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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

Transgender women in Florida are economically disadvantaged and at highest risk for substance use disorders, HIV transmission and/or non-adherence to antiretroviral treatment, yet remain underrepresented in research. Existing programs fail to address structural barriers such as socio-economic status and social marginalization that deter access to prevention services and care. For this study, acceptability, feasibility, and preliminary efficacy of ENTRUST (economic navigation and strengthening to realize unrestricted services for transgender women) will be assessed. ENTRUST is an economic-based empowerment intervention that will provide transgender women with group-based financial education while receiving tailored SBIRT counseling to help transgender women routinely engaging in substance use services and HIV care or preexposure prophylaxis (PrEP) programs. Participants will be assigned to either the ENTRUST intervention arm or a waitlist control arm. Participants in the intervention arm will receive the ENTRUST intervention during 6-month follow up, and participants assigned to the control arm will have the option of receiving the ENTRUST intervention at the end of the study. Participants in the intervention arm must complete about half of the visits in person, and participants in the control arm will have the option of completing the study visits remotely or in person. All participants will be followed for six months and will complete 4 - 15 study visits. In person site visits will occur at one of our participating sites in Orlando or Miami and will be conducted in English and/or Spanish only. Participants must be adults (over the age) and residing in South or Central Florida. Participants can be enrolled in the study for 6 - 8 months.

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 data supports the effectiveness of the drug Truvada in the ENTRUST Program for Substance Use Disorder and HIV/AIDS?

Research shows that Truvada, a combination of emtricitabine and tenofovir, is effective in preventing HIV transmission in various groups, including men who have sex with men and heterosexual couples. It is the only drug approved to prevent HIV infections and is a key component of pre-exposure prophylaxis (PrEP), which aims to prevent HIV infection and transmission. ^{1 2 3 4 5}

Is the ENTRUST treatment generally safe for humans?

The treatment, known as Truvada or Pre-Exposure Prophylaxis (PrEP), has been shown to have a good safety profile in clinical trials, with common mild side effects like nausea and diarrhea. Regular monitoring is recommended to prevent long-term effects on liver, kidneys, and bones. ^{1 2 4 6 7}

How is the drug Truvada unique in treating substance use disorder and HIV/AIDS?

Truvada, used as pre-exposure prophylaxis (PrEP), is unique because it is the only drug approved to prevent HIV infections, focusing on prevention rather than treatment. It combines two medications, tenofovir and emtricitabine, to reduce the risk of HIV transmission, especially in high-risk individuals. ^{1 2 4 6 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Regimen Change: Gilead's TAF Drugs Toppling TDFs in HIV Treatment. [2021]

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

Prevention of vaginal SHIV transmission in macaques by a coitally-dependent Truvada regimen. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

HIV Pre-Exposure Prophylaxis - Is it just about pills? [2017]

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

The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. [2023]

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

Predictors of Preexposure Prophylaxis Eligibility among Pregnant People with Opioid Use Disorder. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]

7. United States 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. [2022]

8. Canada 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. [2023]