Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)

Not Applicable

Recruiting

• Conditions: Transgender Women; Aids; Hiv
• Interventions: Other: Baseline; Other: Control; Other: ENTRUST

• Registration Number: NCT06202898
• Lead Sponsor: University of Central Florida

Brief Summary

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.

Detailed Description

There continues to be a gap in the extant literature on the relationship between substance abuse and achievement of viral suppression (VS) through adherent antiretroviral treatment (ART) or PrEP uptake among transgender women which warrants further investigation. Harmful alcohol and illicit drug use associated with substance use disorders (SUD) have been independently linked to condomless sex and hinder engagement in ending the HIV epidemic (EHE) prevention initiatives, including HIV retention in care and adherence to treatment to achieve viral suppression and PrEP use.

Transgender women are among the most at risk group of sexually active populations, yet least likely to be aware of and/or use preexposure prophylaxis (PrEP) to prevent HIV transmission.5 PrEP and routine HIV/STI screening, are effective approaches to reduce HIV incidence in marginalized at-risk populations and are consistent with the US National HIV/AIDS strategy.

Study Timeline

• Study Start: 2023-07-11
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-11
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

• Aged ≥18 years
• Male at birth
• Identify as a woman/transgender woman
• Should not be consistently using PrEP (less than four doses per week)
• Should not have any known allergy or adverse reaction to PrEP or the active drug tenofovir in ART. One of the goals of the study is to move more people into a PrEP program
• Be able to speak and understand spoken English and/or Spanish (including persons who cannot read or write)
• Have a smart phone that can take pictures

Exclusion Criteria

• Unwilling to adhere to study procedures
• Participation in an HIV vaccine trial
• Have a life-threatening SUD*
• 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
• Unable to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENTRUST	Baseline	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.
Control	Baseline	Comparison control group.
Control	Control	Comparison control group.
ENTRUST	ENTRUST	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with substance abuse	1 year	The rate of change of substance abuse incidence for both arms

Secondary Outcome Measures

Name	Time	Method
Rate of substance use in transgender women	1 year	The rate of stabilizing transgender women financially while providing them tailored counselling to increase their odds of them linking to substance use services, pre-exposure prophylaxis (PrEP) services if they do not have HIV, and transgender women who are living with HIV to be more adherent to their antiretroviral therapy (ART) treatment.

Trial Locations

Locations (1)

University of Central Florida; 🇺🇸 Orlando, Florida, United States