need to address anxiety in HIV prevention strategies.

HIV-positive participants reported fewer days of substance use compared to HIV-negative participants, suggesting that HIV status may influence substance use behavior, but the relationship between emotional distress and risk-taking was consistent across both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affective differences in Iowa Gambling Task performance associated with sexual risk taking and substance use among HIV-positive and HIV-negative men who have sex with men. Golub, SA., Thompson, LI., Kowalczyk, WJ.[2018]

The IRISS intervention, a positive affect skills program, showed modest improvements in psychological health for individuals newly diagnosed with HIV, particularly in reducing antidepressant use and intrusive thoughts over 15 months.

While the primary outcome of immediate positive affect did not show significant change, the intervention led to higher levels of positive emotions at multiple follow-up points, suggesting lasting benefits over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV. Moskowitz, JT., Carrico, AW., Duncan, LG., et al.[2020]

Project GOLD is a pilot randomized controlled trial involving 108 Black youth aged 14 to 17, aimed at addressing the impact of mental illness and emotion regulation on HIV/STI risk behaviors.

The study found high rates of mental health issues, such as Major Depressive Disorder and substance abuse, alongside risky sexual behaviors, highlighting the urgent need for targeted interventions to reduce HIV/STI infections in this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project GOLD: A pilot randomized controlled trial of a novel psychoeducational HIV/STI prevention intervention for heterosexually-active black youth. Brawner, BM., Jemmott, LS., Wingood, G., et al.[2023]

Project GOLD, a pilot study involving 108 Black youth aged 14-17, aimed to address mental health and emotion regulation in HIV/STI prevention, showing promising effects like fewer sexual partners and lower depressive symptoms at follow-ups.

While the study did not find statistically significant behavior changes overall, participants in the HIV condition demonstrated practically significant improvements in condom negotiation beliefs and mental health outcomes, suggesting the intervention's potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from Project GOLD: A pilot randomized controlled trial of a psychoeducational HIV/STI prevention intervention for black youth. Brawner, BM., Jemmott, LS., Hanlon, AL., et al.[2022]

A Phase II randomized controlled trial involving 110 sexual minority men living with HIV showed that a positive affect intervention combined with community-based contingency management significantly reduced HIV viral load over 15 months compared to a control group.

Participants receiving the positive affect intervention not only had lower viral loads but also reported increased positive feelings and reduced stimulant use, highlighting the intervention's potential to improve both mental health and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine. Carrico, AW., Neilands, TB., Dilworth, SE., et al.[2023]

A study involving 377 adolescents aged 13-19 in therapeutic schools found that those who received an affect management (AM) intervention reported higher condom use at last sex (89%) compared to those who received a general health promotion (HP) intervention (67%), indicating improved sexual risk management.

The AM intervention also significantly increased HIV knowledge among participants, suggesting that incorporating emotional management techniques into HIV prevention programs can enhance their effectiveness for at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affect management for HIV prevention with adolescents in therapeutic schools: the immediate impact of project balance. Brown, LK., Houck, C., Donenberg, G., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41072013/

Just-in-Time Adaptive Intervention to Improve HIV ... Conclusions: The results of this study will determine whether MY-RIDE increases HIV prevention strategies and decreases substance use when ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12552824/

Just-in-Time Adaptive Intervention to Improve HIV ... The results of this study will determine whether MY-RIDE increases HIV prevention strategies and decreases substance use when compared to homeless youth in the ...

3. withpower.com withpower.com/trial/phase-substance-related-disorders-2024-09aa1

MY-RIDE Program for HIV Prevention The MY-RIDE treatment is unique because it focuses on helping young people manage their emotions, especially positive emotions, to reduce risky sexual behaviors ...

4. researchgate.net researchgate.net/publication/396429500_Just-in-Time_Adaptive_Intervention_to_Improve_HIV_Prevention_and_Substance_Use_in_Youth_Experiencing_Homelessness_MY-RIDE_Protocol_for_a_Randomized_Controlled_Trial_Preprint

Just-in-Time Adaptive Intervention to Improve HIV ... CONCLUSIONS The results of this study will determine whether MY-RIDE increases HIV prevention strategies and decreases substance use when ...

5. uth.trialstoday.org uth.trialstoday.org/?page=eJyLViooSi3LzC8tVtJR8nMOMTC2NDQwMrRQ0tG1hAEdYz1DQwsDcxMdQ3NjUzMLSzMDENBRyksuMTA1NjIzMTVUigUAwfMRmw--

UTHealth | Clinical Trials The purpose of this study is to determine whether Motivating Youth to Reduce Infections ... (HIV) prevention strategies and to evaluate MY-RIDE effects on ...

6. researchgate.net researchgate.net/publication/396406247_Just-in-Time_Adaptive_Intervention_to_Improve_HIV_Prevention_and_Substance_Use_in_Youth_Experiencing_Homelessness_MY-RIDE_Protocol_for_a_Randomized_Controlled_Trial

Just-in-Time Adaptive Intervention to Improve HIV ... The intervention (called MY-RID [Motivating Youth to Reduce Infection and Disconnection]) consisted of brief messages delivered via ...

7. uth.trialstoday.org uth.trialstoday.org/?page=eJyLViooSi3LzC8tVtJR8nMOMTCxMDMzMDBR0tG1hAEdYz1DQwsDcxMdQ3NjUzMLS6ACINBRyksuMTA1NjIzMTVUigUAwuERnw--

UTHealth | Clinical Trials The purpose of this study is to determine whether Motivating Youth to Reduce Infections ... (HIV) prevention strategies and to evaluate MY-RIDE effects on ...