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

University of Central Florida

Status: Enrolling

Conditions: Transgender Women; Hiv; Aids

Treatments: Other: ENTRUST; Other: Baseline; Other: Control

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06202898

STUDY00005488

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

ENTRUST

Experimental group

Description:

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.

Treatment:

Other: Baseline

Other: ENTRUST

Control

Active Comparator group

Description:

Comparison control group.

Treatment:

Other: Control

Other: Baseline