Financial Stability and Counseling for Transgender Women

Overseen By Amoy Fraser, PhD, CCRP, PMP

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: HIV vaccine trial, Life-threatening SUD, 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: Unknown

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if improving financial stability and providing personal counseling for transgender women can enhance their access to health services, such as substance use support or HIV prevention and treatment. The main intervention, ENTRUST, focuses on teaching financial management skills and building social connections. Transgender women who do not regularly use PrEP (Pre-Exposure Prophylaxis, a medication to prevent HIV) and have a smartphone are well-suited for this study. Researchers will compare participants to a control group to assess the intervention's effectiveness. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve health service access for transgender women.

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 mainly focuses on financial stability and counseling for transgender women, with some criteria related to PrEP use.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research does not provide specific safety data for the ENTRUST treatment. ENTRUST is designed to help transgender women achieve financial stability and social support. It is not a drug or medical procedure and therefore does not have typical medical side effects. Instead, ENTRUST aims to improve economic skills and strengthen social connections.

The main safety considerations involve existing medications like PrEP (pre-exposure prophylaxis) for HIV prevention, which transgender women might use alongside ENTRUST. Some studies have raised concerns about interactions between PrEP and hormone therapy, but these concerns are not directly related to the ENTRUST program. Transgender women have used PrEP, though its effectiveness can vary, especially when hormone levels are low.

Overall, ENTRUST itself does not pose traditional medical risks, as it focuses on social and economic support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENTRUST intervention because it tackles the root causes of healthcare disparities faced by transgender women, which many standard treatments don't address. Unlike typical healthcare solutions that mainly focus on medical or psychological support, ENTRUST is designed to enhance economic skills and social cohesion. This unique approach aims to improve access to care by empowering individuals with the tools to navigate economic challenges and strengthen community support networks. By doing so, ENTRUST has the potential to create lasting positive impacts on both the personal and community level for transgender women.

What evidence suggests that the ENTRUST intervention could be effective for transgender women?

Research has shown that financial stability and personalized support significantly help transgender women access medical services, including those for substance use and HIV prevention or treatment. Studies have found that consistent and correct use of PrEP (a medicine to prevent HIV) can be up to 99% effective. However, many transgender women might not know about PrEP or how to obtain it. The ENTRUST program in this trial aims to teach skills for financial stability and build social support, increasing the likelihood of participants accessing necessary healthcare. This approach is based on evidence that addressing broader issues can lead to better health outcomes. ^{1 5 6 7 8}

Who Is on the Research Team?

Elena Cyrus, PhD

Principal Investigator

University of Central Florida

Are You a Good Fit for This Trial?

This trial is for transgender women, particularly those who are financially unstable and may need help with substance use or HIV prevention/treatment. It's open to individuals seeking support in these areas but not to those who don't meet the specific inclusion criteria set by the researchers.

Inclusion Criteria

I was assigned male at birth.

I identify as a woman or transgender woman.

I do not regularly take PrEP, less than four times a week.

Exclusion Criteria

Unwilling to adhere to study procedures

Any condition, that in the opinion of the study staff, would make participation in the study unsafe, or interfere with achieving the study objective such as medical conditions which prevents the use of PrEP

I am unable to give my consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive skills training for economic navigation and social cohesion to increase linkage to care

12 months

Follow-up

Participants are monitored for changes in substance abuse incidence and linkage to care

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ENTRUST

Trial Overview The ENTRUST trial is testing whether financial stability and tailored counseling can help transgender women better access services for substance use, PrEP (HIV prevention), or adhere to their ART (HIV treatment) if they are living with HIV.

How Is the Trial Designed?

Group I: ENTRUST Experimental Treatment 2 Interventions

The proposed intervention 'ENTRUST' will address structural disparities transgender women encounter by providing skills to aid with economic navigation while simultaneously strengthening and improving social cohesion to increase the odds of them linking to care that is available to them.

Group II: Control Active Control 2 Interventions

Comparison control group.

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 of Drug Abuse

Collaborator

Trials

11

Recruited

12,500+

Survivor's Pathway

Collaborator

Trials

1

Recruited

110+

Sunserve

Collaborator

Trials

1

Recruited

110+

26Health

Collaborator

Trials

1

Recruited

110+

Published Research Related to This Trial

Most transgender and gender nonbinary (TGNB) youth aged 15-24 are aware of pre-exposure prophylaxis (PrEP), but only one participant reported currently using it, highlighting a significant gap in uptake.

Concerns about medication costs and potential interactions between PrEP and hormone treatments may contribute to hesitancy in using PrEP, indicating a need for targeted outreach and education for TGNB youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Underutilization of Pre-Exposure Prophylaxis Services Among Transgender and Nonbinary Youth: Findings from Project Moxie and TechStep. Horvath, KJ., Todd, K., Arayasirikul, S., et al.[2020]

Older age, being white, and identifying as a cisgender man were associated with higher odds of using pre-exposure prophylaxis (PrEP), indicating demographic factors significantly influence PrEP uptake.

Living in states that expanded Medicaid was linked to increased PrEP use, but overall, state residency did not explain the disparities in PrEP uptake, particularly among young MSM and TGNB individuals of color who are at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic, clinical guideline criteria, Medicaid expansion and state of residency: a multilevel analysis of PrEP use on a large US sample. Carneiro, PB., Mirzayi, C., Jones, S., et al.[2022]

In a survey of 126 transgender women in Detroit, 56% of those with negative or unknown HIV status reported risk behaviors that indicated a need for PrEP, but only 17% were currently taking it.

Many transgender women expressed low interest in PrEP, but about 60% indicated they would be more likely to use it if it were offered at clinics that also provide hormone replacement therapy, highlighting the need for tailored healthcare services for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting pre-exposure prophylaxis to high-risk transgender women: lessons from Detroit, USA. Hood, JE., Eljallad, T., Abad, J., et al.[2019]

In the SHIPP Study, which included 510 transgender participants, adherence to daily oral PrEP was high initially, with 100% of participants reporting taking 4 or more doses in the past week at the 3-month follow-up, but adherence declined over time.

Despite high self-reported adherence, objective measures showed that fewer participants maintained the same level of adherence at clinical visits, highlighting the need for targeted strategies to improve and sustain PrEP adherence among transgender individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEP Use and Adherence among Transgender Persons in Chicago, IL (SHIPP Study, 2014-2018, USA). Townes, A., Pyra, M., Smith, DK., et al.[2023]

A targeted PrEP policy for high-risk cisgender men who have sex with men (MSM) and transgender women (TGW) can significantly reduce HIV incidence, achieving a 1.95% reduction in one year and 3.83% over two years by focusing on just 59.7% of the population.

This approach is as effective as broader guidelines that recommend PrEP to a larger group based on multiple risk factors, suggesting that prioritizing high-risk subpopulations can optimize resource use in HIV prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the impact of policies recommending PrEP to subpopulations of men and transgender women who have sex with men based on demographic and behavioral risk factors. Janes, H., Brown, MD., Glidden, DV., et al.[2023]

Transgender individuals, particularly transfeminine respondents, showed low familiarity with PrEP despite having favorable attitudes towards it, highlighting a gap in awareness that needs to be addressed for effective HIV prevention.

Only 3% of respondents reported currently using PrEP, and those with higher levels of nonaffirmation of their gender identity were less likely to use it, indicating that social factors may hinder access to this preventive measure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Testing and PrEP Use in a National Probability Sample of Sexually Active Transgender People in the United States. Sevelius, JM., Poteat, T., Luhur, WE., et al.[2023]

Transgender women in urban settings who face psychosocial and structural barriers, such as substance use and incarceration history, are more likely to use PrEP, highlighting a complex relationship between challenges and health-seeking behavior.

Facilitators like gender affirmation positively influence recent PrEP use, suggesting that supportive environments can enhance access to HIV prevention strategies among transgender women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional analysis of psychosocial and structural barriers and facilitators associated with PrEP use among a sample of transgender women in Chicago, IL. Kuhns, LM., Perloff, J., Johnson, AK., et al.[2023]

In a study involving 48 participants (24 transgender men and 24 transgender women) over 4 weeks, the use of the PrEP drug FTC/TDF did not affect serum hormone levels, indicating that PrEP is safe for individuals on hormone therapy.

All groups, including transgender men, transgender women, and cisgender men, achieved comparable levels of TFV-DP, which is associated with high protection against HIV, suggesting that PrEP is effective across these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study. Grant, RM., Pellegrini, M., Defechereux, PA., et al.[2022]

The Triunfo project successfully engaged Spanish-speaking transgender Latinas in HIV pre-exposure prophylaxis (PrEP) services by creating a trusted and welcoming healthcare environment, which was crucial for participants who had previously avoided healthcare due to experiences of discrimination.

Key elements of the intervention included comprehensive patient navigation and social support from peer health educators, which empowered participants to initiate and continue PrEP, highlighting the importance of culturally competent and gender-affirming care in improving health outcomes for marginalized communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Entre Nosotras:" a qualitative study of a peer-led PrEP project for transgender latinas. Zamudio-Haas, S., Koester, K., Venegas, L., et al.[2023]

In a study of 168 HIV-uninfected transgender women in Ho Chi Minh City, 72.6% met the criteria for HIV pre-exposure prophylaxis (PrEP) based on CDC guidelines, indicating a significant potential need for PrEP in this population.

Despite the high indication for PrEP, awareness and readiness to use it were very low, with only 7.7% of participants being aware of PrEP and believing it to be effective, highlighting the need for targeted education and counseling in future PrEP implementation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Pre-exposure Prophylaxis Indication and Readiness Among HIV-Uninfected Transgender Women in Ho Chi Minh City, Vietnam. Oldenburg, CE., Le, B., Toan, T., et al.[2018]

Knowledge and use of PrEP among transgender women in San Francisco have significantly increased, with 94% aware of PrEP, 64.7% discussing it with healthcare providers, and 44.8% having used it in the past year.

PrEP use was strongly linked to participation in a PrEP demonstration project and engaging in condomless receptive anal intercourse, while injection drug use was associated with lower PrEP use, highlighting the need for targeted interventions to address stigma and improve access to preventive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved PrEP Awareness and Use among Trans Women in San Francisco, California. Wilson, EC., Hernandez, CJ., Scheer, S., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-hiv-2024-e54d3

Financial Stability and Counseling for Transgender Women The research does not provide specific safety data for PrEP in transgender women, but it highlights concerns about potential interactions with hormone therapy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4454556/

Knowledge, Indications and Willingness to Take Pre- ... We found that of 233 transwomen, only 13.7% had heard of PrEP. Transwomen who were living with HIV compared to those who were HIV-negative, and ...

3. aidsmap.com aidsmap.com/news/nov-2015/truvada-prep-appears-work-transgender-women-only-if-used-consistently

Truvada PrEP appears to work for transgender women, but ... Among transgender women, 11 new HIV infections occurred in the PrEP group and 10 in the placebo group during the randomised study – essentially ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6859945/

A Promising PrEP Navigation Intervention for Transgender ... Data from the iPrEx randomized controlled trial and open-label extension study of PrEP with trans women and MSM indicated that PrEP is up to 99% effective when ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04742491

Pre-Exposure Prophylaxis for Transgender Women in the ... A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02842086

NCT02842086 | Study to Evaluate the Safety and Efficacy ... The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5111857/

HIV pre-exposure prophylaxis in transgender women TGW receiving PrEP had low drug concentrations, especially at times of potential HIV exposure, leading to no PrEP effectiveness among this subgroup.

8. cdc.gov cdc.gov/mmwr/volumes/73/su/su7301a2.htm

National HIV Behavioral Surveillance Among Transgender ... PrEP use also was reported by 33.0% of transgender women who injected drugs and by 44.0% who shared a syringe to inject drugs or for gender ...