Recruiting

Observational Study

Sponsor:

University of Central Florida

Code:

NCT06202898

Conditions

Transgender Women

Aids

Hiv

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Baseline

ENTRUST

Control

Study Details

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

Study ID

NCT06202898

Start date

Jul 11, 2023

Status verified date

Dec, 2024

Completion date

Jun, 2027

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

active comparator: Control

Comparison control group.

Interventions

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

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.

Control

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

Primary outcome measure

  • Number of participants with substance abuse [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Elena Cyrus, PhD

4072661507elena.cyrus@ucf.edu

Amoy Fraser, PhD, CCRP, PMP

4072668742amoy.fraser@ucf.edu

Locations

University of Central Florida

Recruiting

Orlando, Florida, United States, 32827

Contacts

Elena Cyrus, PhD

4072661125elena.cyrus@ucf.edu

Eric Schrimshaw, PhD

407-266-1501eric.schrimshaw@ucf.edu

More Information

Sponsor

University of Central Florida

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Central Florida on 2024-12-06.