ENTRUST Program for Substance Use Disorder and HIV/AIDS

(ENTRUST Trial)

Overseen By Eric Schrimshaw Chair, Department of Population Health Sciences, UCF, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: Minors, Non-English/Spanish speakers, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called ENTRUST, which includes Truvada as a Pre-Exposure Prophylaxis, to assist transgender women in Florida facing challenges related to substance use and HIV. The program provides financial education and personalized counseling to improve access to substance use and HIV care. Participants will join one of two groups: one will start the ENTRUST program immediately, while the other will begin later. Transgender women who are economically vulnerable, at risk for substance use disorders or HIV, and live in South or Central Florida may be well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative solutions tailored to their community's needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the ENTRUST intervention is safe for transgender women?

Research has shown that the ENTRUST program includes strategies like SBIRT counseling, a brief session to address substance use, and economic empowerment activities. Although specific safety data for this program is unavailable, its focus on education and support rather than medication suggests low risks. Participants typically engage in activities like money management, which are generally safe.

The program also endorses HIV prevention methods such as PrEP (pre-exposure prophylaxis). PrEP has been thoroughly researched and proven safe and highly effective in preventing HIV when used as directed. Following the guidance provided during the trial is crucial to ensure safety and maximize benefits.

The trial is in a phase called "Not Applicable," indicating it aims to evaluate the program's real-life application rather than test a new drug. This suggests minimal safety concerns, with the emphasis on understanding the program's impact. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENTRUST program because it combines several innovative approaches to help people with substance use disorder and HIV/AIDS. Unlike standard treatments that might focus solely on counseling or medication, ENTRUST includes economic strengthening and photovoice training alongside an adapted SBIRT-T (Screening, Brief Intervention, and Referral to Treatment). This holistic approach aims to empower individuals by addressing economic challenges and using creative expression as part of the healing process, which could lead to more sustainable recovery outcomes.

What evidence suggests that the ENTRUST intervention could be effective for substance use disorder and HIV/AIDS?

Research has shown that financial stability and education can reduce substance use and improve adherence to HIV treatments. In this trial, the ENTRUST program, provided to participants in the intervention arm, combines money management lessons with counseling to support transgender women in maintaining their substance use and HIV care. Studies indicate that addressing financial challenges and offering personalized support can enhance healthcare involvement. Early results suggest this method could improve health for transgender women, who often encounter healthcare difficulties. Although specific results for ENTRUST are not yet available, similar programs have shown promise in improving healthcare access and outcomes. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult transgender women in South or Central Florida who are economically disadvantaged and at high risk for substance use disorders and HIV. They must be willing to engage in substance use services, HIV care, or PrEP programs, and able to attend study visits either remotely or in person.

Exclusion Criteria

I am a minor transgender woman who does not speak English or Spanish and cannot attend visits in South or Central Florida.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the ENTRUST intervention, including SBIRT-T, economic empowerment, and photovoice training

6 months

4-15 visits (in-person or remote)

Follow-up

Participants are monitored for engagement and retention in substance use and HIV services, as well as other support services

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ENTRUST

Trial Overview The ENTRUST intervention combines financial education with tailored counseling (SBIRT) aimed at helping participants manage substance use and access HIV services. Participants will either receive this new approach immediately or after a waitlist period, during which they can still complete study visits.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

ENTRUST intervention comprised of adapted SBIRT-T, economic strengthening and photovoice training

Group II: Waitlist Control Active Control 1 Intervention

SBIRT-T only

ENTRUST is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Truvada for:

• HIV prevention in adults and adolescents weighing at least 35 kg

Approved in European Union as Truvada for:

• Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk

Approved in Canada as Truvada for:

• Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The 'I Am Men's Health' program successfully improved adherence to PrEP among 23 young men of color at high risk for HIV, achieving an average adherence rate of 73% over a 28-week period.

This innovative approach to promoting PrEP adherence may serve as a model for future large-scale HIV prevention efforts, particularly in communities with high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men. Daughtridge, GW., Conyngham, SC., Ramirez, N., et al.[2022]

The study demonstrated that pre-exposure prophylaxis (PrEP) using Truvada is a highly effective strategy for preventing HIV infection among men who have sex with men, with strong retention and compliance rates observed during the study period from January 2017 to March 2021.

Safety assessments indicated that PrEP was well-tolerated, with no significant adverse events related to Truvada, and regular monitoring of renal function showed no major issues, supporting the safety of this preventive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. Terada-Hirashima, J., Mizushima, D., Takano, M., et al.[2023]

Pre-exposure prophylaxis (PrEP), particularly using Truvada® (tenofovir disoproxil fumarate/emtricitabine), has been shown to effectively reduce the incidence of HIV infection among high-risk individuals, especially when combined with other preventive methods.

While PrEP has a good safety profile, with mild to moderate gastrointestinal side effects being the most common, regular monitoring of liver enzymes, renal function, and bone mineral density is essential to manage potential long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. Tetteh, RA., Yankey, BA., Nartey, ET., et al.[2022]

Truvada is the only drug currently approved for the prevention of HIV infections, marking it as a crucial option in public health efforts against the virus.

As a key component of pre-exposure prophylaxis (PrEP), Truvada is designed to prevent HIV infection before exposure, rather than treating it after infection occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regimen Change: Gilead's TAF Drugs Toppling TDFs in HIV Treatment. Reinke, T.[2021]

A peri-coital regimen of Truvada (FTC and TDF) was shown to fully protect macaques from vaginal SHIV infection after 18 exposures, indicating its efficacy in preventing HIV transmission.

Despite lower concentrations of the drug in vaginal tissues compared to rectal tissues, the treatment was effective, suggesting that simplified PrEP regimens could be developed for women to prevent HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of vaginal SHIV transmission in macaques by a coitally-dependent Truvada regimen. Radzio, J., Aung, W., Holder, A., et al.[2021]

Truvada® (tenofovir plus emtricitabine) is effective in reducing the risk of HIV infection in uninfected individuals who have stable sexual partners with HIV.

There is a growing concern that the use of Truvada® may lead to an increase in sexually transmitted infections among individuals with multiple partners, as they may develop a false sense of security regarding their sexual health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Pre-Exposure Prophylaxis - Is it just about pills? Fernandez-Montero, JV.[2017]

In a study of 132 pregnant individuals with opioid use disorder (OUD), 76.5% were found eligible for preexposure prophylaxis (PrEP) based on modified ACOG criteria, highlighting a significant need for PrEP among this population.

Comorbid psychiatric illness was identified as a significant risk factor for PrEP eligibility, suggesting that mental health support may be crucial in managing pregnant individuals with OUD and assessing their risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Preexposure Prophylaxis Eligibility among Pregnant People with Opioid Use Disorder. Young, AMP., Reddy, P., Gonzalez, AM., et al.[2023]

Tenofovir/emtricitabine (Truvada) has been shown to be highly effective as preexposure prophylaxis (PrEP) for preventing HIV infection, with studies indicating excellent prevention when taken at least four times a week.

Despite its efficacy, challenges remain in the USA regarding awareness and acceptance of PrEP among at-risk individuals and healthcare providers, which are crucial for scaling up its use effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. Elion, R., Coleman, M.[2023]

Citations

1. nida.nih.gov nida.nih.gov/about-nida/organization/offices/hiv-research-program-hrp/avenir-awards-hivaids-research

Avenir Awards for HIV Research - NIDA - NIH ... prevention of HIV/AIDS among substance users. Hear from Avenir ... substance use disorder treatment in the HIV primary care setting.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687690/

Efficacy and Safety of Pre-Exposure Prophylaxis to Control ... The safety of PrEP was evaluated by monitoring serum creatinine levels for symptoms of renal function disorder, which is a known adverse ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02213328

Acceptability, Safety, and Use of Daily Truvada Pre- ... The disease, disorder, syndrome, illness, or injury that is being studied. ... intervention to collect final data for the primary outcome measure. Whether ...

4. gilead.com gilead.com/news/news-details/2018/gilead-announces-new-data-on-the-impact-of-truvada-emtricitabine-and-tenofovir-disoproxil-fumarate-for-pre-exposure-prophylaxis-prep-on-the-number-of-hiv-diagnoses-in-the-united-states

Gilead Announces New Data on the Impact of Truvada® ... Data show that states with highest use of Truvada for PrEP had significant declines in new HIV infections.

5. descovyhcp.com descovyhcp.com/discover-clinical-trial

99.7% remained HIV negative with DESCOVY ®1,2 Proven prevention with powerful results: 99.7% remained HIV negative with DESCOVY · DISCOVER is the largest PrEP clinical trial, with over 5300 participants ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5362649/

Pre-Exposure Prophylaxis for HIV Prevention: Safety ... The TDF2 trial in Botswana gave a reduction rate of 63% against placebo and 77.9% after secondary analysis; therefore, confirming the obvious ...

7. cdc.gov cdc.gov/mmwr/volumes/74/rr/rr7401a1.htm

Antiretroviral Postexposure Prophylaxis After Sexual .. ... When taken as prescribed, PrEP can reduce the risk for acquiring HIV from sex by about 99% and from injection drug use by at least 74% (20,74,83 ...

8. hiv.gov hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis

Pre-Exposure Prophylaxis PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed. Among people who inject drugs, it reduces the risk by at least 74% when ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2827545

Antiretroviral Drugs for Treatment and Prevention of HIV in ... New data and new antiretroviral drugs and formulations continue to become available for the prevention and management of HIV infection.