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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202898
• Other study ID #: STUDY00005488
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: University of Central Florida
• Contact: Elena Cyrus, PhD
• Phone: 4072661507
• Email: elena.cyrus[@]ucf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2027
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aids
• Hiv
• Transgender Women

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of Central Florida	26Health, National Institute of Drug Abuse, Sunserve, Survivor's Pathway

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with substance abuse	The rate of change of substance abuse incidence for both arms	1 year
Secondary	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