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

Trial Summary

What is the purpose of this trial?

The overall hypothesis is that stabilizing transgender women financially while providing them tailored counselling will increase their odds of them linking to substance use services, PrEP services if they do not have HIV, and transgender women who are living with HIV will be more adherent to their ART treatment.

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.

What data supports the effectiveness of the drug Truvada for Pre-Exposure Prophylaxis in transgender women?

Research shows that Truvada, used as Pre-Exposure Prophylaxis (PrEP), is a highly effective strategy for preventing HIV infection among transgender women, although awareness and use of PrEP in this group are still limited. Efforts to increase PrEP awareness and address barriers to its use are needed to ensure transgender women can benefit from this preventive measure. ^{1 2 3 4 5}

Is Pre-Exposure Prophylaxis (PrEP) safe 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. More studies are needed to fully understand these interactions. ^{1 6 7 8 9}

How is the drug ENTRUST (Truvada, PrEP) unique for transgender women?

ENTRUST, also known as Truvada or PrEP, is unique for transgender women as it combines HIV prevention with financial stability and counseling, addressing both health and socio-economic challenges. This approach is novel because it integrates HIV prevention with gender-affirming care and support services, which are often underutilized in this group. ^{1 4 8 10 11}

Research Team

Elena Cyrus, PhD

Principal Investigator

University of Central Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]

References

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

Underutilization of Pre-Exposure Prophylaxis Services Among Transgender and Nonbinary Youth: Findings from Project Moxie and TechStep. [2020]

2. Australia pubmed.ncbi.nlm.nih.gov

Getting pre-exposure prophylaxis to high-risk transgender women: lessons from Detroit, USA. [2019]

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

HIV Pre-exposure Prophylaxis Indication and Readiness Among HIV-Uninfected Transgender Women in Ho Chi Minh City, Vietnam. [2018]

4. England 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. [2023]

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

Improved PrEP Awareness and Use among Trans Women in San Francisco, California. [2022]

6. United States 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. [2023]

7. United States 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. [2022]

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

HIV Testing and PrEP Use in a National Probability Sample of Sexually Active Transgender People in the United States. [2023]

9. England 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

"Entre Nosotras:" a qualitative study of a peer-led PrEP project for transgender latinas. [2023]

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

PrEP Use and Adherence among Transgender Persons in Chicago, IL (SHIPP Study, 2014-2018, USA). [2023]