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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06202898
Recruitment Status : Recruiting
First Posted : January 12, 2024
Last Update Posted : April 12, 2024
Sponsor:
Collaborators:
Sunserve
Survivor's Pathway
26Health
National Institute of Drug Abuse
Information provided by (Responsible Party):
University of Central Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transgender Women Aids Hiv Other: Baseline Other: ENTRUST Other: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)
Actual Study Start Date : January 1, 2024
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV LGBTQIA+ Health

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with substance abuse [ Time Frame: 1 year ]
    The rate of change of substance abuse incidence for both arms


Secondary Outcome Measures :
  1. Rate of substance use in transgender women [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Identify as a woman/transgender woman
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06202898


Contacts
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Contact: Elena Cyrus, PhD 4072661507 elena.cyrus@ucf.edu
Contact: Amoy Fraser, PhD, CCRP, PMP 4072668742 amoy.fraser@ucf.edu

Locations
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United States, Florida
University of Central Florida Recruiting
Orlando, Florida, United States, 32827
Contact: Elena Cyrus, PhD    407-266-1125    elena.cyrus@ucf.edu   
Contact: Eric Schrimshaw, PhD    407-266-1501    eric.schrimshaw@ucf.edu   
Sponsors and Collaborators
University of Central Florida
Sunserve
Survivor's Pathway
26Health
National Institute of Drug Abuse
Investigators
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Principal Investigator: Elena Cyrus, PhD University of Central Florida
More Information
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Responsible Party: University of Central Florida
ClinicalTrials.gov Identifier: NCT06202898    
Other Study ID Numbers: STUDY00005488
First Posted: January 12, 2024    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No