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

NCT06202898 | Recruiting

• 1 other identifier: STUDY00005488
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Transgender Women; Aids; Hiv

Outcome Measures

Primary Outcomes (1)

• Number of participants with substance abuse

  The rate of change of substance abuse incidence for both arms

  1 year

Secondary Outcomes (1)

• Rate of substance use in transgender women

  1 year

Study Arms (2)

ENTRUST

EXPERIMENTAL

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; Other: ENTRUST

Control

ACTIVE COMPARATOR

Comparison control group.

Other: Baseline; Other: Control

Interventions

Baseline OTHER

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

Control; ENTRUST

ENTRUST OTHER

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.

ENTRUST

Control OTHER

participants assigned to the control arm will have the option of participating in the four additional strength sessions.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as a woman/transgender woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead
• Sunserve: collaborator
• Survivor's Pathway: collaborator
• 26Health: collaborator
• National Institute of Drug Abuse: collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Elena Cyrus, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Cyrus, PhD

CONTACT

4072661507; elena.cyrus@ucf.edu

Amoy Fraser, PhD, CCRP, PMP

CONTACT

4072668742; amoy.fraser@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 12, 2024
• Study Start: July 11, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)