Clinical trial NCT06202898: Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)
Official title: Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transgender Women
Aids
Hiv
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: Sunserve
name: Survivor's Pathway
name: 26Health
name: National Institute of Drug Abuse
First posted: 2024-01-12
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with substance abuse
timeFrame: 1 year
Secondary outcomes:
measure: Rate of substance use in transgender women
timeFrame: 1 year
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Elena Cyrus, PhD
role: PRINCIPAL_INVESTIGATOR
References: