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

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.

Study Overview

• Status: Recruiting
• Conditions: Transgender Women; Hiv; Aids
• Intervention / Treatment: Other: Baseline; Other: Control; Other: ENTRUST

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Cyrus, PhD; Phone Number: 4072661507; Email: elena.cyrus@ucf.edu
• Study Contact Backup: Name: Amoy Fraser, PhD, CCRP, PMP; Phone Number: 4072668742; Email: Amoy.Fraser@UCF.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • University of Central Florida
      • Contact: Eric Schrimshaw, PhD; Phone Number: 407-266-1501; Email: eric.schrimshaw@ucf.edu
      • Contact: Elena Cyrus, PhD; Phone Number: 4072661125; Email: elena.cyrus@ucf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Baseline; At the baseline visits, all study participants will be complete an interviewer-assisted questionnaire using REDCap, and will also receive the SBIRT-T MI-based intervention. Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for strength sessions, and they will be provided with a schedule of strength session visits; Other: ENTRUST; Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for economic strength sessions, group-based economic training through photovoice activities and adapted screening brief intervention and treatment (SBIRT-T) adapted for transgender women delivered by a facilitator or digitally.
Active Comparator: Control; Comparison control group.	Other: Baseline; At the baseline visits, all study participants will be complete an interviewer-assisted questionnaire using REDCap, and will also receive the SBIRT-T MI-based intervention. Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for strength sessions, and they will be provided with a schedule of strength session visits; Other: Control; participants assigned to the control arm will have the option of participating in the four additional strength sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with substance abuse	The rate of change of substance abuse incidence for both arms	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of substance use in transgender women	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.	1 year

Collaborators and Investigators

• Sponsor: University of Central Florida
• Collaborators: National Institute of Drug Abuse; Sunserve; Survivor's Pathway; 26Health
• Investigators: Principal Investigator: Elena Cyrus, PhD, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00005488

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No