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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the MY-RIDE treatment for HIV prevention?

Research suggests that managing emotions can help reduce risky sexual behaviors, which are a major way HIV spreads. Programs that teach young people how to handle their emotions better have shown to increase safe practices like using condoms. ^{1 2 3 4 5}

How is the MY-RIDE treatment for HIV prevention different from other treatments?

The MY-RIDE treatment is unique because it focuses on helping young people manage their emotions, especially positive emotions, to reduce risky sexual behaviors that can lead to HIV. This approach is different from other treatments that may not address the emotional aspects of decision-making in sexual situations. ^{1 2 5 6 7}

Research Team

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

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Do Difficulties Regulating Positive Emotions Contribute to Risky Sexual Behavior? A Path Analysis. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Affect management for HIV prevention with adolescents in therapeutic schools: the immediate impact of project balance. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV. [2020]

4. Switzerland 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. [2023]

5. United States 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. [2023]

6. England 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Results from Project GOLD: A pilot randomized controlled trial of a psychoeducational HIV/STI prevention intervention for black youth. [2022]